Development and Piloting of a Family-Centered, mHealth-Enhanced Intervention to Promote Caregiving Mastery in Detection, Prevention, and Management of Delirium Superimposed on Dementia
Phase: NA
Conditions: Delirium Superimposed on Dementia
Sponsor: NYU Langone Health

Official Title:
Development and Piloting of a Family-Centered, mHealth-Enhanced 
Intervention to Promote Caregiving Mastery in Detection, Prevention, 
and Management of Delirium Superimposed on Dementia  
NCT Number:
NCT05630014
Study Number:
22-01093 
Document Type:
Study Protocol and Statistical Analysis Plan
Date of the 
Document: 
 
April 28, 2024 

Page i 
CONFIDENTIAL
This material is the property of the NYU Langone Health.  Do not disclose or use except as authorized in writing by the study
sponsor
Behavioral Intervention Template Version: 18 July 2022
DEVELOPMENT AND PILOTING OF A FAMILY-CENTERED, MHEALTH-
ENHANCED INTERVENTION TO PROMOTE CAREGIVING MASTERY 
IN DETECTION, PREVENTION, AND MANAGEMENT OF DELIRIUM 
SUPERIMPOSED ON DEMENTIA
Principal Investigator:
Shih-Yin Lin, PhD, MPH, MM
NYU Rory Meyers College of Nursing
433 First Avenue, #745M, New York, NY10010
sl199@nyu.edu
(720) 883-5715 (cell)
Additional Investigators:
  
Yong K. Choi, PhD, MPH
Department of Health Information Management
School of Health and Rehabilitation Science
University of Pittsburgh
6051B Forbes Tower, 3600 Atwood St, Pittsburgh, PA 15260
yong.choi@pitt.edu
(206) 496-2147
NYULMC Study Number:
s22-01093
Funding Sponsor: 
NIH-NIA (through Emory Roybal Center for Dementia 
Caregiving Mastery)
5P30AG064200-04 (Subaward #A684268)
ClinicalTrials.gov 
Number                
NCT05630014
Initial version:
11/04/2022
Amended:
12/21/2022
Amended:
02/28/2023
Amended: 
11/29/2023
Amended:          02/14/2024 
Amended:  
04/15/2024

Study number: s22-01093
Page ii
Version: 6.0     Date: 04/15/2024 
 
 
CONFIDENTIAL 
This material is the property of the NYU Langone Health.  Do not disclose or use except as authorized in writing by the study 
sponsor 
Behavioral Intervention Template Version: 18 July 2022
 
Statement of Compliance 
This study will be conducted in accordance with the Code of Federal Regulations on the Protection of 
Human Subjects (45 CFR Part 46), any other applicable US government research regulations, and 
institutional research policies and procedures. The Principal Investigator will assure that no deviation from, 
or changes to the protocol will take place without prior agreement from the sponsor and documented 
approval from the Institutional Review Board (IRB), except where necessary to eliminate an immediate 
hazard(s) to the trial participants. All personnel involved in the conduct of this study have completed Human 
Subjects Protection Training. 
 
 

Study number: s22-01093
Page iii
Version: 6.0     Date: 04/15/2024 
 
 
CONFIDENTIAL 
This material is the property of the NYU Langone Health.  Do not disclose or use except as authorized in writing by the study 
sponsor 
Behavioral Intervention Template Version: 18 July 2022
Table of Contents 
PROTOCOL SUMMARY .............................................................................................................................. 1
SCHEMATIC OF STUDY DESIGN ............................................................................................................... 3
1
KEY ROLES......................................................................................................................................... 5
2 
INTRODUCTION, BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE ....................... 8
2.1 
BACKGROUND INFORMATION AND RELEVANT LITERATURE ................................................................ 8
2.1.1
Theoretical Framework/Mechanism ........................................................................................ 8
2.2 
RATIONALE.................................................................................................................................... 9
2.3 
POTENTIAL RISKS & BENEFITS ...................................................................................................... 10
2.3.1
Known Potential Risks...........................................................................................................10
2.3.2 
Risk of Use of Mobile Health Technology ............................................................................. 10
2.3.3 
Risk of Use of Text Messaging .............................................................................................. 11
2.3.4
Known Potential Benefits ......................................................................................................11
3 
OBJECTIVES AND PURPOSE ......................................................................................................... 11
3.1 
PRIMARY OBJECTIVE .................................................................................................................... 11
3.2
SECONDARY OBJECTIVES (IF APPLICABLE) ....................................................................................11
4 
STUDY DESIGN AND ENDPOINTS .................................................................................................. 11
4.1 
DESCRIPTION OF STUDY DESIGN .................................................................................................. 11
4.2 
STUDY ENDPOINTS....................................................................................................................... 12
4.2.1 
Primary Study Endpoints ....................................................................................................... 12
4.2.2 
Secondary Study Endpoints .................................................................................................. 12
4.2.3 
Exploratory Endpoints ........................................................................................................... 13
5 
STUDY ENROLLMENT AND WITHDRAWAL .................................................................................. 13
5.1 
INCLUSION CRITERIA .................................................................................................................... 13
5.2 
EXCLUSION CRITERIA ................................................................................................................... 13
5.3 
VULNERABLE SUBJECTS............................................................................................................... 13
5.4 
STRATEGIES FOR RECRUITMENT AND RETENTION .......................................................................... 14
5.4.1 
Use of DataCore/Epic Information for Recruitment Purposes .............................................. 14
5.4.2 
Caregiver Self-Referrals ........................................................................................................ 14
5.4.3 
Family Caregiver Registry ..................................................................................................... 14
5.4.4 
Clinician Referral ................................................................................................................... 14
5.4.5
Study Flyers (general), Facebook Recruitment, Recruitment Text Messages, and Information 
Sessions ............................................................................................................................................. 15
5.5
DURATION OF STUDY PARTICIPATION............................................................................................15
5.6 
TOTAL NUMBER OF PARTICIPANTS AND SITES ................................................................................ 15
5.7 
PARTICIPANT WITHDRAWAL OR TERMINATION................................................................................ 16
5.7.1 
Reasons for Withdrawal or Termination ................................................................................ 16
5.7.2 
Handling of Participant Withdrawals or Termination ............................................................. 16
5.7.3 
Premature Termination or Suspension of Study ................................................................... 17
6 
BEHAVIORAL/SOCIAL INTERVENTION ......................................................................................... 17
6.1 
STUDY BEHAVIORAL OR SOCIAL INTERVENTION(S) DESCRIPTION.................................................... 17
6.1.1 
Administration of Intervention ................................................................................................ 18
6.1.2 
Procedures for Training Interventionalists and Monitoring Intervention Fidelity ................... 18
6.1.3 
Assessment of Subject Compliance with Study Intervention ................................................ 18
7 
STUDY PROCEDURES AND SCHEDULE ....................................................................................... 19
7.1 
STUDY PROCEDURES/EVALUATIONS ............................................................................................. 19
7.1.1 
Study Specific Procedures .................................................................................................... 19
7.1.2 
Standard of Care Study Procedures ..................................................................................... 21

Study number: s22-01093
Page iv
Version: 6.0     Date: 04/15/2024 
 
 
CONFIDENTIAL 
This material is the property of the NYU Langone Health.  Do not disclose or use except as authorized in writing by the study 
sponsor 
Behavioral Intervention Template Version: 18 July 2022
7.2 
LABORATORY PROCEDURES/EVALUATIONS ................................................................................... 21
7.2.1
Clinical Laboratory Evaluations.............................................................................................21
7.2.2 
Other Assays or Procedures ................................................................................................. 21
7.2.3 
Specimen Preparation, Handling, and Storage ..................................................................... 21
7.2.4
Specimen Shipment ..............................................................................................................21
7.3 
STUDY SCHEDULE........................................................................................................................ 21
7.3.1 
Screening .............................................................................................................................. 21
7.3.2
Enrollment/Baseline ..............................................................................................................23
7.3.3 
Intermediate Visits ................................................................................................................. 23
7.3.4 
Final Study Visit ..................................................................................................................... 24
7.3.5
Withdrawal Visit.....................................................................................................................24
7.3.6 
Unscheduled Visit .................................................................................................................. 24
7.4 
CONCOMITANT MEDICATIONS, TREATMENTS, AND PROCEDURES .................................................... 25
7.5
JUSTIFICATION FOR SENSITIVE PROCEDURES................................................................................25
7.5.1 
Precautionary Medications, Treatments, and Procedures .................................................... 25
7.6 
PROHIBITED MEDICATIONS, TREATMENTS, AND PROCEDURES ........................................................ 25
7.7
PROPHYLACTIC MEDICATIONS, TREATMENTS, AND PROCEDURES...................................................25
7.8 
PARTICIPANT ACCESS TO STUDY INTERVENTION AT STUDY CLOSURE............................................. 25
8 
ASSESSMENT OF SAFETY ............................................................................................................. 25
8.1 
SPECIFICATION OF SAFETY PARAMETERS...................................................................................... 25
8.1.1 
Definition of Adverse Events (AE) ......................................................................................... 25
8.1.2 
Definition of Serious Adverse Events (SAE) ......................................................................... 25
8.1.3 
Definition of Unanticipated Problems (UP) ............................................................................ 26
8.2 
CLASSIFICATION OF AN ADVERSE EVENT ....................................................................................... 26
8.2.1 
Severity of Event ................................................................................................................... 26
8.2.2 
Relationship to Study Intervention......................................................................................... 26
8.2.3 
Expectedness ........................................................................................................................ 26
8.3 
TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP.................................... 26
8.4 
REPORTING PROCEDURES – NOTIFYING THE IRB .......................................................................... 29
8.4.1 
Adverse Event Reporting ...................................................................................................... 29
8.4.2 
Serious Adverse Event Reporting ......................................................................................... 29
8.4.3 
Reporting of Pregnancy ......................................................................................................... 29
8.5 
REPORTING PROCEDURES – NOTIFYING THE STUDY SPONSOR...................................................... 29
8.6 
STUDY HALTING RULES................................................................................................................ 30
8.7 
SAFETY OVERSIGHT ..................................................................................................................... 30
9 
STUDY MONITORING ....................................................................................................................... 31
10
STATISTICAL CONSIDERATIONS .................................................................................................. 31
10.1
STATISTICAL AND ANALYTICAL PLANS ........................................................................................... 31
10.2
STATISTICAL HYPOTHESES...........................................................................................................31
10.3
ANALYSIS DATASETS .................................................................................................................... 32
10.4
DESCRIPTION OF STATISTICAL METHODS ...................................................................................... 32
10.4.1 General Approach ................................................................................................................. 32
10.4.2 Analysis of the Primary Efficacy Endpoint(s) ........................................................................ 32
10.4.3 Analysis of the Secondary Endpoint(s) ................................................................................. 32
10.4.4 Safety Analyses ..................................................................................................................... 32
10.4.5 Adherence and Retention Analyses ...................................................................................... 32
10.4.6 Baseline Descriptive Statistics .............................................................................................. 32
10.4.7 Planned Interim Analysis ....................................................................................................... 32
10.4.8 Additional Sub-Group Analyses ............................................................................................ 33
10.4.9 Multiple Comparison/Multiplicity ............................................................................................ 33
10.4.10 Tabulation of Individual Response Data ............................................................................... 33
10.4.11 Exploratory Analyses ............................................................................................................. 33
10.5
SAMPLE SIZE............................................................................................................................... 33
10.6
MEASURES TO MINIMIZE BIAS ....................................................................................................... 33

Study number: s22-01093
Page v
Version: 6.0     Date: 04/15/2024 
 
 
CONFIDENTIAL 
This material is the property of the NYU Langone Health.  Do not disclose or use except as authorized in writing by the study 
sponsor 
Behavioral Intervention Template Version: 18 July 2022
10.6.1 Enrollment/Randomization/Masking Procedures .................................................................. 33
10.6.2
Evaluation of Success of Blinding .........................................................................................33
10.6.3 Breaking the Study Blind/Participant Code ........................................................................... 33
11
SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS ................................. 33
12
QUALITY ASSURANCE AND QUALITY CONTROL .......................................................................34
13
ETHICS/PROTECTION OF HUMAN SUBJECTS ............................................................................. 34
13.1
ETHICAL STANDARD ..................................................................................................................... 34
13.2
INSTITUTIONAL REVIEW BOARD.....................................................................................................34
13.3
INFORMED CONSENT PROCESS .................................................................................................... 34
13.3.1 Consent/Assent and Other Informational Documents Provided to Participants ................... 34
13.3.2
Consent Procedures and Documentation .............................................................................35
13.3.3 Waiver of Authorization/Consent ........................................................................................... 35
13.4
POSTING OF CLINICAL TRIAL CONSENT FORM ................................................................................ 35
13.5
PARTICIPANT AND DATA CONFIDENTIALITY ....................................................................................36
13.5.1 Research Use of Stored Human Samples, Specimens, or Data .......................................... 36
13.6
FUTURE USE OF STORED SPECIMENS ........................................................................................... 36
14
DATA HANDLING AND RECORD KEEPING ................................................................................... 36
14.1
DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES..............................................................36
14.1.1 Data Collection in REDCap Online Survye Questinonaires .................................................. 37
14.1.2 Data Collection Tools – Mobile Health Technology .............................................................. 38
14.2
STUDY RECORDS RETENTION ....................................................................................................... 38
14.3
PROTOCOL DEVIATIONS ............................................................................................................... 38
14.4
PUBLICATION AND DATA SHARING POLICY..................................................................................... 39
15
STUDY FINANCES ............................................................................................................................ 39
15.1
FUNDING SOURCE ........................................................................................................................ 39
15.2
COSTS TO THE PARTICIPANT ......................................................................................................... 40
15.3
PARTICIPANT REIMBURSEMENTS OR PAYMENTS ............................................................................ 40
16
STUDY ADMINISTRATION ............................................................................................................... 40
16.1
STUDY LEADERSHIP ..................................................................................................................... 40
17
CONFLICT OF INTEREST POLICY .................................................................................................. 40
18
REFERENCES ................................................................................................................................... 40
19
ATTACHMENTS ................................................................................................................................ 43
 
 

Study number: s22-01093
Page vi
Version: 6.0     Date: 04/15/2024 
 
 
CONFIDENTIAL 
This material is the property of the NYU Langone Health.  Do not disclose or use except as authorized in writing by the study 
sponsor 
Behavioral Intervention Template Version: 18 July 2022
 
List of Abbreviations
AE
Adverse Event/Adverse Experience
CFR
Code of Federal Regulations
CRF
Case Report Form
CSOC
Clinical Study Oversight Committee
DCC
Data Coordinating Center
DSD
Delirium Superimposed on Dementia
DHHS
Department of Health and Human Services 
DSMB 
Data and Safety Monitoring Board 
FFR 
Federal Financial Report 
FWA 
Federalwide Assurance
GCP
Good Clinical Practice
HIPAA
Health Insurance Portability and Accountability Act 
ICF
Informed Consent Form 
IRB
Institutional Review Board
ISM
Independent Safety Monitor 
MOP 
Manual of Procedures
N 
Number (typically refers to participants) 
NIH
National Institutes of Health 
OHRP 
Office for Human Research Protections 
OHSR 
Office of Human Subjects Research 
PI 
Principal Investigator 
PLWD 
Persons Living with Dementia
QA
Quality Assurance
QC
Quality Control
SAE
Serious Adverse Event/Serious Adverse Experience
SOP 
Standard Operating Procedure
US 
United States

Study number: s22-01093
page 1
Version: 1.0 
CONFIDENTIAL 
This material is the property of the NYU School of Medicine and Langone Health.  Do not disclose or use except as authorized in 
writing by the study sponsor 
Drug/Device Template Version: 11 Jan 2019
Protocol Summary
Title 
Development and Piloting of a Family-Centered, mHealth-Enhanced 
Intervention to Promote Caregiving Mastery in Detection, Prevention, and 
Management of Delirium Superimposed on Dementia
Short Title
A Pilot Study of the Aliviado DSD Caregiving Mastery Program
Brief Summary 
Delirium superimposed on dementia (DSD) is an acute and serious condition 
that is common in persons living with dementia (PLWD). Involvement of 
family caregivers may aid prevention, early detection, and management of 
DSD. The purpose of the proposed study is two-fold. First, we will develop a 
family-centered, mHealth-enhanced DSD caregiving mastery program 
(“Aliviado DSD Caregiving Mastery Program”) through a 5-week co-design 
workshop with 8 family caregivers (Aim 1). We will adapt/refine the existing 
clinician-centered DSD contents and an mHealth app from the evidence-
based “Aliviado Dementia Care” program for use by family caregivers to 
support their day-to-day implementation of DSD detection, prevention, and 
management tasks in the community. Second, we will pilot test the full 
Aliviado DSD Caregiving Mastery Program with 30 family caregivers of 
PLWD at high risk for delirium, assessing feasibility, acceptability, app 
usability, and preliminary program impact (Aim 2). 
Phase 
Phase I (NIH Stage I) 
Objectives 
1.
To adapt the existing Aliviado app for use by family caregivers
2. Assess feasibility, acceptability, app usability, and preliminary impact of 
the Aliviado DSD Caregiving Mastery Program.
Methodology 
1.
Co-design workshop 
2.
A single-arm, pre-post study 
Endpoint 
Primary endpoints: feasibility, acceptability, and app usability  
Secondary endpoints: caregivers’ delirium knowledge, caregiving mastery, 
strain, depression, and burden
Study Duration 
12 months 
Participant Duration 
10 months 
Duration of behavioral 
intervention 
6 weeks 
Population
Adult family caregivers of community dwelling PLWD. “Adults” are individuals 
who are 18 years of age and older. “Family caregivers” are relatives or 
friends who provide unpaid care to PLWD. 
Study Sites 
NYU and University of Pittsburg 
Number of participants 
Aim 1: 8 family caregivers 
Aim 2: 30 primary caregivers plus 0 to 30 optional secondary caregivers 
Optional: Enrolled primary caregivers can choose to invite additional relatives 
or friends to participate in the Aim 2 pilot study as “secondary caregivers”.   
Description of Study 
Intervention/Procedure 
Intervention: Aliviado DSD Caregiving Mastery Program, a family caregiver 
intervention consisting of mHealth-app based educational videos and articles; 
caregiver-administered assessment tools and care plans; and motivational 
push notification or text message reminders and encouragements.  
Reference Therapy 
None 
Key Procedures 
None 

Study number: s22-01093
Page 2
Version: 6.0     Date: 04/15/2024 
 
 
CONFIDENTIAL 
This material is the property of the NYU Langone Health.  Do not disclose or use except as authorized in writing by the study 
sponsor 
Behavioral Intervention Template Version: 18 July 2022
Statistical Analysis 
Aim 1: Descriptive statistics to describe sample characteristics 
Aim 2: Descriptive statistics will be calculated to summarize caregiver 
characteristics, feasibility, acceptability, and app usability outcomes. Paired t-
tests will be performed to compare (1) changes in caregiver delirium 
knowledge and caregiving mastery from baseline to Week 2 (immediately 
post training), and (2) changes in delirium knowledge, caregiving mastery, 
strain, depression, and burden from baseline to posttest (Week 6).

Study number: s22-01093
Page 3
Version: 6.0     Date: 04/15/2024 
 
 
CONFIDENTIAL 
This material is the property of the NYU Langone Health.  Do not disclose or use except as authorized in writing by the study 
sponsor 
Behavioral Intervention Template Version: 18 July 2022
Schematic of Study Design
Figure 1. Aim 1 Codesign Workshop 
 

Study number: s22-01093
Page 4
Version: 6.0     Date: 04/15/2024 
 
 
CONFIDENTIAL 
This material is the property of the NYU Langone Health.  Do not disclose or use except as authorized in writing by the study 
sponsor 
Behavioral Intervention Template Version: 18 July 2022
Figure 2. Aim 2 Feasibility Trial 
 
 

Study number: s22-01093
Page 5
Version: 6.0     Date: 04/15/2024 
 
 
CONFIDENTIAL 
This material is the property of the NYU Langone Health.  Do not disclose or use except as authorized in writing by the study 
sponsor 
Behavioral Intervention Template Version: 18 July 2022
1
Key Roles
NYU 
PI/Contact PI/Study Coordinator: Shih-Yin Lin, PhD, MPH, MM 
NYU Rory Meyers College of Nursing 
433 First Avenue, #745M, New York, NY10010 
sl199@nyu.edu 
(720) 883-5715 (cell)
 
NYU Collaborator/Medical Monitor: Abraham A. Brody, PhD, RN, FPCN, FAAN 
NYU Rory Meyers College of Nursing/NYU Grossman School of Medicine 
433 First Ave, Room 504, New York, NY10010 
Ab.Brody@nyu.edu 
(212) 992-7341
 
NYU Collaborator/Statistician: Jason Fletcher, PhD 
NYU Rory Meyers College of Nursing 
433 First Ave, Room 753, New York, NY10010 
jason.fletcher@nyu.edu 
(212) 998-5401 
 
 
UNIVERSITY OF PITTSBURG 
Co-PI/Back Up Study Coordinator: Yong K. Choi, PhD, MPH 
Department of Health Information Management 
School of Health and Rehabilitation Science 
University of Pittsburgh 
6051B Forbes Tower, 3600 Atwood St, Pittsburgh, PA 15260 
yong.choi@pitt.edu 
(206) 496-2147 (cell) 
 
 
OTHER  
External Consultant – DSD expert: Donna M. Fick, PhD, RN, FAAN 
Penn State College of Nursing 
308 Nursing Sciences Building, University Park, PA 16802 
dmf21@psu.edu 
(814) 865-9325 
 
External Consultant – Geriatric Pharmacotherapy and Patient Education: Jennifer A Pruskowski, 
Pharm D, MS, BCPS, BCGP  
Assistant Professor and Director of Geriatric Pharmacy Research and Education 
Division of Geriatric Medicine, School of Medicine 
University of Pittsburgh 
jpruskow@pitt.edu 
(412) 692-2361 
Emory University Collaborator/Project Mentor: Drenna Waldrop, PhD 
Nell Hodgson Woodruff School of Nursing 
Emory University  
1520 Clifton Road,  

Study number: s22-01093
Page 6 
Version: 6.0     Date: 04/15/2024 
 
 
CONFIDENTIAL 
This material is the property of the NYU Langone Health.  Do not disclose or use except as authorized in writing by the study 
sponsor 
Behavioral Intervention Template Version: 18 July 2022
Atlanta, GA 30322 
drenna.waldrop@emory.edu 
(404) 712-9487
 
Study Sponsor: Emory Roybal Center for Dementia Caregiving Mastery/NIA 
[Emory University is the Primary Awardee of this NIA Grant.] 
Emory Roybal Center Contacts:  
 
Molly M. Perkins, PhD 
101 Woodruff Circle, Suite 1013 
Atlanta, GA 30322 
molly.m.perkins@emory.edu 
(404) 727-8676 
 
Kenneth Hepburn, PhD 
Nell Hodgson Woodruff School of Nursing 
1520 Clifton Road,  
Atlanta, GA 30322 
khepbur@emory.edu 
(404) 712-9286 
 
This proposal is selected by the Emory Roybal Center to receive funds (subaward) from the NIA grant 
 
Table 1. Roles and Responsibilities 
 
Name 
Address/ 
Phone/Email  
Role 
Responsibilities 
Shih-Yin Lin
NYU Rory Meyers 
College of Nursing 
433 First Ave #745M 
New York, NY 
10010 
(720) 883-5715 
(Cell) 
SL199@nyu.edu 
Principal investigator
(PI); Contact PI; 
Study coordinator
Identification, recruitment, screening, 
enrollment, and retention of participants
 Reporting and monitoring of adverse events 
and serious adverse events 
 Obtaining informed consent from participants 
 Compliance with and accountability of study 
intervention administration 
 Submitting required documents and reports 
to the NYU School of Medicine IRB, NIA, 
Safety Officer, and Emory Roybal Center   
 Development and implementation of data 
collection, management, and quality control 
procedures 
 Ensuring compliance with human subjects 
regulations and policies 
 Collection of study data and follow up of 
participants through study completion 
 Development and maintenance of all study 
materials including the MOP and study forms 
 Maintenance of study binder 
 Data analysis 
 Dissemination of study findings 
Coordination of study team meetings
Yong K. 
Choi 
Department of 
Health Information 
Management 
School of Health and 
Rehabilitation 
Sciences 
University of 
Pittsburgh 
Co-PI; Back-up 
study coordinator 
 Identification, recruitment, screening, 
obtaining consent, enrollment, and retention 
of participants  
 Scheduling and leading Aim 1 human-
centered co-design workshop  
 Development of personas, mHealth app 
prototypes, and other relevant study 
materials 

Study number: s22-01093
Page 7 
Version: 6.0     Date: 04/15/2024 
 
 
CONFIDENTIAL 
This material is the property of the NYU Langone Health.  Do not disclose or use except as authorized in writing by the study 
sponsor 
Behavioral Intervention Template Version: 18 July 2022
Name 
Address/ 
Phone/Email
Role 
Responsibilities 
6051B Forbes 
Tower, 3600 Atwood 
St, Pittsburgh, PA 
15260 
(206) 496-2147 
(Cell) 
yong.choi@pitt.edu
Collection of study data and follow-up of 
participants  
Data analysis
 Communication with the app developer 
 Preliminary usability testing  
 Dissemination of study findings 
Abraham A. 
Brody 
NYU Rory Meyers 
College of Nursing
433 First Ave, Room 
504, New York, 
NY10010 
(212) 992-7341 
Ab.Brody@nyu.edu 
NYU 
collaborator/Medical 
monitor to adjudicate 
for study-
relatedness of 
adverse events and 
series adverse 
events  
Assist with participant recruitment, review 
intervention materials, serve as the adjudicator to 
determine whether an adverse or serious 
adverse event is related to the study, assist with 
interpretation and dissemination of research 
findings.  
Jason 
Fletcher 
NYU Rory Meyers 
College of Nursing 
433 First Ave, Room 
753, New York, NY 
10010 
(212) 998-5401 
Jason.fletcher@nyu.
edu 
NYU 
collaborator/Statistici
an 
Dr. Fletcher will assist with quantitative data 
analysis, interpretation, and the 
writeups of quantitative findings.  
Donna M. 
Fick 
Penn State College 
of Nursing 
308 Nursing 
Sciences Building, 
University Park, PA 
16802 
(814) 865-9325 
dmf21@psu.edu 
External consultant 
– expert on delirium 
superimposed on 
dementia
Dr. Fick will participate in the scheduled quarterly 
study team meetings, review study materials, 
and be available for additional consultation as 
needed. Dr. Fick will assist the PIs in intervention 
development/adaptation; interpretation and 
dissemination of the research findings. She will 
not be engaged in research, as she will not 
interact with subjects or review identified data.  
Jennifer A 
Pruskowski, 
Pharm D, 
MS, BCPS, 
BCGP 
Assistant Professor 
and Director of 
Geriatric Pharmacy 
Research and 
Education 
Division of Geriatric 
Medicine, School of 
Medicine 
University of 
Pittsburgh 
(412) 692-2361 
jpruskow@pitt.edu 
External consultant 
– expert on geriatric 
pharmacotherapy 
and patient 
education 
Dr. Pruskowski will review intervention contents, 
focusing on guidance and patient education 
materials related to deprescribing of delirium-
inducing medications; respond to participants’ 
medication-related questions that arise 
throughout the study periods; and attend the 
study team meetings as needed. Dr. Pruskowski  
will also participate in publishing results of the 
study. She will not be engaged in research, as 
she will not interact with subjects or review 
identified data.
Drenna 
Waldrop 
Nell Hodgson 
Woodruff School of 
Nursing  
Emory University 
1520 Clifton Road, 
NE Atlanta, GA 
30322-4027 
(404) 712-9487 
drenna.waldrop@em
ory.edu 
Emory University 
collaborator/Project 
mentor 
Dr. Waldrop will provide mentorship to ensure 
successful completion of this project in 
accordance with NIA and Emory Roybal Center 
regulations and policies. Dr. Waldrop may also 
participate in publishing results of the study. She 
will not be engaged in research, as she will not 
interact with subjects or review identified data.  

Study number: s22-01093
Page 8
Version: 6.0     Date: 04/15/2024 
 
 
CONFIDENTIAL 
This material is the property of the NYU Langone Health.  Do not disclose or use except as authorized in writing by the study 
sponsor 
Behavioral Intervention Template Version: 18 July 2022
2
Introduction, Background Information and Scientific Rationale
2.1
Background Information and Relevant Literature 
Delirium Superimposed on Dementia (DSD) refers to occurrence of delirium (i.e., a serious, acute, 
fluctuating disturbance in attention and cognition) in persons living with dementia (PLWD).1 DSD is highly 
prevalent in PLWD, affecting 22% to 89% of PLWD in the community and hospital settings.1 Compared to 
dementia alone, those with DSD have accelerated cognitive and functional declines and higher rates of 
rehospitalization, institutionalization, and death.2–4 Moreover, DSD causes substantial distress and burden 
to both PLWD and family caregivers5,6—defined here as relatives and friends that provide unpaid care. 
 
Research shows that it is feasible for family members to perform delirium assessment to aid early 
detection7–12 and assist with delirium prevention and management tasks to address modifiable risk 
factors.13,14 The purpose of this project is to develop and pilot test a family-centered, mHealth-
enhanced intervention program to improve caregivers’ knowledge, skills, and mastery in DSD detection, 
prevention, and management in the community. The proposed intervention, the “Aliviado DSD Caregiving 
Mastery” program, will adapt existing DSD components in the clinician-focused, evidence-based “Aliviado 
Dementia Care” program for use by family caregivers.15–17 “Aliviado” means “relief” in 
Spanish/Portuguese. The original Aliviado Dementia Care program is an agency-wide quality 
improvement program to optimize home-based, clinician-delivered symptom management for PLWD and 
their families. The existing Aliviado DSD contents include a DSD education video for aides, a clinician-
initiated acute delirium care plan, a clinician-administered delirium assessment, and an acute delirium 
caregiver education article, all accessible via a clinician-facing Aliviado mHealth app. While these 
contents are a solid template for the proposed intervention, with the exception of the caregiver education 
article (written for both professional caregivers and family caregivers), the remaining DSD contents 
require adaptation for direct use by families. Moreover, to promote caregivers’ self-efficacy/mastery, we 
include additional strategies informed by Pearlin’s Stress Process Model,18 Bandura’s Social Cognitive 
Theory19–22 (e.g., social support and goal setting), and Nudge Theory.23 The proposed study aligns with 
Stage I of the NIH Stage Model.24
 
2.1.1 Theoretical Framework/Mechanism  
The DSD Caregiving Mastery Program is informed by the Stress Process Model, Social Cognitive Theory 
(including the Threefold Stepwise Implementation Model19), and Nudge Theory. In the Stress Process 
Model (Figure 3): The “primary stressors” are the patient’s cognitive status, problematic behaviors, and 
dependencies of activities of daily living, and the caregiver’s felt sense of overload and relational 
deprivation. The “secondary stressors” are role strains and intrapsychic strains including global mastery 
and situational competence. This intervention program is designed to address a specific type of 
situational comptenence, DSD caregiving mastery. The “mediators” are coping and social support.  
 
DSD accelerates cognitive and functional declines and can worsen behavioral issues, yet different from 
dementia, delirium is often preventable and reversible. Thus, the prevention and early detection tasks can 
help reduce the additional situational caregiving stress resulting from DSD-induced cognitive and 
functional declines and worse behavior symptoms at the “primary stressors” level. The inclusion of a 
caregiver strain assessment and referral to community supportive services as part of this 
intervention helps to address the “secondary role strains” in the Stress Process Model. The tailored 
care plan with specific DSD management strategies addresses the “mediator” of coping, while the ability 
to include a secondary caregiver helps to activate the “mediator” of social support. To address “secondary 
intrapsychic strains” in the Stress Process Model, we adopt Social Cognitive Theory-informed strategies 
to promote mastery and competence. For instance, training videos with successful case scenarios 
provide observational learning/vicarious experience, meanwhile increase caregivers’ DSD 
knowledge/skills to improve behavioral capabilities and competence. Practicing delirium assessment 
using case vignettes as part of the caregiver training provides caregivers with mastery experiences in 
DSD detection, which contributes to increased self-efficacy and mastery. The tailored care plan facilitates 
goal setting. The additional support to help caregivers with lower self-efficacy to set incremental goals 

Study number: s22-01093
Page 9
Version: 6.0     Date: 04/15/2024
CONFIDENTIAL
This material is the property of the NYU Langone Health.  Do not disclose or use except as authorized in writing by the study
sponsor
Behavioral Intervention Template Version: 18 July 2022
follows the guidance in Bandura’s Threefold Stepwise Implementation Model. Lastly, we use Nudge 
Theory-informed mobile push notifications or text messages to provide text-based verbal persuasion, and 
nudge caregivers to perform the target prevention, detection, and symptom management behaviors. (See 
6.1 and Table 2 for more detail.)
Figure 3. Screenshot of Pearline's Stress Process Model
According to the Stress Process Model, improved mastery and competence may contribute to improved 
caregiver outcomes such as improved depression and anxiety. Therefore, we decide to also measure 
caregiver depressive symptoms to find out whether improved DSD caregiving mastery and competence 
are related to improved depressive symptoms in caregiver participants as a group (on average). 
This study does not diagnose depression nor screen for positive depression cases. 
2.2
Rationale
Research shows that it is feasible for family members to perform delirium assessment to aid early
detection7–12 and assist with delirium prevention and management tasks to address modifiable risk 
factors.13,14 However, most delirium/DSD interventions involving families have been developed for 
hospital/institutional settings8,8,9,13,14,25,26 and have not considered different education/training needs of 
multiple caregivers within the same family. Moreover, although mHealth apps for dementia caregivers 
have burgeoned,27,28 no DSD interventions have leveraged mHealth-based behavioral economics 
nudges,23 or motivational messages and prompts, to reinforce family caregivers’ implementation of DSD 
prevention, detection, and management tasks in the community. Thus, there is a considerable gap 
between what is feasible and the available interventions to support family caregivers to provide DSD care 
in the community.
The duration of the caregiver education/training period in the proposed intervention, the Aliviado DSD 
Caregiving Mastery Program, is set at 2 weeks to allow caregivers plenty of time to complete the self-
paced training. The duration of the implementation period is set at 4 weeks to assess whether caregivers 

Study number: s22-01093
Page 10
Version: 6.0     Date: 04/15/2024 
 
 
CONFIDENTIAL 
This material is the property of the NYU Langone Health.  Do not disclose or use except as authorized in writing by the study 
sponsor 
Behavioral Intervention Template Version: 18 July 2022
can perform weekly screening in the mHealth app for at least several times without major issues. Findings 
from this pilot feasibility trial will reveal feasibility and acceptability of the proposed frequency of delirium 
assessment and intervention duration, which will inform further refinement of the Aliviado DSD Caregiving 
Mastery Program in preparation for a future efficacy trial. 
 
Given that this is a pilot study to assess feasibility, acceptability, and preliminary impact of the 
intervention on family caregivers, all caregiver participants will receive the intervention (a single-group, 
pre-post design). There are no control groups nor PLWD subjects in this pilot study. After feasibility and 
acceptability of the intervention are established in family caregivers, we will then add control groups and 
enroll PLWD-caregiver dyads in future efficacy and effectiveness trials of the Aliviado DSD Caregiving 
Mastery Program. 
2.3
Potential Risks & Benefits
2.3.1 Known Potential Risks 
This is a minimal risk study. The intervention itself is inherently not risky as it is a family-centered, 
psychoeducational training program on implementation of evidence-based best practices through an 
mHealth app to improve family caregivers’ mastery in performing DSD detection, prevention, and symptom 
management tasks. The greatest potential risks to family caregiver subjects are (1) a breach of 
confidentiality and (2) psychological distress.  
 
Though possible, we anticipate that a breach of confidentiality is unlikely to happen because personal 
identifiers will only be collected and stored in the password-protected REDCap electronic consent and 
HIPAA authorization form, in which only authorized study team members will have access to, whereas all 
the other study data will be deidentified and stored in a password-protected NYU Box folder, in which access 
will only be granted to appropriate study team members. NYU Box is the NYU WSQ Campus approved 
storage of high-risk data. 
When learning something new such as a new mHealth app, some caregivers can become frustrated or 
experience psychological distress. However, we believe psychological distress is unlikely to happen, 
because we will have tested our mHealth app to ensure user-friendliness. We will also proactively offer 
additional technical support/training sessions on how to use the study app via Aliviado Support Center 
(Aliviado.dsd.caregiving@nyu.edu) to caregivers who report a lower level of comfort with technology at 
enrollment (caregivers are free to decline this offer/additional support). If caregiver subjects experience 
psychological distress or become frustrated with the technology, they can contact Aliviado Support Center 
(Aliviado.dsd.caregiving@nyu.edu) for assistance. If participants do not feel comfortable answering 
depressive symptom questions or any questions in any of the study questionnaires, they have the option 
to select “prefer not to answer” as their response. Subjects may also experience psychological distress 
when answering questions about their depressive symptoms and will also have the option to select “prefer 
not to answer”.  
2.3.2 Risk of Use of Mobile Health Technology 
The study mHealth app will only be used to collect study data with IRB approval. Though breach of 
confidentiality or loss of privacy is possible, we anticipate that either is unlikely to happen because the 
mHealth app is NYU-housed with IT security approval for research sensitive data and is HIPAA compliant. 
Data will be collected directly from individual users from the app in an encrypted process where the app is 
run in a Heroku shield private dynos runtime environment and the data will be stored in a Postgres database 
housed within a Heroku shield private space encrypted and secured environment (same type of 
environment that runs the NYU Langone Heath instance of the EPIC haiku app). The app does not access 
the user’s camera or albums and does not track the user’s physical activities. Any risks associated are 
outlined in the informed consent, as follows: 
 
“The optional testing of the beta version of the mHealth app may also subject you to potential risks of breach 
of confidentiality and psychological distress. However, we anticipate that the likelihood of these potential 

Study number: s22-01093
Page 11
Version: 6.0     Date: 04/15/2024 
 
 
CONFIDENTIAL 
This material is the property of the NYU Langone Health.  Do not disclose or use except as authorized in writing by the study 
sponsor 
Behavioral Intervention Template Version: 18 July 2022
risks should be similar to participating in the main co-design workshop and should not exceed what you 
would expect from your normal day-to-day use of apps that you download from an app store.” (Aim 1) 
 
“The Aliviado mHealth app is HIPAA compliant. The use of the Aliviado mHealth app to collect study data 
is approved by the NYU Grossman School of Medicine. Any information that you enter the Aliviado mHealth 
app is considered research data. Your data will be de-identified and aggregated with data from other study 
participants before we perform data analysis. Your data will be processed in an encrypted process and 
stored within an encrypted and secured environment. Potential risks associated with the use of the study 
mHealth app include loss of privacy and breach of confidentiality; however, these potential risks would not 
exceed what you would expect from your normal day-to-day use of commercially available mobile health 
technology such as apps that you download from an App store.” (Aim 2) 
 
2.3.3 Risk of Use of Text Messaging 
SMS text messaging will serve as an alternative to mobile push notification to provide reminders, caregiving 
tips, and words of encouragement to the caregiver study participants. We will obtain consent from 
participants to send text messages and will include information of the following risks in the consent form: 
 
Text messages are not encrypted, posing a risk to confidentiality, as they can be intercepted or accessed 
by unauthorized parties, including mobile or cell phone carriers. The security for sensitive or personal 
information is less robust compared to encrypted emails or secured messaging services, making texts more 
susceptible to compromise. The reliability of text messages is dependent on mobile network carriers, and 
neither the research team nor carriers are liable for delays or failures in message delivery. Participants may 
incur charges from their mobile carriers for texts related to the study, and these costs are the participant's 
responsibility, not covered by the research institution. It's crucial to note that text messaging is not suitable 
for emergency communication; in emergencies, participants should contact emergency services directly.  
 
The link to the privacy policy of the SMS text messaging carrier will also be provided:  
https://www.slicktext.com/privacypolicy.php. 
2.3.4  Known Potential Benefits 
Caregiver participants may experience potential benefits of improved DSD knowledge and a sense of 
mastery in performing DSD prevention, detection, and management tasks. 
3 Objectives and Purpose 
3.1 Primary Objective
The primary objective of this study is to assess feasibility, acceptability, and app usability of the Aliviado 
DSD Caregiving Mastery Program in a sample of family caregiver of PLWD at risk of delirium.  
.  
3.2 Secondary Objectives (if applicable) 
The secondary objective is to examine the preliminary impact of the Aliviado DSD Caregiving Mastery 
Program on family caregivers’ delirium knowledge, caregiving mastery, strain, depression, and burden.  
4 Study Design and Endpoints 
4.1
Description of Study Design
We will conduct a 2-phase pilot study to develop (Aim 1) and pilot test (Aim 2) an mHealth-enhanced 
intervention program to promote family caregivers’ detection, prevention, and management of DSD in the 
community (the “Aliviado DSD Caregiving Mastery program”). The first phase (Aim 1/intervention 

Study number: s22-01093
Page 12
Version: 6.0     Date: 04/15/2024 
 
 
CONFIDENTIAL 
This material is the property of the NYU Langone Health.  Do not disclose or use except as authorized in writing by the study 
sponsor 
Behavioral Intervention Template Version: 18 July 2022
development) is a 5-week co-design workshop, in which, 8 family caregivers will attend weekly sessions to 
review the proposed intervention contents and iteratively redesign the user interface of the existing, 
clinician-facing Aliviado mHealth app to ensure caregiver friendliness. The caregiver version of the Aliviado 
mHealth app will be built in between study phases, over a 6-week period, including a 4 to 5-week sprint to 
revise the app user interface based on caregivers’ design preferences and another week of preliminary 
testing with 5-6 caregivers from the co-design workshop to ensure no major navigation issues or broken 
links before proceeding to the second phase of the study. The second phase of the study (Aim 2) is a 6-
week feasibility trial of the full mHealth-enhanced Aliviado DSD Caregiving Mastery program, in which, 30 
family caregivers will first complete DSD training over a 2-week period (Week 1-Week 2) and then 
implement a care plan of tailored DSD detection, prevention and management tasks including weekly 
delirium assessment in the caregiver mHealth app for another 4 weeks (Week 3-Week 6). The delirium 
assessment (Family Confusion Assessment Method7) has been developed and validated for use by 
families. This assessment asks family caregivers questions about the symptoms of their loved one over the 
past day/week/month based on their recall; no questions will be asked to the PLWD directly; no identifiers 
of the PLWD will be collected. The purpose of having caregiver subjects complete the weekly delirium 
assessment over this 4-week period (Week 3-Week 6) is to find out whether caregiver subjects can 
complete this assessment in the mHealth app successfully for several times on their own after watching the 
self-paced training videos during Week 1 and Week 2, revealing potential issues in completing this 
assessment, if any.The feasibility trial adopts a single-group, pre-post design. Caregiver participants will be 
enrolled to the feasibility trial on a rolling basis. Given that this is a feasibility study rather than an efficacy 
or effectiveness trial, there are no control groups and no PLWD subjects will be enrolled. Demographic 
information, dementia type/severity, comorbidity, and behavior symptoms of PLWD will be collected at 
baseline only, anonymously, to summarize the caregiving context of enrolled caregiver subjects. No 
PLWD outcome data will be collected in this study.   
4.2
Study Endpoints
4.2.1 Primary Study Endpoints 
Aim 1 co-design workshop: NA (The purpose of the co-design workshop is to understand caregiver 
participants’ preferences of the intervention contents and app features; no intervention is implemented at 
this stage and no outcome data collected.) 
 
Aim 2 feasibility trial: Because this is a pilot feasibility study instead of an efficacy or effectiveness trial, 
the primary study endpoints are feasibility, acceptability, and app usability: 
 
Feasibility is indicated by (1) successful enrollment of 30 primary caregivers and (2) 85% 
retention.  
 
Acceptability is indicated by: (1) >80% of primary caregiver participants reporting high program 
satisfaction and willingness to recommend this program to others; (2) >80% of primary caregiver 
participants completing all training videos within the target 2-week timeframe (Week 1-Week 2); 
and (3) >80% primary caregiver participants successfully complete the weekly delirium screening 
at least twice over the 4-week implementation period (Week 3-Week 6).  
 
App usability is assessed by a modified IBM Computer Usability Satisfaction Questionnaire17 at 
Week 6 (final visit).  
4.2.2 Secondary Study Endpoints 
Aim 1 co-design workshop: NA (The purpose of the co-design workshop is to understand caregiver 
participants’ preferences of the intervention contents and app features; no intervention is implemented 
and no outcome data collected at this stage.) 
 
Aim 2 feasibility trial: Secondary endpoints are caregivers’ delirium knowledge, caregiving mastery, strain, 
depression, and burden. Secondary endpoints are chosen to confirm the theoretical underpinning of the 
intervention and to provide evidence to support preliminary efficacy of the intervention.  

Study number: s22-01093
Page 13
Version: 6.0     Date: 04/15/2024 
 
 
CONFIDENTIAL 
This material is the property of the NYU Langone Health.  Do not disclose or use except as authorized in writing by the study 
sponsor 
Behavioral Intervention Template Version: 18 July 2022
4.2.3
Exploratory Endpoints
Aim 1 co-design workshop: NA (The purpose of the co-design workshop is to understand participants’ 
preferences; no intervention is implemented at this stage.) 
Aim 2 feasibility trial: If enough secondary caregivers are enrolled in the study, we will also explore 
changes in their delirium knowledge and caregiving mastery outcomes.  
5
Study Enrollment and Withdrawal
5.1
Inclusion Criteria 
Aim 1 co-design workshop: We will purposely sample 4 “dementia caregivers” and 4 “DSD caregivers”. 
DSD caregivers refer to dementia caregivers who have additional experience caring for a relative or friend 
during an episode of DSD. The inclusion of caregivers with varying levels of experience and familiarity 
with DSD will help ensure that we co-produce an mHealth-enhanced intervention that is applicable to 
caregivers of diverse DSD education/caregiving needs. 
 
a. To be eligible as a “dementia caregiver”, an individual must: 
 
be at least 18 years old,  
 
be English-speaking, 
 
provide at least 8 hours of unpaid care weekly or live with a community-dwelling PLWD, 
 
self-identify as unfamiliar with DSD, 
 
have the capacity to consent, and 
 
have Internet access 
 
b. To be eligible as a “DSD caregiver”, an individual must: 
 
be at least 18 years old, 
 
be English-speaking, 
 
be a current or past dementia caregiver with experience caring for a relative or friend during 
his/her DSD episode within the past 12 months, 
 
have the capacity to consent, and 
 
have Internet access. 
 
Aim 2 feasibility trial:  
To be eligible to participate in the feasibility trial, an individual must meet all of the following criteria: 
 
 
Being 18 years old or older, 
 
English-speaking, 
 
Providing at least 8 hours of unpaid care per week to, or living with, a community dwelling PLWD 
whose Delirium Risk Assessment Score >=5, 
 
Having the capacity to give informed consent, and 
 
Having a smartphone with Internet access. 
5.2
Exclusion Criteria
Aim 1 co-design workshop: Individuals who are blind or deaf will be excluded.  
Aim 2 feasibility trial: same as above.  
5.3
Vulnerable Subjects
NA. 

Study number: s22-01093
Page 14
Version: 6.0     Date: 04/15/2024 
 
 
CONFIDENTIAL 
This material is the property of the NYU Langone Health.  Do not disclose or use except as authorized in writing by the study 
sponsor 
Behavioral Intervention Template Version: 18 July 2022
5.4
Strategies for Recruitment and Retention
5.4.1 Use of DataCore/Epic Information for Recruitment Purposes 
This study will identify potentially eligible subjects in NYU Langone Health EPIC. The DataCore will pull a 
list of all potentially eligible primary caregivers of the following three patient groups: (1) individuals who 
have a diagnosis of dementia, (2) individuals who have had DSD, and (3) individuals who have a 
diagnosis of dementia and at risk for DSD (e.g., had recent hospitalization, age 75+, etc.). Dementia 
diagnoses and delirium diagnoses will be confirmed using ICD-10 codes. The study team will discard 
these lists within 3 business days after the recruitment goal is reached. No information of these lists will 
be retained by the study team. If the study team decides additional data pull is needed due to slow 
recruitment/no response from caregivers contacted, the study team will discard the older version of the list 
as soon as the study team receives a newer version. 
 
Up to three study recruitment messages will be sent via the MyChart online patient portal for the patient to 
share with their primary caregiver. If the phone number of the primary caregiver is available in EPIC, the 
study team will call the caregiver (up to three attempts) to follow up on potential study participation after 
sending the MyChart research message. Approved recruitment language will be used to communicate the 
reason of the call and the potential caregiver participant will be asked if they are interested in participating 
in this specific study. Should the potential caregiver subject agrees, the study team will provide the 
subject with information regarding the next steps for participation. Any personal identifiers of the PLWD 
will be discarded once caregivers have been recruited. No efforts will be made to relink this research data 
with PLWD 
 
Before sending the MyChart research message, if the patient has a primary care provider on file, the 
study team will notify the patient’s primary care provider that there are caregivers of their patients eligible 
to participate in this stduy using the IRB approved Aim 2 physician letter.  
 
If a subject requests information regarding opting out of further recruitment for all research, subjects will 
be directed to contact research-contact-optout@nyumc.org or 1-855-777-7858. 
5.4.2 Caregiver Self-Referrals 
It is possible that a potentially eligible caregiver learns about this study via public platforms (e.g., 
ClinicalTrials.gov, Alzheimer’s Association TrialMatch, etc.) or from another caregiver, and then, 
voluntarily calls or emails the PIs about study participation. When such self-referrals occur, the same 
screening/consenting procedures outlined in Section 7.3.1 in this study protocol will be followed.  
5.4.3 Family Caregiver Registry 
The study will leverage the regional family caregiver registry maintained by the University of Pittsburgh 
Center for Social & Urban Research (UCSUR) to identify potential study participants. This registry 
includes the names and contact information of unpaid family caregivers who have expressed interest in 
participating in research studies. UCSUR will send batches of recruitment emails to the family caregivers 
in the registry with a general study flyer and contact information. If interested, potential subjects will then 
directly contact the study team, and the same screening/consenting procedures outlined in Section 7.3.1 
in this study protocol will be followed. 
5.4.4 Clinician Referral 
Clinicians at the inpatient geriatrics consult service at NYU Langone’s Tisch Hospital / Kimmel Pavilion 
and Hospital - Brooklyn will distribute IRB-approved study flyers, as well as refer eligible caregivers who 
have expressed an interest in learning more about the study to the study team by emailing (1) the names 
of the caregiver and the patient and (2) the phone number of the caregiver to PI Lin in a secure email 
(SendSafe). PI Lin will verify this information against the geriatrics consult service’s patient list and 
monitor the patient’s discharge status. PI Lin will follow up with the caregiver about potential study 
participation only after the patient has been discharged. 

Study number: s22-01093
Page 15
Version: 6.0     Date: 04/15/2024 
 
 
CONFIDENTIAL 
This material is the property of the NYU Langone Health.  Do not disclose or use except as authorized in writing by the study 
sponsor 
Behavioral Intervention Template Version: 18 July 2022
5.4.5
Study Flyers (general), Facebook Recruitment, Recruitment Text Messages, and 
Information Sessions 
A general study flyer will be used to recruit caregivers from caregiver support groups, listservs, or 
professional organization member forums or special interest groups (e.g., the Gerontological Society of 
America). With permission from local senior centers or retirement communities, study flyers will also be 
posted on their bulletins.  
 
Study recruitment information will be provided to dementia organiziations/programs to distribute as 
Facebook posts if they have an organizational Facebook acocunt.  
If a memory/aging program uses text messaging as an existing method to communicate with their 
program subscribers, the study team will provide the memory/aging program with an IRB-approved 
recruitment text message to distribute to their subscribers.  
 
Interested caregivers will email Aliviado.dsd.caregiving@nyu.edu about study participation and the study 
team will perform screening to decide whether the caregiver is a dementia caregiver, a DSD caregiver, or 
a caregiver of an individual with dementia at risk of DSD.  
With permission from caregiver support groups, the study team will also host in-person or online 
information sessions about the study and collect contact information of interested caregivers.  
5.5 Duration of Study Participation
Aim 1 co-design workshop: Caregiver participants will be involved for approximately 6-8 weeks 
including screening, an enrollment visit, and participation in a 5-week co-design workshop. PLWD will not 
be enrolled. No PLWD will participate in the co-design workshop. All PLWD info will be based on 
caregiver report using an anonymous survey link sent to the caregiver subject at the end of the enrollment 
visit/before the first co-design session. 
 
Aim 2 feasibility trial: approximately 8-10 weeks for each caregiver participant, including screening, 
baseline/enrollment visit (Week 0), a 6-week intervention period, and a posttest visit. The enrollment of 
caregiver participants to the Aim 2 feasibility trial is on a rolling basis. PLWD will not participate in the 
feasibility trial. All PLWD info will be based on caregiver report using anonymous survey links sent to the 
caregiver subject at the end of the enrollment visit/before the start of the caregiver intervention. 
Anonymous PLWD data will be collected at baseline only. No outcome data of the PLWD will be 
collected.  
 
5.6
Total Number of Participants and Sites 
Aim 1 co-design workshop: n=8 to 16; collaborative research between 2 academic institutions. 
“Collaborative” means that each institution carries out part of the research activities. Recruitment will end 
after 8 caregiver participants are enrolled and a waitlist of another 8 eligible caregivers are identified. We 
plan to maintain a waitlist of eligible caregivers in case some enrolled caregiver participants decide to 
leave the study early or cannot attend some of the weekly group co-design sessions due to time conflicts 
or other reasons. Caregivers on the waitlist will be screened for eligibility before being listed on the 
waitlist. If any openings of the weekly co-design sessions are available, caregivers on the waitlist will be 
notified by phone or email from the research team. Before attending the co-design workshop, caregivers 
on the waitlist will need to provide eConsent in REDCap following the same standard procedure as the 
enrolled participants. The Aim 1 co-design workshop is collaborative research between two sites, i.e., 
NYU and the University of Pittsburg. The co-design workshop will be led by the co-PI at the University of 
Pittsburg via HIPAA Complaint Zoom while data collected from the co-design workshop will be stored in 
the password-protected NYU REDCap or NYU Box as appropriate. Caregiver subjects will be recruited 
from a list of potentially eligible caregivers identified in the data pull performed by the DataCore. The 
screening and consenting of all caregiver subjects will be completed by the PI or the co-PI following the 
“Remote e-Consenting” process using “REDCap” described in the “Use of Electronic Informed Consent” 

Study number: s22-01093
Page 16
Version: 6.0     Date: 04/15/2024 
 
 
CONFIDENTIAL 
This material is the property of the NYU Langone Health.  Do not disclose or use except as authorized in writing by the study 
sponsor 
Behavioral Intervention Template Version: 18 July 2022
guidance document. We will create the REDCap version of the IRB-approved consent form following the 
NYU Health Science Library video series on eConsent. 
Aim 2 feasibility trial: n=30 to 60 (30 primary caregivers + 0-30 optional secondary caregivers); single site.  
The enrollment goal is 30 primary caregiver participants. The 30 enrolled primary caregivers are allowed 
to invite additional family members or friends to participate in the study and enroll as secondary 
caregivers. However, the enrollment of secondary caregivers is optional, and thus, we anticipate 0 to 30 
secondary caregivers will be enrolled. To ensure the study is adequately powered, we need 26 evaluable 
primary caregiver participants who complete the study. We will recruit additional primary caregivers if 
more than 4 primary caregivers drop out of the study, or the number of primary caregiver participants who 
complete the study has not reached 26. Single site: All participants will be screened, enrolled, and 
consented at the NYU Site; all data will be collected and stored in the password-protected NYU REDCap 
or NYU Box as appropriate. Data will be deidentified before uploading to NYU Box. Subjects will be 
recruited from a list of potentially eligible caregivers identified in the data pull performed by the DataCore. 
The screening and consenting of all caregiver subjects will be completed by the PI or an NYU research 
assistant trained by the PI following the “Remote e-Consenting” process using “REDCap” as described in 
the “Use of Electronic Informed Consent” guidance document. We will create the REDCap version of the 
IRB-approved consent form following the NYU Health Science Library video series on eConsent.
5.7
Participant Withdrawal or Termination
5.7.1 Reasons for Withdrawal or Termination 
Participants are free to withdraw from participation in the study at any time upon request. An investigator 
may terminate participation in the study if: 
 
Any clinical adverse event (AE), laboratory abnormality, or other medical condition or situation 
occurs such that continued participation in the study would not be in the best interest of the 
participant 
 
The participant meets an exclusion criterion (either newly developed or not previously 
recognized) that precludes further study participation
5.7.2 Handling of Participant Withdrawals or Termination 
The study team will ask participants to provide their reason(s) for termination and keep a 
termination log. The study team will email and call the participants for up to three times to obtain their 
reason(s) for termination; for Aim 2 participants, the study team will also ask participants to provide 
information on any adverse events/serious adverse events suspected/experienced during their study 
participation (this is not applicable to Aim 1 participants because Aim 1 is not an intervention study). To 
reduce the likelihood of participant withdrawals, the study team will clearly explain to potential caregiver 
participants the study procedures during screening and the consenting process, ensure accuracy of contact 
information of enrolled caregiver participants, query about any plans to move within the next 6 months, and 
allow flexibility in scheduling data collection sessions (i.e., scheduling the Aim 1 weekly codesign sessions 
to the day of the week most participants are availability; allowing +/- 5 days to complete each Aim 2 planned 
data collection session). Caregiver participants will be encouraged to contact the Aliviado Support Center 
at Aliviado.dsd.caregiving@nyu.edu for any questions, concerns, or technical support; questions and 
concerns about the study will be forwarded to the PIs; technical support will be provided by the Support 
Center staff.   
For Aim 1 codesign workshop, we plan to maintain a waitlist of 8 caregivers in case some of the enrolled 
caregivers drop out of the study or are not able to complete all 5 weekly codesign sessions. Caregivers on 
the waitlist will be notified of openings of the weekly codesign sessions and will need to complete the 
standard eConsent procedure in order to attend the codesign sessions. 
For Aim 2 feasibility trial, if there are more than 4 dropouts, we will continue to recruit additional caregivers 
until 26 primary caregivers have completed the study.  

Study number: s22-01093
Page 17
Version: 6.0     Date: 04/15/2024 
 
 
CONFIDENTIAL 
This material is the property of the NYU Langone Health.  Do not disclose or use except as authorized in writing by the study 
sponsor 
Behavioral Intervention Template Version: 18 July 2022
5.7.3
Premature Termination or Suspension of Study
This study may be temporarily suspended or prematurely terminated if there is sufficient reasonable 
cause. Written notification, documenting the reason for study suspension or termination, will be provided 
by the suspending or terminating party to all investigators, the funding agency, and regulatory authorities. 
If the study is prematurely terminated or suspended, the PI will promptly inform the IRB and will provide 
the reason(s) for the termination or suspension. 
Circumstances that may warrant termination or suspension include, but are not limited to: 
 
Determination of unexpected, significant, or unacceptable risk to participants 
 
Demonstration of efficacy that would warrant stopping 
 
Insufficient compliance to protocol requirements 
 
Data that are not sufficiently complete and/or evaluable 
 
Determination of futility 
 
Study may resume once concerns about safety, protocol compliance, data quality are addressed and 
satisfy the sponsor and/or IRB. 
6 Behavioral/Social Intervention 
6.1
Study Behavioral or Social Intervention(s) Description
The Aliviado DSD Caregiving Mastery Program is an mHealth based family caregiver intervention to 
promote prevention, detection, and management of DSD in the community. The DSD Caregiving Mastery 
program consists of training videos; symptom management algorithms; assessments; care plans; 
education articles; mobile push notification or text message reminders and encouragements; and brief 
communication guides to empower/activate caregivers to discuss probable DSD and deprescribing of 
delirium-inducing medications with their loved one’s healthcare providers. The communication guides are 
provided to caregiver subjects when they obtain a positive result using the Family Confusion Assessment 
Method, or when a delirium-inducing medication is identified according to the 2023 updated Beers criteria 
in the medication list that they provided. Caregivers will be instructed to use these guides to speak with 
their loved one’s health care provider. The training videos will cover the purpose of theses guides, how to 
use theses guides, the role of family caregiver in delirium prevention, and how to peform the Family 
Confusion Assessment Method. Their loved one’s healthcare provider will be the one to confirm or rule 
out delirium based on his/her clinical assessment, as well as make recommendations about what to do 
with the specific delirium-inducing medication based on his/her clinical judgement (continue, stop, reduce 
dosage, etc.). See Attachment A for the existing delirium-related contents from the existing Alivaido 
Dementia Care program to be adapted for use by family caregivers. See Box 1 for topics of the training 
videos to be developed.  
 
Table 2. Topics Covered in the DSD Training Videos for Family Caregivers  
 
Existing Topics in the aide training video (will be 
shown to the family caregivers in Aim 1 codesign 
workshop as an example to elicit feedback on how 
to redesign the video for use by family caregivers)
New topics to be added to the family caregiver 
version of the training videos (informed by 
literature review) 
 
What is delirium?
 
Symptoms of delirium 
 
Delirium vs dementia 
 
Delirium vs sundowning 
 
Common causes of delirium 
 
Link to the existing aide training video. 
 
Important role families play in DSD care (
 
Assess delirium using Family Confusion 
Assessment Method (FAM-CAM)  
 
3 case vignettes to practice delirium 
assessment using FAM-CAM  
 
Daily prevention/management  
 
Prevention/management task while your loved 
one is hospitalized  
 
Discuss probable DSD/de-prescribing using 
the tailored communication guides  

Study number: s22-01093
Page 18
Version: 6.0     Date: 04/15/2024 
 
 
CONFIDENTIAL 
This material is the property of the NYU Langone Health.  Do not disclose or use except as authorized in writing by the study 
sponsor 
Behavioral Intervention Template Version: 18 July 2022
 
 
Because the objective of the Aim 2 feasibility trial is to assess feasibility and acceptability of the 
intervention in family caregivers instead of efficacy or effectiveness of the intervention, there is no control 
intervention/treatment. No PLWD will be enrolled. No outcome data of PLWD will be collected. 
Information of PLWD will only be collected at baseline based on caregiver report in anonymous survey 
questionnaires (no personal identifiers of PLWD being collected).  
6.1.1
Administration of Intervention
Caregivers will first complete self-paced training videos (~60 minutes total) over a 2-week period, followed 
by a 4-week usability testing period in which caregivers will administer an app version of the Family 
Confusion Assessment Method weekly (~5 minutes/week), perform daily prevention or management 
tasks specified in a tailored, caregiver-developed care plan, and receive weekly push notification 
reminders and encouragements. In cases where push notifications are not feasible or cannot be 
delivered, SMS text messaging will serve as an alternative method to convey motivational messages. 
This approach ensures that the motification messages related to the research study can still be reliably 
conveyed to participants. The DSD management algorithm identified in the literature will be simplified and 
presented as a series of questions to caregivers to guide tailoring of the care plan.  
Caregivers can choose to complete the training videos in the mHealth app or on the Aliviado website. 
Caregivers will learn how to administer the Family Confusion Assessment Method through watching the 
self-paced training videos. 
All caregivers will receive a user manual that provides (1) instructions on how to complete the 
training/navigate the app; and (2) a log to record questions and daily tasks completed. If a delirium 
assessment is positive, a tailored communication guide will be provided to facilitate caregivers’ discussion 
of probable DSD with a healthcare provider. If delirium-inducing medications are identified, a tailored 
communication guide will be generated to facilitate the discussion on de-prescribing.  
At enrollment, caregiver’s health literacy, caregiving self-efficacy, and comfort with technology will 
be assessed using the BRIEF Health Literacy Screening, the Revised Scale for Caregiving Self-Efficacy 
and the Functional Assessment of Comfort Employing Technology Scale to tailor additional support to 
caregivers (caregivers can decline this offer). For instance, weekly check-in calls will be offered to 
caregivers with low health literacy over the 2-week training period to ensure understanding of the training 
material using the teach back method. For caregivers with low self-efficacy, the PI will offer a 1:1 call at 
the end of the 2-week training period to help caregivers set incremental goals to carry out the care plan. 
At enrollment, caregivers will also complete the Modified Caregiver Strain Index. Those who score >=7 
will be offered referral to external support services such as NYU Alzheimer’s Caregiving Program.  
All caregivers can contact the NYU Meyers Aliviado Support Center for technical support; 
questions on how to perform assessments or specific care plan tasks will be forwarded to the PI. 
Caregivers’ usage of the tailored additional support and the Support Center will be recorded and counted 
towards intervention dosage. 
6.1.2 Procedures for Training Interventionalists and Monitoring Intervention Fidelity 
The PI and the Aliviado Support Center will facilitate caregiver subjects’ accessing the intervention. 
Intervention fidelity will be assessed through automatically tracking caregivers’ completion of the self-
paced training videos and Family Confusion Assessment Methods in the mHealth app. Fidelity of 
implementation of daily DSD prevention/management tasks will be assessed through reviewing 
caregivers’ task completion log (available in the user manual provided to the caregiver).   
6.1.3 Assessment of Subject Compliance with Study Intervention 
Caregivers’ compliance with study intervention will be assessed through reviewing caregivers’ daily task 
completion log during the 3rd and final data collection session.  
 

Study number: s22-01093
Page 19
Version: 6.0     Date: 04/15/2024 
 
 
CONFIDENTIAL 
This material is the property of the NYU Langone Health.  Do not disclose or use except as authorized in writing by the study 
sponsor 
Behavioral Intervention Template Version: 18 July 2022
7
Study Procedures and Schedule
7.1
Study Procedures/Evaluations
7.1.1
Study Specific Procedures
Aim 1: Codesign Workshop
Screening/Informed Consent 
 
Screen potential subjects by inclusion and exclusion criteria until 8 family caregivers are consented 
(via HIPAA-compliant Zoom) and formally enrolled in the study and an additional 8 family caregivers 
meeting the inclusion/exclusion criteria are identified and recorded in a waitlist.  
 
Baseline/enrollment data collection 
 
One 1:1 data collection session will be scheduled and completed with each co-design workshop 
participant at baseline/enrollment. This can be completed during the Zoom call to obtain informed 
consent with the caregiver participant’s agreement or scheduled at a later time.  
 
 
5-Week Codesign workshop 
Caregiver participants will attend 5 weekly group co-design sessions (90-120 minutes/session) to discuss 
the following topics:  
 
Session 1: family education videos 
 
Session 2: assessments and care plans 
 
Session 3: caregiver education articles and communication guides 
 
Session 4: mobile push notification or text messages to motivate/encourage caregivers 
 
Session 5: final design and features of the mHealth app; ways to best engage other family 
members in delirium care 
Sample materials to show caregiver subjects in the co-design sessions are provided in Attachment A.  
 
Optional User Testing: An optional 30-minute, 1:1 user testing session will be scheduled with 5-6 
volunteers from Aim 1 participants and waitlist on a first come first serve basis to test the beta version of 
the new caregiver mHealth app developed based on co-design workshop feedback before starting the Aim 
2 pilot feasibility trial.  
 
Aim 2: Pilot Feasibility Trial 
Screening/Informed Consent 
 
Screen potential subjects by inclusion and exclusion criteria until 30 primary caregivers are 
consented and formally enrolled in the study 

Study number: s22-01093
Page 20
Version: 6.0     Date: 04/15/2024 
 
 
CONFIDENTIAL 
This material is the property of the NYU Langone Health.  Do not disclose or use except as authorized in writing by the study 
sponsor 
Behavioral Intervention Template Version: 18 July 2022
o 
Optional: enrolled caregivers (“primary caregivers”) can choose to invite additional relatives 
or friends to join the study as “secondary caregivers”, who will also need to meet the 
inclusion/exclusion criteria and provide informed consent to participate in the study 
 
Obtain informed consent: n=30 primary caregivers + up to 30 secondary caregivers  
 
Week 0 Baseline/Enrollment Visit, n=30 primary caregivers + up to 30 secondary caregivers 
 
Collect baseline caregiver demographics, health literacy, caregiving self-efficacy, comfort with 
technology, strain, *depressive symptoms, burden, delirium knowledge, and DSD caregiving 
mastery in an online survey questionnaire in REDCap; all information being collected is based on 
caregiver report.   
 
Collect caregiver reported PLWD demographics, dementia type/severity, comorbidity, behavioral 
symptoms, and medications using anonymous (no PLWD identifiers being collected in this study) 
online survey questionnaires in REDCap.  
 
Week 1-Week 2 Intervention – Caregiver Education: n=30 primary caregivers + up to 30 secondary 
caregivers 
 
Caregivers complete self-paced educational videos on DSD and how to administer a brief 
delirium screener, the Family Confusion Assessment Method  
 
Week 2 Visit (Immediately Post Training): n=30 primary caregivers + up to 30 secondary caregivers 
 
Collect data on caregiver participants’ delirium knowledge and DSD caregiving mastery in an online 
REDCap survey questionnaire.  
 
Week 3-Week 6 Intervention Implementation: n=30 primary caregivers + up to 30 secondary caregivers  
 
Caregivers complete weekly delirium screening using the Family Confusion Assessment Method 
in the study mHealth app.  
 
Caregivers implement a care plan consisting of delirium prevention or management tasks tailored 
to their loved one’s delirium risk factors. 
 
Week 6 Final Visit (n=30 primary caregivers + up to 30 secondary caregivers) 
 
Collect data on caregiver participants’ delirium knowledge, DSD caregiving mastery, caregiver 
strain, depressive symptoms, burden, program satisfaction, and app usability in an online REDCap 
survey questionnaire. 
 
Also see Attachment C for schedule of events.  
 
*We will stick with CES-D to collect data on depressive symptoms. We were considering replacing it with 
PHQ-9 because PHQ-9 is a shorter questionnaire. We decided to still use CES-D because it does not ask 
about suicidal ideation. All de-identified baseline caregiver depressive symptom raw scores will only be 
analyzed as a group and presented as mean/sd/range (or median/interquartile range/range if not 
normality distributed).  
 
If a high level of symptoms are found from CES-D, such as depressive symptoms, we will offer to refer 
subjects to support services that may help with these, such as the NYU Alzheimer’s Caregiving Program. 
This information will remain confidential and will not be shared with others. 

Study number: s22-01093
Page 21
Version: 6.0     Date: 04/15/2024 
 
 
CONFIDENTIAL 
This material is the property of the NYU Langone Health.  Do not disclose or use except as authorized in writing by the study 
sponsor 
Behavioral Intervention Template Version: 18 July 2022
 
If a high level of caregiving strain is found, we will offer to refer subjects to support services that may help, 
such as the NYU Alzheimer’s Caregiving Program, however this information will remain confidential and 
will not shared with others. If the depressive symptom score has increased for 15 or more points from the 
baseline/enrollment visit for a subject, our medical monitor, Dr. Brody,  (a board-certified nurse 
practitioner) will call the subjects to better understand thier change in depressive symptoms; determine 
whether it is related to their study participation; and will refer them to mental health or emergency services 
as needed.  
 
Rationale for change score: We will calculate the mean and range of the change score 
from baseline to posttest as a group (=all caregivers’ scores lumped together).  
 
If the upper limit of the range of the group change score is below 15, then it means that no 
one in the group has a substantial increase in their depression score and we will not reach 
out to any participants about their depressive symptoms.  
 
If the upper limit of the range of the group change score is 15 or above (out of the 60-point 
CES-D scale), we will look up the participants who have a change score >=15 and notify the 
medical monitor.  
 
We only care about the change score because for people who have both high baseline and 
high posttest scores, it just shows that their baseline symptoms have not gotten better or 
worse over the study period.  
 
7.1.2 Standard of Care Study Procedures 
Not applicable. 
7.2
Laboratory Procedures/Evaluations 
Not applicable. 
7.2.1 Clinical Laboratory Evaluations 
Not applicable.  
7.2.2 Other Assays or Procedures 
Not applicable. 
7.2.3
Specimen Preparation, Handling, and Storage
Not applicable.  
7.2.4 Specimen Shipment 
Not applicable.  
7.3
Study Schedule
All visits will be completed through phone or Via HIPAA-Compliant Zoom.  
7.3.1 Screening 
I. 
Pre-Screening Phase 
a. Potential participants will call or email the PIs using the contact information provided in the 
recruitment email or mail.  
b. PIs will take the participant’s phone call or reply to the inquiry email and explain the study and 
answer questions. If a potential participant is interested and wishes to proceed, PIs will set up 
a formal screening appointment with the potential participant.  

Study number: s22-01093
Page 22
Version: 6.0     Date: 04/15/2024 
 
 
CONFIDENTIAL 
This material is the property of the NYU Langone Health.  Do not disclose or use except as authorized in writing by the study 
sponsor 
Behavioral Intervention Template Version: 18 July 2022
c. If the potential participant leaves a message, PIs will return their call and explain the study 
and answer questions within 2 business days. If the potential participant is interested and 
wishes to proceed, PIs will set up a formal screening appointment with the potential 
participant. 
d. A research assistant-trained by the PI will call potential participants referred by clinicians and 
caregivers who do not respond to email nor mail to tell them about the study using the IRB-
approved phone script and ask screening questions. The name of the interested and 
potentially eligible participants will be given to the PIs. PIs will then set up a formal screening 
appointment with each potential participant. The research assistant will send the informed 
consent materials electronically to the potential participant through SendSafe/REDCap to 
review. 
  
II. 
Screening Phase 
a. PIs will meet with the potential participant over the phone to explain the study procedures and 
answer questions. 
b. PIs will begin the process of ensuring that participant meets eligibility criteria as outlined in 
Section 5.1. The Sour Seven questionnaire will be used to help determine whether a 
caregiver is a “dementia caregiver” or a “DSD caregiver” if a potential caregiver participant is 
unsure whether or not their loved one has had DSD within the past 12 months (“We are 
looking for two types of caregivers of persons with dementia. To help us better decide which 
category you would fit the best, we are going to ask you some additional screening questions. 
Thinking of the past 12 months, was there a change in your loved one's health status, such 
as hospitalization or a new infection? If so, do you recall observation of any of the following, 
right before, during, or after the hospitalization or the infection: "). 
c. PIs will probe for participant’s ability to complete the duration of the study. These questions 
are used as indicators of potential early study dropouts. Potential caregiver participants’ 
response to these quesionts will not be used to exclude them from study participation.  
i. Is the participant planning to move within the next 6 months? 
ii. Is the participant looking for a new job? 
iii. Is the participant in the military, and/or do they have a spouse in the military? 
 
III. 
Consenting Phase 
a. If the caregiver is eligible and wishes to participate, PIs will then schedule a follow-up Zoom 
call with the caregiver within a week to complete the e-Consenting process together in 
REDCap. If the caregiver has not received a copy of the consent form from the research 
assistant, then PIs will email or mail a copy of the consent form to the potential caregiver 
participant in advance based on the caregiver’s preference. Eligible caregivers can also 
choose to proceed to complete the e-Consenting process described below within the same 
Zoom call.  
b. During the Zoom call (HIPAA compliant Zoom), PIs will open a new REDCap e-consent form 
in REDCap, share the screen and go over the IRB-approved REDCap e-consent and HIPAA 
authorization form, page by page, with the caregiver. The eConsent link will be provided as 
soon as available for IRB review and before use with caregiver subjects. The e-consent 
process informs the potential caregiver participant about the study, describes potential risks 
and benefits, indicates that the participation is voluntary and that he/she has the right to stop 
at any time. The PIs will also provide the potential caregiver participant contact information in 
case of medical emergency due to study participation and questions about subject rights, as 
well as explain who have access to study data and protected health information (PHI), how 
confidentiality is maintained, how the participant may receive the outcome of the study and 
incentives for study participation. The PI consenting the caregiver will ensure that the eligible 
caregiver has the opportunity to consider whether to participate and ask questions before 
electronically signing the consent and HIPAA authorization forms in REDCap during the 
Zoom call, as well as at anytime during their involvement in the research study.  
 

Study number: s22-01093
Page 23
Version: 6.0     Date: 04/15/2024 
 
 
CONFIDENTIAL 
This material is the property of the NYU Langone Health.  Do not disclose or use except as authorized in writing by the study 
sponsor 
Behavioral Intervention Template Version: 18 July 2022
If the caregiver decides to give consent, the PI consenting the caregiver will give the caregiver remote 
control over his/her mouse in his/her device to initial and sign the REDCap e-consent and HIPAA 
authorization form in REDCap. After signing electronically, the caregiver will receive an electronic copy of 
the signed consent and HIPAA authorization form immediately in an automatically generated email from 
REDCap. If a caregiver has difficulty signing the e-Consent form in REDCap using the PI’s mouse via 
remote control, the PI will email the caregiver a link to the REDCap e-Consent form and have the 
caregiver open the consent form in their local device (computer, laptop, etc.) to initial and sign in 
REDCap. Caregivers enrolled in the feasibility study phase will have the option to include additional 
secondary caregivers, who will undergo the same e-Consenting process. 
7.3.2
Enrollment/Baseline
Aim 1 codesign workshop: One 1:1 data collection visit will be scheduled and completed with each 
participant at baseline/enrollment (Week 0). The enrollment/baseline visit will be scheduled within 7 days 
from the time of informed consent. Participants can choose to complete the baseline/enrollment data 
collection in the same Zoom call in which they complete the eConsent. The following information will be 
collected in online REDCap survey qustionnaires:  
 
 Demographics  
 Familiarity with DSD 
 Health literacy 
 Comfort with technology 
 
Aim 2 feasibility trial: One 1:1 data collection visit will be scheduled and completed with each participant 
at baseline/enrollment (Week 0). The enrollment/baseline visit will be scheduled after the informed 
consent has been obtained and based on the participant’s availability. Participants can choose to 
complete the baseline/enrollment data collection in the same Zoom call in which they complete the 
eConsent. The following information will be collected in online REDCap survey questionnaires:  
 Demographics  
 Dementia severity 
 Behavioral symptoms 
 Health literacy  
 Caregiving self-efficacy 
 Comfort with technology 
 Strain 
 Depression 
 Burden 
 Delirium knowledge 
 DSD caregiver mastery 
7.3.3 Intermediate Visits 
Aim 1 codesign workshop: Caregiver participants will attend 5 weekly group co-design sessions (90-120 
minutes/session) to discuss the following topics. The first group co-design session will be scheduled within 

Study number: s22-01093
Page 24
Version: 6.0     Date: 04/15/2024 
 
 
CONFIDENTIAL 
This material is the property of the NYU Langone Health.  Do not disclose or use except as authorized in writing by the study 
sponsor 
Behavioral Intervention Template Version: 18 July 2022
a week after 8 participants have completed their baseline/enrollment visit. Each session will be video 
recorded along with live chat via HIPAA Compliaint Zoom.   
 
Session 1: family education videos  
 
Session 2: assessments and care plans 
 
Session 3: caregiver education articles and communication guides 
 
Session 4: mobile push notification or text messages to motivate/encourage caregivers 
 
Session 5: final design and features of the mHealth app; ways to best engage other family 
members in delirium care 
 
Aim 2 feasibility trial: The second 1:1 study visit will be scheduled in Week 2 (+/-5 days) to assess changes 
in delirium knowledge and DSD caregiving mastery immediately after each participant has completed the 
self-paced training videos on DSD in online REDCap survey questionnaires.  
7.3.4 Final Study Visit 
Aim 1 codesign workshop: See 7.3.3 above for information about the fifth co-design session. An optional 
30-minute, 1:1 user testing session will be scheduled with 5-6 volunteers from Aim 1 participants and waitlist 
to test the beta version of the new caregiver mHealth app developed based on co-design workshop 
feedback in-between the 2 study phases. The fifth co-design session and the 1:1 session will both be video 
recorded along with live chat via HIPAA Compliaint Zoom.   
Aim 2 feasibility trial: The final 1:1 study visit will be scheduled in Week 6 (+/-5 days) to collect data on the 
following using online REDCap survey questionnaires:  
 Caregiver strain 
 Depression 
 Caregiver burden 
 Caregiver delirium knowledge 
 DSD caregiver mastery 
 Program satisfaction 
 App usability 
 
7.3.5 Withdrawal Visit 
The PI or co-PI will email the subject up to 3 times and call the subject up to 3 times to obtain the 
reason(s) for the voluntary withdrawal. For Aim 2 participants, information on adverse events/serious 
adverse events suspected or experienced during their study participation will also be collected at this 
time. Reporting of adverse events/serious adverse events is not applicable to Aim 1 participants because 
the Aim 1 codesign workshop is not an interventional study.  
7.3.6 Unscheduled Visit 
For the Aim 1 co-design workshop, a group attendance sheet will be maintained to log attendance of the 
five weekly codesign sessions, along with reasons for absence. A group co-design session will be 
rescheduled, or a makeup session will be provided, if most of the participants are not able to attend a 
particular scheduled group co-design session.   
 
For the Aim 2 feasibility trial, data collection must be completed within +/- 5 days of each planned data 
collection session. Reasons for incomplete sessions will be documented in REDCap.  

Study number: s22-01093
Page 25
Version: 6.0     Date: 04/15/2024 
 
 
CONFIDENTIAL 
This material is the property of the NYU Langone Health.  Do not disclose or use except as authorized in writing by the study 
sponsor 
Behavioral Intervention Template Version: 18 July 2022
7.4
Concomitant Medications, Treatments, and Procedures
Not applicable.  
7.5
Justification for Sensitive Procedures
Not applicable. 
7.5.1
Precautionary Medications, Treatments, and Procedures
Not applicable.  
7.6
Prohibited Medications, Treatments, and Procedures
Not applicable.  
7.7
Prophylactic Medications, Treatments, and Procedures 
Not applicable.  
7.8
Participant Access to Study Intervention at Study Closure
Not applicable.  
8 Assessment of Safety 
8.1
Specification of Safety Parameters
The following sections are only applicable to the Aim 2 feasibility trial because the Aim 1 codesign 
workshop is not an interventional study.  
8.1.1 Definition of Adverse Events (AE) 
An adverse event (AE) is any symptom, sign, illness or experience that develops or worsens in severity 
during the course of the study.  In this minimal risk study, the sole anticipated potential AE is breach of 
confidentiality and will be monitored for. 
8.1.2 Definition of Serious Adverse Events (SAE) 
Serious Adverse Event 
Adverse events are classified as serious or non-serious.  A serious adverse event is any AE that is:  
 fatal 
 life-threatening 
 requires or prolongs hospital stay 
 results in persistent or significant disability or incapacity 
 a congenital anomaly or birth defect 
 an important medical event 
 
Important medical events are those that may not be immediately life threatening, but are clearly of major 
clinical significance. They may jeopardize the subject, and may require intervention to prevent one of the 
other serious outcomes noted above.  For example, drug overdose or abuse, a seizure that did not result 
in in-patient hospitalization, or intensive treatment of bronchospasm in an emergency department would 
typically be considered serious.  
 
All adverse events that do not meet any of the criteria for serious should be regarded as non-serious 
adverse events.  

Study number: s22-01093
Page 26
Version: 6.0     Date: 04/15/2024 
 
 
CONFIDENTIAL 
This material is the property of the NYU Langone Health.  Do not disclose or use except as authorized in writing by the study 
sponsor 
Behavioral Intervention Template Version: 18 July 2022
8.1.3
Definition of Unanticipated Problems (UP)
Unanticipated Problems Involving Risk to Subjects or Others 
Any incident, experience, or outcome that meets all of the following criteria:  
Unexpected in nature, severity, or frequency (i.e. not described in study-related documents such 
as the IRB-approved protocol or consent form, the investigators brochure, etc) 
 Related or possibly related to participation in the research (i.e. possibly related means there is a 
reasonable possibility that the incident experience, or outcome may have been caused by the 
procedures involved in the research) 
 Suggests that the research places subjects or others at greater risk of harm (including physical, 
psychological, economic, or social harm). 
8.2
Classification of an Adverse Event 
8.2.1 Severity of Event 
The following guidelines will be used to describe severity of adverse events. 
 
 Mild – Events require minimal or no treatment and do not interfere with the participant’s daily 
activities. 
 Moderate – Events result in a low level of inconvenience or concern with the therapeutic 
measures. Moderate events may cause some interference with functioning. 
 Severe – Events interrupt a participant’s usual daily activity and may require systemic drug 
therapy or other treatment. Severe events are usually potentially life-threatening or incapacitating. 
 
8.2.2 Relationship to Study Intervention 
The medical monitor’s assessment of an AE's relationship to study intervention is part of the 
documentation process, but it is not a factor in determining what is or is not reported in the study. If there 
is any doubt as to whether a clinical observation is an AE, the event should be reported. All AEs must 
have their relationship to study intervention assessed. In a clinical trial, the study intervention must always 
be suspect. To help assess, the following guidelines are used. Dr. Abraham Brody will adjudicate the 
relatedness of AEs to the study participation.  
 
 Related – The AE is known to occur with the study intervention, there is a reasonable possibility 
that the study intervention caused the AE, or there is a temporal relationship between the study 
intervention and event. Reasonable possibility means that there is evidence to suggest a causal 
relationship between the study intervention and the AE. 
 Not Related – There is not a reasonable possibility that the administration of the study 
intervention caused the event, there is no temporal relationship between the study intervention 
and event onset, or an alternate etiology has been established. 
 
8.2.3 Expectedness 
Dr. Abraham Brody will be responsible for determining whether an AE is expected or unexpected. An AE 
will be considered unexpected if the nature, severity, or frequency of the event is not consistent with the 
risk information previously described for the study intervention. 
8.3
Time Period and Frequency for Event Assessment and Follow-Up 
We will follow the reporting requirements outlined in the NYU SOM IRB policies and procedures. Figure 4 
and Figure 5 are screenshots of the reporting requirements. 
 

Study number: s22-01093
Page 27
Version: 6.0     Date: 04/15/2024
CONFIDENTIAL
This material is the property of the NYU Langone Health.  Do not disclose or use except as authorized in writing by the study
sponsor
Behavioral Intervention Template Version: 18 July 2022
Figure 4. Defintions of Adverse Event, Unrelated and Related to the Rearch and Reporting Requirements

Study number: s22-01093
Page 28
Version: 6.0     Date: 04/15/2024
CONFIDENTIAL
This material is the property of the NYU Langone Health.  Do not disclose or use except as authorized in writing by the study
sponsor
Behavioral Intervention Template Version: 18 July 2022
Figure 5. Reporting Requirements (con.)

Study number: s22-01093
Page 29
Version: 6.0     Date: 04/15/2024 
 
 
CONFIDENTIAL 
This material is the property of the NYU Langone Health.  Do not disclose or use except as authorized in writing by the study 
sponsor 
Behavioral Intervention Template Version: 18 July 2022
8.4
Reporting Procedures – Notifying the IRB 
There are no anticipated SAE related to this minimal risk study. Any AE or SAE that is determined by the 
study medical monitor to be related to the study, or an unanticipated problem, will be reported following the 
NYU SoM IRB policies and procedures (also see Figure 4 and Figure 5).
8.4.1 Adverse Event Reporting 
We recognize that some caregivers might experience psychological distress resulting from learning a new 
mHealth app during the feasibility trial. Therefore, we will passively monitor any psychological distress 
reported by caregivers. The term “passive” or “passively” refers to the reliance on voluntary caregiver report, 
in contrast to the study team’s administration of regular screening throughout the study period to “actively” 
monitor any changes in psychological distress in caregiver participants.  
A summary of all adverse events and serious adverse events will be reported to the NIA Program Officer 
and the Safety Officer on a quarterly basis.   
8.4.2 Serious Adverse Event Reporting 
This is a minimal risk study and we do not anticipate any serious adverse events resulting from study 
participation. Any unanticipated SAE that is determined to be related to this study will follow the following 
reporting procedure: 
 
Unanticipated Problem Reporting 
 
Upon notification of any Unanticipated Problems:  
1. PI Lin will first notify the NYU Medical Monitor, Dr. Abraham A. Brody, within 24 hours to 
determine whether the unanticipated problem is related to study participation.  
2. PI Lin will send out a notification email to the IRB, the Emory Roybal Center (to forward the 
information to the NIA Program Officer), and the Safety Officer within 48 hours of any 
unanticipated problem that is determined to be related to study participation. 
3. PI Lin will also submit a Reportable New Information form in the Research Navigator within 5 
calendar days of IRB-reportable AE/SAE/Unanticipated Problems including breaches of 
confidentiality.  
4. Upon advisement by the IRB, NIA, and Safety Officer, PI Lin will determine the study’s 
status and notify the Study Team. 
5. PI Lin will advise the Study Team regarding screening, enrollment, and ongoing 
participation. 
8.4.3 Reporting of Pregnancy 
Not applicable.  
8.5 Reporting Procedures – Notifying the Study Sponsor
Per NIA policy, all AE that are serious and unexpected should be submitted to the NIA and Safety Officer 
within 48 hours of the site awareness. The Safety Officer will propose AE and SAE definitions and 
frequency of monitoring and reporting. A copy of the data safety monitoring plan will be attached to this 
study protocol once it is approved by the NIA-appointed Safety Officer. 
 
There are no specific stopping rules of the study given that this is a minimal risk study. However, the 
study may be terminated or suspended based on the judgement of the Safety Officer. 

Study number: s22-01093
Page 30
Version: 6.0     Date: 04/15/2024 
 
 
CONFIDENTIAL 
This material is the property of the NYU Langone Health.  Do not disclose or use except as authorized in writing by the study 
sponsor 
Behavioral Intervention Template Version: 18 July 2022
8.6
Study Halting Rules
Aim 1 co-design workshop: Not applicable. No intervention will be implemented during the co-design 
workshop. Participants will only review the proposed intervention contents for the Aim 2 feasibility trial 
and provide feedback for improvement/refinement. The purpose is to understand the participants’ 
preferences.  
 
Aim 2 Feasibility Trial: This study phase may be temporarily suspended or prematurely terminated if there 
is sufficient reasonable cause. Safety-related temporary suspension or termination will be determined by 
the Safety Officer.  
 
Written notification, documenting the reason for study suspension or termination, will be provided by the 
suspending or terminating party to all investigators, the funding agency, and regulatory authorities. If the 
study is prematurely terminated or suspended, the PI will promptly inform the IRB and will provide the 
reason(s) for the termination or suspension. 
Circumstances that may warrant termination or suspension include, but are not limited to: 
 
Determination of unexpected, significant, or unacceptable risk to participants 
 
Demonstration of efficacy that would warrant stopping 
 
Insufficient compliance to protocol requirements 
 
Data that are not sufficiently complete and/or evaluable 
 
Determination of futility 
 
Study may resume once concerns about safety, protocol compliance, and data quality are addressed and 
satisfy the sponsor and/or IRB. 
 
8.7
Safety Oversight 
It is the responsibility of the PI to oversee the safety of the study. Any AE/SAE will first be reported to the 
PI and then forwarded to the local Medical Monitor, Dr. Abraham A. Brody, to adjudicate their severity and 
relatedness to study participation. The Medical Monitor will review all AEs on a regular basis throughout 
the trial and be available to advise the PI on trial related medical questions or problems. This safety 
monitoring will include careful assessment and appropriate reporting of AE/SAE following the approved 
study data and safety-monitoring plan approved by the Safety Officer. Medical monitoring will include a 
regular assessment of the number and type of serious adverse events. The NIA-appointed Safety Officer 
will review the data safety monitoring plan and the IRB-approved study protocol. Handeling of protocol 
deviations is detailed in Section 14.3 below.  
 
Data safety monitoring reports will be submitted to the IRB during the annual continuing review, unlesss a 
shorter reporting period is required by the IRB.  
 
Medical Monitor: Dr. Abraham A. Brody 
Dr. Brody is the associate director of the Hartford Institute for Geriatric Nursing and professor in 
the Departments of Nursing and Medicine at NYU Grossman School of Medicine. He is a board 
certified geriatric and palliative nurse practitioner who is priviledged at NYU Langone to perform 
research monitoring as a member of the medical and dental staff. As part of his experience and 
expertise, including in several prior NIH funded extramural awards, Dr. Brody will perform 
assessments of emergent depressive or other psychological symptoms identified in participants 
and determine the need for referral, treatment, or emergent services. 
 
Safety oversight will be under the direction of an NIA-approved Safety Officer, Dr. Kenneth Boockvar. The 
Safety Officer will evaluate cumulative participant safety data and make recommendations regarding the 
safety continuation of the study. The Safety Officer will define and approve all data elements needed to 
assess trial safety.  
 

Study number: s22-01093
Page 31
Version: 6.0     Date: 04/15/2024 
 
 
CONFIDENTIAL 
This material is the property of the NYU Langone Health.  Do not disclose or use except as authorized in writing by the study 
sponsor 
Behavioral Intervention Template Version: 18 July 2022
 
Safety Officer: Dr. Kenneth Boockvar  
Dr. Boockvar is Acting Director at JJ Peters VA Medical Center; Professor of Geriatrics and Palliative 
Medicine, Icahn School of Medicine at Mount Sinai; and Director of Clinical Studies, Jewish Home 
Lifecare. Dr. Boockvar has considerable experience conducting research and implementing geriatrics 
models of care with front-line health care providers, including developing, implementing, and testing 
interventions designed to prevent delirium. Dr. Boockvar has been the PI on projects examining care 
for patients with complex illness since 2000, with continuous funding since 2001, using health 
services and clinical research methods, both qualitative and quantitative. Currently, Dr. Boockvar is 
the PI on projects examining 1) medication prescribing in nursing home residents and individuals with 
dementia; and 2) delirium assessment and prevention in long-term nursing home residents. As a 
leader/core leader of the VA Center for Medication Safety in Aging, the U.S. Deprescribing Research 
Network, and the Mount Sinai Pepper Center, Dr. Boockvar has considerable experience reviewing 
and monitoring clinical trials. 
9
Study Monitoring
Study site monitoring is conducted to ensure that the rights and well-being of human subjects are 
protected, that the reported trial data are accurate, complete, and verifiable, and that the conduct of the 
trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with applicable 
regulatory requirement(s). 
 
 The PIs will conduct centralized monitoring of all data collected for the feasibility trial; assess data 
quality on a weekly basis during the weekly PI meetings with 100% data verification; and generate 
quarterly data monitoring reports.   
 
 The PIs will monitor all visits and study forms to:  
o 
Ensure maintenance of required study documents 
 
o 
Verify adherence to the study protocol 
o 
Monitor the quality of data collected 
o 
Ensure accurate reporting and documentation of all adverse events and unanticipated 
problems 
o 
Ensure the rights and safety of participants 
o 
Confirm that the study is conducted in accordance with GCP guidelines 
 
 During weekly PI meetings, the PIs will review all study forms completed in the previous week to 
ensure: 
o 
Informed consent has been obtained and documented in accordance with IRB regulations 
o 
The information recorded on the forms is complete and accurate 
o 
There are no omissions in the reports of specific data elements 
o 
Missing visits are indicated on the forms 
o 
Participant disposition when exiting the study is accurately recorded 
o 
All errors and corrective actions will be entered into a Data Management Log and the 
Protocol Deviation Form as appropriate.  
10 Statistical Considerations 
10.1 Statistical and Analytical Plans
Statistical considerations of this study are described in the following sections. However, given that this is 
a small feasibility trial, no additional formal Statistical Analytical Plan will be developed.  
10.2 Statistical Hypotheses 
Primary hypothesis:  The Aliviado DSD Caregiving Mastery Program will be feasible, acceptable and 
usable to family caregivers of persons living with dementia at risk for DSD.  

Study number: s22-01093
Page 32
Version: 6.0     Date: 04/15/2024 
 
 
CONFIDENTIAL 
This material is the property of the NYU Langone Health.  Do not disclose or use except as authorized in writing by the study 
sponsor 
Behavioral Intervention Template Version: 18 July 2022
 
Secondary hypothesis: The Aliviado DSD Caregiving Mastery Program will improve caregivers’ delirium 
knowledge and DSD caregiving mastery, as well as decrease caregiver strain, depression, and burden. 
10.3 Analysis Datasets
Aim 1 and Aim 2 samples will be analyzed separately.    
10.4 Description of Statistical Methods 
10.4.1 General Approach 
Descriptive statistics will be calculated to summarize caregiver characteristics and baseline data. 
Continuous variables will be presented as mean and standard deviations (or median and interquartile 
ranges). Categorical variables will be presented as percentages.  
10.4.2 Analysis of the Primary Efficacy Endpoint(s)
The primary endpoint of this study is feasibility, acceptability, and app usability. Descriptive statistics will 
be calculated to summarize feasibility, acceptability, and app usability outcomes. Estimates will be 
reported with 95% confidence intervals. 
10.4.3 Analysis of the Secondary Endpoint(s) 
Paired t-tests will be performed to compare changes in delirium knowledge and caregiving mastery from 
baseline to 2 weeks (immediately post training), and changes in delirium knowledge, caregiving mastery, 
caregiver strain, depression, and burden from baseline to posttest (Week 6); effect sizes (Cohen’s d) will 
be reported for all outcomes. To maintain the familywise error rate, we will use Bonferroni-adjusted alpha 
to determine significance. 
 
10.4.4 Safety Analyses 
NA 
10.4.5 Adherence and Retention Analyses 
We will calculate the Aim 1 co-design workshop attendance rate.  
Adherence to the Aim 2 intervention will be assessed by the number of delirium assessments performed, 
the number of videos watched, and the daily DSD prevention management tasks logged. We will also 
calculate the retention rate (i.e., the number of participants who complete the study divided by the number 
of participants enrolled).  
 
We will conduct an exploratory analysis to assess the dose effect, using a linear mixed model to 
examine caregiver knowledge gains, controlling for the degree of video completion. While not sufficiently 
powered, this analysis will provide preliminary estimates of the impact associated with degree of 
participation on caregiver knowledge, and will provide informative context for the results from the 
unadjusted analyses. Estimates will be reported with 95% confidence intervals to convey the precision of 
estimates. 
10.4.6 Baseline Descriptive Statistics 
Descriptive statistics will be calculated for all variables collected at the baseline/enrollment visit.  
10.4.7 Planned Interim Analysis 
Not applicable (NA).  

Study number: s22-01093
Page 33
Version: 6.0     Date: 04/15/2024 
 
 
CONFIDENTIAL 
This material is the property of the NYU Langone Health.  Do not disclose or use except as authorized in writing by the study 
sponsor 
Behavioral Intervention Template Version: 18 July 2022
10.4.7.1 Efficacy Review 
NA 
10.4.8 Additional Sub-Group Analyses 
NA 
10.4.9 Multiple Comparison/Multiplicity 
NA 
10.4.10 
Tabulation of Individual Response Data 
NA
10.4.11
Exploratory Analyses
We will also track the usage of the intervention by secondary caregivers enrolled, if any. If 
enough secondary caregivers participate, we will also explore changes in their delirium knowledge and 
caregiving mastery outcomes. 
10.5 Sample Size
Aim 1 co-design workshop: We aim for 5-8 participants per session based on recommendations from 
Smaradottir et al.29 and our consultation with a Design Thinking expert from the Emory Roybal Center 
Design Studio. Accordingly, the target sample size is 8 caregivers (plus 8 on the waitlist). 
 
Aim 2 feasibility trial: Because improvement in delirium knowledge should occur before improvement of 
caregiver mastery, our power calculation is based on delirium knowledge. Home health aides exposed to 
the current Aliviado videos demonstrated medium-to-large knowledge gains (Cohen’s d = .64). We will have 
80% power to detect an effect of this magnitude in 26 caregivers, using a Bonferroni adjusted significance 
 = .025. The expected gains will likely be larger, as previous research with a similar delirium 
intervention using telephone-based education modules found even greater improvement at 2 weeks 
(Cohen’s d = .86) and 2 months (d = .87) post-intervention,30 and our projected sample of 26 will yield >99% 
power to detect similar effects. To allow for a 12% dropout rate and remain adequately powered, we aim to 
recruit 30 caregivers. 
10.6 Measures to Minimize Bias
10.6.1 Enrollment/Randomization/Masking Procedures 
NA 
10.6.2 Evaluation of Success of Blinding 
Not applicable.  
10.6.3 Breaking the Study Blind/Participant Code 
Not applicable.  
11 Source Documents and Access to Source Data/Documents 
All data collected for this study will be maintained in an electronic format. All e-Consent and HIPAA 
documents will be collected and stored on the password-protected REDCap system with 2 factor-
authentication. All surveys will be collected through online NYU REDCap survey quesionanires, cleaned, 
deidentified, and uploaded to a secure folder in PI Lin’s password-protected NYU Box research space with 

Study number: s22-01093
Page 34
Version: 6.0     Date: 04/15/2024 
 
 
CONFIDENTIAL 
This material is the property of the NYU Langone Health.  Do not disclose or use except as authorized in writing by the study 
sponsor 
Behavioral Intervention Template Version: 18 July 2022
2 factor-authentication. Where there are unanticipated problems, adverse events or serious adverse 
events, the corresponding report forms will be filled out and maintained in REDCap. Protocol deviation 
forms will be filled out and maintained in a secure folder within PI Lin’s NYU Box research space for 
reporting purposes. PI Lin will be responsible for creating and maintaining an electronic study binder in 
REDCap. During weekly meetings, PI Lin and PI Choi will review all forms completed in the previous week 
to ensure accuracy, as well as edit/update the forms as needed. All corrections made will be recorded in a 
Data Management Log in a secure folder within PI Lin’s NYU Box research space and be updated and 
maintained by both PIs.  
12 Quality Assurance and Quality Control 
Validation checks will be set up for all items in all electronic study forms and surveys. Survey data will be 
downloaded in csv or Excel format, deidentified, and cleaned in STATA and/or R on a weekly basis, 
uploaded to a secure folder within PI Lin’s NYU Box research space and then be reviewed during the weekly 
PI meeting to ensure accuracy. Descriptive statistics and graphs will be used to identify outliers and unusual 
values.  
 
During the weekly PI meetings, the PIs will review the REDCap dashboard and verify that all forms are 
complete and on schedule; reasons for incomplete or delays in completion will be recorded in REDCap 
(and the Protocol Deviation Form if applicable). Any potential data entry errors will be discussed and 
corrected during the weekly PI meeting. All corrections made will be recorded in the Data Management 
Log. If needed, the PIs will reach out to participants to confirm their information accuracy.  
Recordings from the co-design workshop (audio, video, live chat) will be encrypted and labeled only with 
a code number, which will be kept in a password-protected REDCap folder only accessible by the 
Principal Investigator and the co-Principal Investigator.  Recordings will then be transcribed, deidentified 
and uploaded to a secure folder in PI Lin’s NYU Box research space with two factor authentication for 
later data analysis. PIs will verify accuracy of the transcripts and the original recordings may be consulted 
as needed. 
 
13 Ethics/Protection of Human Subjects 
13.1 Ethical Standard
The investigator will ensure that this study is conducted in full conformity with Regulations for the 
Protection of Human Subjects of Research codified in 45 CFR Part 46. 
13.2 Institutional Review Board
The protocol, informed consent form(s), recruitment materials, and all participant materials will be 
submitted to the IRB for review and approval. Approval of both the protocol and the consent form must be 
obtained before any participant is enrolled. Any amendment to the protocol will require review and 
approval by the IRB before the changes are implemented to the study. All changes to the consent form 
will be IRB approved; a determination will be made regarding whether previously consented participants 
need to be re-consented. 
 
 
13.3 Informed Consent Process
13.3.1 Consent/Assent and Other Informational Documents Provided to Participants 

Study number: s22-01093
Page 35
Version: 6.0     Date: 04/15/2024 
 
 
CONFIDENTIAL 
This material is the property of the NYU Langone Health.  Do not disclose or use except as authorized in writing by the study 
sponsor 
Behavioral Intervention Template Version: 18 July 2022
Consent forms describing in detail the study intervention, study procedures, and risks are given to the 
participant and written documentation of informed consent is required prior to participating in any study 
activities. 
13.3.2 Consent Procedures and Documentation
All informed consent will be completed following the HIPAA compliant, remote e-Consenting method 
approved by NYU Langone Health. A potential caregiver participant will first be screened remotely through 
a telephone call with PIs (or be pre-screened by a research assistant during a recruitment call and then 
formally screened by the PIs via phone) to confirm eligibility. If the caregiver is eligible and wishes to 
participate, PIs will then schedule a follow-up Zoom call (via HIPAA compliant Zoom) with the caregiver to 
complete the e-Consenting process together in REDCap. A copy of the consent form will be emailed or 
mailed to the potential caregiver subject in advance to review before the consenting Zoom call. During the 
HIPAA compliant Zoom call, PIs will share the screen and go over the IRB-approved REDCap e-consent 
and HIPAA authorization form, page by page, with the caregiver. The e-consent process informs the 
potential caregiver participant about the study, describes potential risks and benefits, indicates that the 
participation is voluntary and that he/she has the right to stop at any time. PIs will also provide the potential 
caregiver participant contact information in case of medical emergency due to study participation and 
questions about subject rights, as well as explain who have access to study data and protected health 
information, how confidentiality is maintained, how the participant may receive the outcome of the study 
and incentives for study participation. 
 
PIs will ensure that the eligible caregiver has the opportunity to consider whether to participate and ask 
questions before electronically signing the consent and HIPAA authorization form in REDCap during the 
Zoom call, as well as at anytime during their involvement in the research study. If the caregiver decides to 
give consent, PIs will give the caregiver remote control over the mouse of the PI’s device to initial and sign 
the REDCap e-consent and HIPAA authorization form in REDCap. After signing electronically, the caregiver 
will receive an electronic copy of the signed consent and HIPAA authorization form immediately in an 
automatically generated email from REDCap. If caregivers have difficulty signing through remoate control 
over the PI’s mouse, then a link to the REDCap e-consent form will be emailed to the caregiver to sign and 
initial in REDCap, Caregivers enrolled in the feasibility study phase will have the option to include additional 
secondary caregivers, who will undergo the same e-Consenting process. Electronic informed consent and 
HIPAA authorization documents with subject information will be collected, stored, and maintained on the 
password-protected REDCap system with 2 factor-authentication. Only authorized study team members 
will have access to the consent and HIPAA authorization forms stored in REDCap.   
13.3.3 Waiver of Authorization/Consent 
The following is applicable to Aim 2 feasibility trial only:  
The study team will obtain a waiver of authorization/consent to view the patient’s discharge status in EPIC 
to determine whether and when to contact the potential caregiver participants referred by the inpatient 
geriatrics consult teams (see 5.4.4 Clinician Referral). According to feedback from the inpatient geriatric 
consult team, caregivers are too overwhelmed to consider study participation when their loved one is still 
in the hospital. The referral clinician suggests that the study team reaches out to caregivers only after 
their loved one is discharged. Because the referral clinician cannot predict the discharge date and 
location in advance and suggests that after they have made the referral, the study team monitors the 
patient’s discharge status in EPIC to determine whether and when to follow up with their caregiver about 
study participation.  
 
13.4 Posting of Clinical Trial Consent Form 
Not applicable.   
 

Study number: s22-01093
Page 36
Version: 6.0     Date: 04/15/2024 
 
 
CONFIDENTIAL 
This material is the property of the NYU Langone Health.  Do not disclose or use except as authorized in writing by the study 
sponsor 
Behavioral Intervention Template Version: 18 July 2022
13.5 Participant and Data Confidentiality
Information about study subjects will be kept confidential and managed according to the requirements of 
the Health Insurance Portability and Accountability Act of 1996 (HIPAA).  Those regulations require a 
signed subject authorization informing the subject of the following:  
 What protected health information (PHI) will be collected from subjects in this study 
 Who will have access to that information and why 
 Who will use or disclose that information  
 The rights of a research subject to revoke their authorization for use of their PHI.  
 
In the event that a subject revokes authorization to collect or use PHI, the investigator, by regulation, 
retains the ability to use all information collected prior to the revocation of subject authorization.  For 
subjects that have revoked authorization to collect or use PHI, attempts should be made to obtain 
permission to collect at least vital status (i.e. that the subject is alive) at the end of their scheduled study 
period. 
 
Participant confidentiality is strictly held in trust by the participating investigators, their staff, and the 
sponsor(s) and their agents. This confidentiality is extended to cover testing of biological samples and 
genetic tests in addition to the clinical information relating to participants. Therefore, the study protocol, 
documentation, data, and all other information generated will be held in strict confidence. No information 
concerning the study or the data will be released to any unauthorized third party without prior written 
approval of the sponsor. 
 
The study monitor, other authorized representatives of the sponsor, or representatives of the IRB may 
inspect all documents and records required to be maintained by the investigator, including but not limited 
to, medical records (office, clinic, or hospital) and pharmacy records for the participants in this study. The 
clinical study site will permit access to such records. 
 
The study participant’s contact information will be securely stored in REDCap for internal use during the 
study. At the end of the study, all records will continue to be kept in a secure location for as long a period 
as dictated by local IRB and Institutional regulations. 
 
Study participant research data, which is for purposes of statistical analysis and scientific reporting, will 
be deidentified and stored in a password-protected NYU Box folder. This will not include the participant’s 
contact or identifying information. Rather, individual participants and their research data will be identified 
by a unique study identification number. The study data entry and study management systems used by 
the study team will be secured and password protected.   
 
13.5.1 Research Use of Stored Human Samples, Specimens, or Data 
Data collected from this study will be deidentified and shared following NIH’s data sharing policy as 
appropriate.  
13.6 Future Use of Stored Specimens
NA. 
14 Data Handling and Record Keeping 
14.1 Data Collection and Management Responsibilities
A research assistant trained by the PI will conduct phone recruitment and log phone 
screening/recruitment results in REDCap (e.g., interested/declined/did not answer). The PIs will collect 
the rest of the study data and will be responsible for managing and validating of all study data.   

Study number: s22-01093
Page 37
Version: 6.0     Date: 04/15/2024 
 
 
CONFIDENTIAL 
This material is the property of the NYU Langone Health.  Do not disclose or use except as authorized in writing by the study 
sponsor 
Behavioral Intervention Template Version: 18 July 2022
14.1.1 Data Collection in REDCap Online Survye Questinonaires
PIs will complete measures specified in Table 3 and Table 4 in REDCap online survey qeustionnaires based 
on caregiver report.  
Table 3. Aim 1 Measures (In the Form of Online REDCap Survey Quesionnaires) 
Variable
Measure
Administration Time (mins)a
Caregiver and care recipient 
demographics information
Demographic quesionnaires 
developed by the study team.  
5
DSD exposure 
Did your provide care to or visit 
your loved one when he/she had 
a delirium episode within the past 
12 months? (Yes/No) 
<1 
Health literacy
BRIEF Health Literacy Screening
(4 items) 
2 
Comfort with technology 
Functional 
Assessment 
of 
Currently Employed Technology 
Scale (10 items)
3 
Table 4. Aim 2 Measures (in the Form of Online REDCap Qustionniares) 
Variable 
Measure 
Administratio
n Time (mins) 
Timelinea
Baseline/
enrollment 
(Week 0) 
Immediately
post training 
(Week 2) 
Posttest 
(Week 6) 
Caregiver and 
care recipient 
demographics 
information
Demographic questiobnaires 
developed by the study team  
5  
Yes 
-
-
Health literacy
BRIEF Health Literacy Screening 
(4 items)
2
Yes 
-
-
Comfort 
with 
technology 
Functional 
Assessment 
of 
Currently Employed Technology 
Scale (10 items)
3
Yes 
-
-
Dementia 
Severity
Quick Dementia Rating System 
(10 items)
4
Yes 
-
-
Behavioral 
and 
psychological 
symptoms 
of 
dementia
Neuropsychiatric 
Inventory 
Questionnaire (12 items) 
5 
Yes
-
-
Caregiver 
strain
Modified Caregiver Strain Index 
(13 items)
5
Yes 
-
Yes
Caregiver 
Depression 
Center 
for 
Epidemiological 
Studies Depression Scale (20 
items)
4
Yes 
-
Yes
Caregiver 
Burden 
Short 
Form 
Zarit 
Burden 
Interview (12 items) 
3
Yes 
-
Yes
General 
caregiving 
self-efficacy
Revised Scale for Caregiving 
Self-Efficacy (15 items) 
3
Yes 
-
Yes
DSD 
Caregiving 
Mastery
A 
DSD 
Competence 
Scale 
modified 
from 
Pearline’s 
Competence 
Scale 
with 
5
Yes 
Yes 
Yes

Study number: s22-01093
Page 38
Version: 6.0     Date: 04/15/2024 
 
 
CONFIDENTIAL 
This material is the property of the NYU Langone Health.  Do not disclose or use except as authorized in writing by the study 
sponsor 
Behavioral Intervention Template Version: 18 July 2022
additional items developed by the 
Aliviado 
team 
to 
assess 
confidence and completion of 
DSD prevention, detection, and 
management tasks (14 items)
Caregiver 
Delirium 
Knowledge
Caregiver Delirium Knowledge 
Questionnaire (19 items)
5
Yes 
Yes 
Yes
Program 
satisfaction 
13 
Likert-type 
questions 
to 
assessment program satisfaction 
and willingness to recommend 
the program plus one optional 
open-ended question to provide 
additional feedback (14 items 
total) 
 
3-5
-
-
Yes
Usability
A 
modified 
IBM 
Computer 
Usability 
Satisfaction 
Questionnaire developed by the 
Aliviado team (24 Likert-type 
questions + 3 optional open-
ended 
questions 
to 
provide 
additional feedback) 
5-10
 - 
-
Yes
14.1.2 Data Collection Tools – Mobile Health Technology 
Products and Devices 
The Aliviado mHealth app is NYU-housed and will only be used to collect study data with IRB approval and 
if the subject has agreed to all applicable Terms of Service. The Aliviaod mHealth app does not include 
location tracking services. The app will not track participants’ geographic location or physical activities. 
Time logged in to the app, number of care plans and assessments completed, number of videos watched, 
etc. will be automatically tracked by the Aliviado app (app usage). 
14.2 Study Records Retention 
All study records will be maintained for at least three years after the conclusion of final 
reporting/publication. These documents should be retained for a longer period, however, if required by 
local regulations. No records will be destroyed without the written consent of the sponsor, if applicable. It 
is the responsibility of the sponsor to inform the investigator when these documents no longer need to be 
retained. All identifiers will be destroyed 3 years after the end of the study. Deidentified data may be 
uploaded to the NYU data repository or an external data repository if required by the NIH/NIA.    
14.3 Protocol Deviations
A protocol deviation is any noncompliance with the clinical trial protocol, GCP, or MOP requirements. The 
noncompliance may be either on the part of the participant, the investigator, or the study site staff. As a 
result of deviations, corrective actions are to be developed by the site and implemented promptly. 
It is the responsibility of the PI to not deviate from the protocol approved by the IRB, except to avoid an 
immediate hazard to the subject. The PI will submit an amendment request to the IRB and receive written 
approval prior to the implementation of any change to the protocol. 
It is the responsibility of the study site to use continuous vigilance to identify and report deviations within 2 
working days (48 hours) of identification of the protocol deviation, or within 2 working days (48 hours) of 
the scheduled protocol-required activity. All deviations must be addressed in study source documents. 

Study number: s22-01093
Page 39
Version: 6.0     Date: 04/15/2024 
 
 
CONFIDENTIAL 
This material is the property of the NYU Langone Health.  Do not disclose or use except as authorized in writing by the study 
sponsor 
Behavioral Intervention Template Version: 18 July 2022
The PI will report protocol deviations that impact participant safety within 48 hours of occurrence to the 
study Medical Monitor (Dr. Ab Brody), IRB, NIA Program Officer (via Emory Roybal Center for Caregiving 
Mastery), and the Safety Officer. All other deviations will be reported as part of the quarterly Data Safety 
and Monitoring Report to the NIA/Emory Roybal Center for Caregiving Mastery and the Safety Officer. 
The PI will maintain a log of all protocol deviations and causes, develop mitigation measures within 7 
days of any protocol deviations/violations, and notify the whole study team of such measures to ensure 
no further issues.  
 
Protocol deviations/violations, include, but are not limited to, the following: 
 
Enrollment of an ineligible participant 
 
Failure to obtain Informed Consent 
 
Visits or procedures conducted outside of the protocol specified window  
 
Failure to keep IRB approval up to date 
 
Follow-up visit at a time point different from that specified in the protocol 
 
 
These practices are consistent with ICH E6: 
 4.5 Compliance with Protocol, sections 4.5.1, 4.5.2, and 4.5.3 
 5.1 Quality Assurance and Quality Control, section 5.1.1 
 5.20 Noncompliance, sections 5.20.1, and 5.20.2. 
14.4 Publication and Data Sharing Policy 
The International Committee of Medical Journal Editors (ICMJE) member journals have adopted a clinical 
trials registration policy as a condition for publication. The ICMJE defines a clinical trial as any research 
project that prospectively assigns human subjects to intervention or concurrent comparison or control 
groups to study the cause-and-effect relationship between a medical intervention and a health outcome. 
Medical interventions include drugs, surgical procedures, devices, behavioral treatments, process-of-care 
changes, and the like. Health outcomes include any biomedical or health-related measures obtained in 
patients or participants, including pharmacokinetic measures and adverse events. The ICMJE policy, and 
the Section 801 of the Food and Drug Administration Amendments Act of 2007, requires that all clinical 
trials be registered in a public trials registry such as ClinicalTrials.gov, which is sponsored by the National 
Library of Medicine. Other biomedical journals are considering adopting similar policies. For interventional 
clinical trials performed under NIH IC grants and cooperative agreements, it is the grantee’s responsibility 
to register the trial in an acceptable registry, so the research results may be considered for publication in 
ICMJE member journals. The ICMJE does not review specific studies to determine whether registration is 
necessary; instead, the committee recommends that researchers who have questions about the need to 
register err on the side of registration or consult the editorial office of the journal in which they wish to 
publish.  
 
This pilot study will be registered on the ClinicalTrials.gov and the publication and authorship policies will 
follow the Aliviado Health Team Authorship Guidelines (See Attahcment B). The Aliviado Health Team 
Authorship Guidelines are consistent with the ICMJE authorship recommendations.  
 
This study will comply with the NIH Public Access Policy, which ensures that the public has access to the 
published results of NIH funded research. It requires scientists to submit final peer-reviewed journal 
manuscripts that arise from NIH funds to the digital archive PubMed Central upon acceptance for 
publication. 
15 Study Finances 
15.1 Funding Source 
This study is financed through a subaward (A684268) of the NIA-funded, Emory Roybal Center for 
Dementia Caregiving Mastery pilot program (5P30AG064200-04). 

Study number: s22-01093
Page 40
Version: 6.0     Date: 04/15/2024 
 
 
CONFIDENTIAL 
This material is the property of the NYU Langone Health.  Do not disclose or use except as authorized in writing by the study 
sponsor 
Behavioral Intervention Template Version: 18 July 2022
15.2 Costs to the Participant
There are no costs to the participants. 
15.3 Participant Reimbursements or Payments 
Aim 1 co-design workshop: Caregiver subjects will receive a $90 gift card at the end of each co-design 
session completed (total of $450 if all sessions are completed).  
 
Aim 2 feasibility trial: Primary caregiver participants will receive a $25 gift card for completing the first data 
collection session (enrollment/baseline), another $25 gift card for completing the second data collection 
session (Week 2/immediately post training) and a $50 gift card for completing the posttest data collection 
session (Week 6). Secondary caregivers referred to the study by an enrolled primary caregiver will not 
receive any payments after each data collection session but will be entered into a raffle of one $100 gift 
card at the end of the study.  
16 Study Administration
16.1 Study Leadership
The study will be co-led by the PI Lin and PI Choi. PI Lin and PI Choi will provide oversight of the entire 
project including subject recruitment; data collection, analysis, and management; and dissemination of 
the study findings. PI Choi will be responsible for leading the Aim 1 co-design workshop. PI Lin will be 
responsible for leading the Aim 2 feasibility trial. PI Lin will serve as contact PI and assume fiscal and 
administrative management including communication between PIs and other research team members, 
hosting quarterly research team meetings (additional meetings will be scheduled as needed), 
communication with the Roybal Center, NIA, Safety Officer, and NYU School of Medicine IRB, and timely 
submission of the biannual progress reports and other required documents.  
17 Conflict of Interest Policy 
The study will manage actual or perceived conflicts of interest following NYU Langone Health’s Policy on 
Conflicts of Interest in Research and Other Sponsored Programs. Under this Policy, individuals participating 
in research and other sponsored programs must disclose all financial interests that reasonably appear to 
be related to the individual’s responsibilities at NYU Langone Health and to the specific project. NYU 
Langone Health, through its Conflicts of Interest Management Unit (CIMU), will then review and evaluate 
such disclosures, determine if a conflict of interest exists, and determine whether such conflict can be 
managed or must be eliminated in order to permit the researcher to engage in the project.  
  
18 References 
1. Fick DM, Agostini JV, Inouye SK. Delirium superimposed on dementia: a systematic review. Journal of 
the American Geriatrics Society. 2002;50(10):1723-1732. doi:10.1046/j.1532-5415.2002.50468.x 
2. Fick D, Foreman M. Consequences of not recognizing delirium superimposed on dementia in 
hospitalized elderly individuals. J Gerontol Nurs. 2000;26(1):30-40. doi:10.3928/0098-9134-20000101-
09 
3. Fick DM, Steis MR, Waller JL, Inouye SK. Delirium superimposed on dementia is associated with 
prolonged length of stay and poor outcomes in hospitalized older adults. J Hosp Med. 2013;8(9):500-
505. doi:10.1002/jhm.2077 
4. Morandi A, Davis D, Fick DM, et al. Delirium superimposed on dementia strongly predicts worse 
outcomes in older rehabilitation inpatients. Journal of the American Medical Directors Association. 
2014;15(5):349-354. doi:10.1016/j.jamda.2013.12.084 

Study number: s22-01093
Page 41
Version: 6.0     Date: 04/15/2024 
 
 
CONFIDENTIAL 
This material is the property of the NYU Langone Health.  Do not disclose or use except as authorized in writing by the study 
sponsor 
Behavioral Intervention Template Version: 18 July 2022
5. Bruera E, Bush S, Willey J, et al. The impact of delirium and recall on the level of distress in patients 
with 
advanced 
cancer 
and 
their 
family 
caregivers. 
Cancer. 
2009;115(9):2004-2012. 
doi:10.1002/cncr.24215 
6. Fong TG, Racine AM, Fick DM, et al. The caregiver burden of delirium in older adults with Alzheimer 
disease and related disorders. Journal of the American Geriatrics Society. 2019;67(12):2587-2592. 
doi:10.1111/jgs.16199 
7. Steis MR, Evans L, Hirschman KB, et al. Screening for delirium via family caregivers: Convergent 
validity of the Family Confusion Assessment Method (FAM-CAM) and interviewer-rated CAM. J Am 
Geriatr Soc. 2012;60(11):2121-2126. doi:10.1111/j.1532-5415.2012.04200.x 
8. Krewulak KD, Sept BG, Stelfox HT, et al. Feasibility and acceptability of family administration of delirium 
detection tools in the intensive care unit: a patient-oriented pilot study. CMAJ Open. 2019;7(2):E294-
E299. doi:10.9778/cmajo.20180123 
9. Fiest KM, Krewulak KD, Ely EW, et al. Partnering with family members to detect delirium in critically ill 
patients. Crit Care Med. 2020;48(7):954-961. doi:10.1097/CCM.0000000000004367 
10. Parsons Leigh J, Krewulak KD, Zepeda N, et al. Patients, family members and providers perceive 
family-administered delirium detection tools in the adult ICU as feasible and of value to patient care 
and family member coping: a qualitative focus group study. Can J Anaesth. 2021;68(3):358-366. 
doi:10.1007/s12630-020-01866-3 
11. Flanagan NM, Spencer G. Informal caregivers and detection of delirium in postacute care: a 
correlational study of the confusion assessment method (CAM), confusion assessment method-family 
assessment method (CAM-FAM) and DSM-IV criteria. Int J Older People Nurs. 2016;11(3):176-183. 
doi:10.1111/opn.12106 
12. Mailhot T, Darling C, Ela J, Malyuta Y, Inouye SK, Saczynski J. Family Identification of delirium in the 
emergency department in patients with and without dementia: Validity of the Family Confusion 
Assessment Method (FAM-CAM). J Am Geriatr Soc. 2020;68(5):983-990. doi:10.1111/jgs.16438 
13. Mailhot T, Cossette S, Bourbonnais A, et al. Evaluation of a nurse mentoring intervention to family 
caregivers in the management of delirium after cardiac surgery (MENTOR_D): a study protocol for a 
randomized controlled pilot trial. Trials. 2014;15. doi:10.1186/1745-6215-15-306 
14. Wang YY, Yue JR, Xie DM, et al. Effect of the tailored, family-involved Hospital Elder Life Program on 
postoperative delirium and function in older adults: A randomized clinical trial. JAMA Intern Med. 
2020;180(1):17. doi:10.1001/jamainternmed.2019.4446 
15. Brody AA, Guan C, Cortes T, Galvin JE. Development and testing of the Dementia Symptom 
Management at Home (DSM-H) program: An interprofessional home health care intervention to 
improve the quality of life for persons with dementia and their caregivers. Geriatric Nursing. 
2016;37(3):200-206. doi:10.1016/j.gerinurse.2016.01.002 
16. Lin SY, Schneider CE, Bristol AA, et al. Findings of sequential pilot trials of Aliviado Dementia Care to 
inform 
an 
embedded 
pragmatic 
clinical 
trial. 
The 
Gerontologist. 
2020;(gnaa220). 
doi:10.1093/geront/gnaa220 
17. David D, Lin SY, Groom LL, Ford A, Brody AA. Aliviado Mobile App for hospice providers: A usability 
study. J Pain Symptom Manage. Published online August 10, 2021:S0885-3924(21)00473-5. 
doi:10.1016/j.jpainsymman.2021.07.019 

Study number: s22-01093
Page 42
Version: 6.0     Date: 04/15/2024 
 
 
CONFIDENTIAL 
This material is the property of the NYU Langone Health.  Do not disclose or use except as authorized in writing by the study 
sponsor 
Behavioral Intervention Template Version: 18 July 2022
18. Pearlin LI, Mullan JT, Semple SJ, Skaff MM. Caregiving and the stress process: an overview of 
concepts and their measures. Gerontologist. 1990;30(5):583-594. doi:10.1093/geront/30.5.583 
19. Bandura A. Health promotion by social cognitive means. Health Educ Behav. 2004;31(2):143-164. 
doi:10.1177/1090198104263660 
20. Bandura A. Social cognitive theory: an agentic perspective. Annu Rev Psychol. 2001;52:1-26. 
doi:10.1146/annurev.psych.52.1.1 
21. Bandura A. Social Foundations of Thought and Action: A Social Cognitive Theory. 1st edition. Prentice 
Hall; 1985. 
22. Bandura A. Self-efficacy: toward a unifying theory of behavioral change. Psychol Rev. 1977;84(2):191-
215. doi:10.1037//0033-295x.84.2.191 
23. Thaler RH, Sunstein CR. Nudge: Improving Decisions About Health, Wealth, and Happiness. 
Revised&Expanded edition. Penguin Books; 2009. 
24. National Institute on Aging. NIH Stage Model for Behavioral Intervention Development. National 
Institute on Aging. Accessed March 2, 2020. https://www.nia.nih.gov/research/dbsr/nih-stage-model-
behavioral-intervention-development 
25. Bull MJ, Boaz L, Jermé M. Educating family caregivers for older adults about delirium: a systematic 
review. 
Worldviews 
on 
Evidence-Based 
Nursing. 
2016;13(3):232-240. 
doi:https://doi.org/10.1111/wvn.12154 
26. McKenzie J, Joy A. Family intervention improves outcomes for patients with delirium: systematic review 
and meta-analysis. Australas J Ageing. 2020;39(1):21-30. doi:10.1111/ajag.12688 
27. Chelberg GR, Neuhaus M, Mothershaw A, Mahoney R, Caffery LJ. Mobile apps for dementia 
awareness, support, and prevention - review and evaluation. Disabil Rehabil. Published online May 25, 
2021:1-12. doi:10.1080/09638288.2021.1914755 
28. Désormeaux-Moreau M, Michel CM, Vallières M, et al. Mobile apps to support family caregivers of 
people with Alzheimer Disease and Related Dementias in managing disruptive behaviors: Qualitative 
study With users embedded in a scoping review. JMIR Aging. 2021;4(2):e21808. doi:10.2196/21808 
29. Smaradottir BF, Bellika JG, Fredeng A, Fagerlund AJ. User-Centred Design with a remote approach: 
Experiences from the Chronic Pain Project. Stud Health Technol Inform. 2020;275:197-201. 
doi:10.3233/SHTI200722 
30. Bull MJ, Boaz L, Maadooliat M, et al. Preparing family caregivers to recognize delirium symptoms in 
older adults after elective hip or knee arthroplasty. J Am Geriatr Soc. 2017;65(1):e13-e17. 
doi:10.1111/jgs.14535 
 
 
 
 
 
 
 

Study number: s22-01093
Page 43
Version: 6.0     Date: 04/15/2024 
 
 
CONFIDENTIAL 
This material is the property of the NYU Langone Health.  Do not disclose or use except as authorized in writing by the study 
sponsor 
Behavioral Intervention Template Version: 18 July 2022
19 Attachments
 Attachment A: Materials to be Refined/Re-designed with Caregivers (Aim 1 Co-Design Workshop) 
 Attachment B: Publication Policy  
 Attachment C: Schedule of Events 
 Attachment D: Sample push notification/SMS text messages 

Study number: s22-01093
Page 44
Version: 6.0     Date: 04/15/2024 
 
 
CONFIDENTIAL 
This material is the property of the NYU Langone Health.  Do not disclose or use except as authorized in writing by the study 
sponsor 
Behavioral Intervention Template Version: 18 July 2022
Attachment A: Materials to be Refined/Re-designed with Caregivers (Aim 1 Co-Design 
Workshop)
1. Existing Aliviado Home Health/Hospice Aide Educational Video on Delirium: 
Caregiver subjects will watch the aide version and discuss what they like/dislike about 
the video and how to modify the video contents for use by family caregivers. Caregiver 
subjects will also review and provide feedback on the proposed content areas/topics 
for the family caregivers provided below (e.g., Are there any additional topic areas that 
we should also include in the family caregiver training videos?). 
Link to the video: 
https://drive.google.com/file/d/1mSdguwBNL6phJ0fQI-
qfkOuE8hI5rDBm/view?usp=share_link
Proposed contents of DSD training videos for family caregivers (~ 60 min) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Existing topics in the aide training video (7 min total, as shown in the link above)
- What is delirium?
- Symptoms of delirium 
- Delirium vs dementia 
- Delirium vs sundowning 
- Common causes of delirium 
New topics added (informed by literature review) 
- Important role families play in DSD care (5 min) 
- Assess delirium using Family Confusion 
Assessment Method (FAM-CAM) (10 min) 
- 3 case vignettes to practice delirium assessment 
using FAM-CAM (7 min each; 21 min total) 
- Daily prevention/management (10 min) 
- Prevention/management task 
while your loved one is hospitalized (5 min) 
- Discuss probable DSD/de-prescribing using the 
tailored communication guides (5 min) 
 

Study number: s22-01093
Page 45
Version: 6.0     Date: 04/15/2024
CONFIDENTIAL
This material is the property of the NYU Langone Health.  Do not disclose or use except as authorized in writing by the study
sponsor
Behavioral Intervention Template Version: 18 July 2022
2. Delirium Assessment Tools
a. Confusion Assessment Method (CAM) - Short Form: Caregiver subjects will 
provide feedback on the layout/visual presentation of the clinician version of 
the delirium assessment currently in use in the Aliviado app.

Study number: s22-01093
Page 46
Version: 6.0     Date: 04/15/2024
CONFIDENTIAL
This material is the property of the NYU Langone Health.  Do not disclose or use except as authorized in writing by the study
sponsor
Behavioral Intervention Template Version: 18 July 2022
b. Family Confusion Assessment Method (FAM-CAM): Caregiver subjects will 
review the pdf version of the family-administered version of the delirium 
assessment. Caregiver subjects will provide feedback on the clarity of each 
assessment item in the instrument. If there is a confusing item, we will explain 
how to correctly interpret the specific item in the caregiver training video to be 
developed for the Aim 2 feasibility trial. Caregiver subjects will also provide 
feedback on how they want this instrument to be displayed in the app. 
https://americandeliriumsociety.org/wp-content/uploads/2021/08/FAM-
CAM_English.pdf
c. The Sour Seven: This is a newer validated caregiver-administered delirium 
assessment. The Sour Seven has fewer items than the FAM-CAM. We will 
show this assessment instrument to the caregiver subjects to see if they have 
a preference between FAM-CAM and the Sour Seven. We will also ask 
caregiver subjects what they think of the wording of each item in the Sour 
Seven. If the Sour Seven is preferred, we will also include this assessment in 
the caregiver training video to be developed and discuss how they want this to 
be displayed in the app. 

Study number: s22-01093
Page 47
Version: 6.0     Date: 04/15/2024
CONFIDENTIAL
This material is the property of the NYU Langone Health.  Do not disclose or use except as authorized in writing by the study
sponsor
Behavioral Intervention Template Version: 18 July 2022
3. Caregiver Education Article
a. Caregiver Education Sheet on Delirium (paper/pdf): This existing education 
sheet was developed for both professional and family caregivers. We will ask 
caregiver subjects if anything needs to be changed. 

Study number: s22-01093
Page 48
Version: 6.0     Date: 04/15/2024
CONFIDENTIAL
This material is the property of the NYU Langone Health.  Do not disclose or use except as authorized in writing by the study
sponsor
Behavioral Intervention Template Version: 18 July 2022
b. Caregiver Education Article on Delirium: This is the app version of the 
caregiver education sheet on delirium currently in use in the Aliviado app. We 
will ask caregiver subjects if they think anything needs to be changed.

Study number: s22-01093
Page 49
Version: 6.0     Date: 04/15/2024
CONFIDENTIAL
This material is the property of the NYU Langone Health.  Do not disclose or use except as authorized in writing by the study
sponsor
Behavioral Intervention Template Version: 18 July 2022
4. Caregiver Plan (clinician version): Caregiver subjects will design a care plan 
template for family caregivers focusing on non-pharm interventions.

Study number: s22-01093
Page 50
Version: 6.0     Date: 04/15/2024
CONFIDENTIAL
This material is the property of the NYU Langone Health.  Do not disclose or use except as authorized in writing by the study
sponsor
Behavioral Intervention Template Version: 18 July 2022

Study number: s22-01093
Page 51
Version: 6.0     Date: 04/15/2024
CONFIDENTIAL
This material is the property of the NYU Langone Health.  Do not disclose or use except as authorized in writing by the study
sponsor
Behavioral Intervention Template Version: 18 July 2022
5. Mobile push notification. The screenshot below shows our test push notification. The 
push notification messages to send to Aim 2 caregiver subjects will be developed 
according to feedback from the Aim 1 co-design workshop. In cases where push 
notifications are not feasible or cannot be delivered, SMS text messaging will serve 
as an alternative method to convey motivational messages to caregiver subjects.

Study number: s22-01093
Page 52
Version: 6.0     Date: 04/15/2024 
 
 
CONFIDENTIAL 
This material is the property of the NYU Langone Health.  Do not disclose or use except as authorized in writing by the study 
sponsor 
Behavioral Intervention Template Version: 18 July 2022
6. Sample communication guides: 
The communication guides will be revised according to caregiver feedback. 
We will also ask caregiver subjects if they would prefer to receive this 
information in the app and if so, how this information should be displayed.  
i.
Probable Delirium 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Communication Guide: Probable Delirium 
[I am/This caregiver is] in a research study to learn how to recognize symptoms of 
delirium and apply non-pharmacological strategies to reduce the risk of delirium or 
manage related symptoms in [my/their] loved one with dementia. [I am/The 
caregiver is] encouraged to practice using the Family Confusion Assessment 
Method (FAM-CAM), a valid, informant-administered delirium assessment 
instrument, to screen for potential delirium. According to the FAM-CAM, [my 
spouse/my partner/my parent/my friend/my relative/your patient] has an acute 
change in status and likely has delirium.  [He/she] demonstrates the following 
delirium symptoms:  
 Symptom A 
 Symptom B 
 Symptom C 
(If applicable] [I have/This caregiver has] developed a care plan with the following 
recommended non-pharmacological strategies based on [my/their] loved one’s 
delirium risk factors:  
 Strategy A 
 Strategy B 
 Strategy C 
When the FAM-CAM is positive, a formal clinical assessment performed by the 
patient’s medical provider is required to diagnose or rule out delirium. [Therefore, I 
would like you to examine my loved one’s condition.] 
Note. Please call 911 if there is a medical emergency. If you have any questions or 
concerns about this information guide, please contact the Aliviado Support Center 
at Aliviado.dsd.caregiving@nyu.edu and we will forward your questions/concerns to 
an appriate Aliviado team member to respond within 2 business days in a secure 
email. Please do not include any personal identifiers of the patient (name, date of 
birth, medical record number, etc.) in your email to the Aliviado Support Center. If 
you or your provider needs to call about the study, you can find the PIs’ phone 
numbers in the consent form.  

Study number: s22-01093
Page 53
Version: 6.0     Date: 04/15/2024 
 
 
CONFIDENTIAL 
This material is the property of the NYU Langone Health.  Do not disclose or use except as authorized in writing by the study 
sponsor 
Behavioral Intervention Template Version: 18 July 2022
ii.
Deprescribing 
Communication Guide: Deprescribing  
A review of your loved one’s medications might suggest that the following 
medication(s) may increase your loved one’s risk for delirium. You might want to 
discuss it further with your loved one’s health care provider. You must NOT 
make any changes to your loved one’s medications without first consulting 
your loved one’s healthcare provider.  
 [Medication X] 
Some medications that used to work well may not have the same benefits, or can 
even become harmful, as one gets older. This is because older bodies respond to 
and process medications differently. Moreover, when an individual takes multiple 
medications, they may interact with one another, and the side effects can add up.  
Please note that the Aliviado DSD Caregiving Mastery Program focuses on 
prevention (risk reduction), early detection, and non-pharmacological management 
of delirium symptoms. We provide this medication review because certain 
medications tend to cause or worsen delirium in older adults. The content of this 
guide is for informational purposes only and is not medical advice. Any 
medical and medication-related decisions should be made between you, your 
loved one, and your loved one’s healthcare provider.  
Questions that you may want to ask in discussion with your loved one’s healthcare 
provider:   
 
What matters most to you and your loved one? 
 
What condition does [Medication X] treat in your loved one? 
 
Is the condition treated by [Medication X] still ongoing? 
 
What options do you have if the condition is still ongoing and require treatments? 
 
What can you expect if [Medication X] is reduced or stopped in your loved one? 
 
Are there any risks if [Medication X] is reduced or stopped in your loved one? 
 
How do you feel about these options?
The content of this communication guide has been reviewed by the study team’s 
geriatric pharmacotherapy consultant. Please call 911 if there is a medical 
emergency. If you have any questions or concerns about the information provided 
in this guide, please contact the Aliviado Support Center at 
Aliviado.dsd.caregiving@nyu.edu and we will forward your questions/concerns to 
an appropriate study team member to respond within 2 business days in a secure 
email. Please do NOT include any personal identifiers of [your loved one/the 
patient], such as name, date of birth, medical record number, etc., in your email to 
the Aliviado Support Center. If you or your provider needs to call the study PIs, you 
can find the PIs’ phone nubmers in the consent form.   

Study number: s22-01093
Page 54
Version: 6.0     Date: 04/15/2024 
 
 
CONFIDENTIAL 
This material is the property of the NYU Langone Health.  Do not disclose or use except as authorized in writing by the study 
sponsor 
Behavioral Intervention Template Version: 18 July 2022
Attachment B: Publication Policy
Aliviado Health 
Team Authorship Guidelines 
Authorship of Manuscripts* 
Aliviado Health research team members should participate in the writing of papers
according to the guidelines of the International Committee of Medical Journal Editors 
(ICMJE; see below). Those who participate in conception and design, analysis and 
interpretation of data, drafting of the manuscript, critical revision of the manuscript 
relating to important intellectual content, and final approval of the manuscript should be 
included as authors. 
Provision of study material or patients; collection and assembly of data; provision of 
administrative, technical, or logistic support; and obtaining funding do not necessarily 
merit authorship but should be considered on a case-by-case basis, especially when 
other contributions are included. 
 
Honorary authorship may be considered. 
The PI(s) will oversee the assignment of authorship to ensure that recognition of 
authorship is distributed fairly among study investigators and team members and not 
dominated by any one individual. 
Authorship 
a. Order of authorship shall be agreed upon, by team members planned to be 
involved in developing a manuscript based on their proposed contribution prior to 
beginning the drafting process. The PI(s) will review and approve this order. 
b. All persons eligible for authorship according to the guidelines of the ICJME will be 
listed on the journal title page with the designation that these authors are writing 
on behalf of the study investigators, indicated by including the tag line “and the 
XXXX Investigators” at the end of the author list. 
b.
For journals that limit the number of journal title page authors, manuscripts will be
authored under the byline “The XXXX Investigators.” In this case the Writing
Group will be listed in the appendix in the order as approved by the PI(s). 
c. Persons who have contributed to the completion of the study, but do not meet 
criteria for authorship, will be listed in the Acknowledgements Section in 
alphabetical order by site. 
d. If individuals do not provide their proposed contribution to the manuscript or are 
not timely in completing their contribution, the PI(s) at their discretion may change 
authorship order or remove from authorship if the individual no longer meets 
ICJME criteria. 
 
Adjudication of Disagreements 
a. Disagreements regarding authorship, which cannot be resolved by the team, will 
be resolved by the PI(s). 
 
 
 
Funding Statements 

Study number: s22-01093
Page 55
Version: 6.0     Date: 04/15/2024 
 
 
CONFIDENTIAL 
This material is the property of the NYU Langone Health.  Do not disclose or use except as authorized in writing by the study 
sponsor 
Behavioral Intervention Template Version: 18 July 2022
Funding acknowledgment need to be included on all presentations and publications.
Please see the language below: 
o Funding Acknowledgement: This work was (partially) supported through a XXX Institute Award 
(Award #) 
*Guidelines apply to all manuscripts, posters, oral presentations, and abstracts. 
All manuscripts, posters, oral presentations, and abstracts must be vetted by the PI(s) prior to 
submission: 
• At least one week prior for posters and oral presentations 
• At least one month prior for manuscripts 
The PI(s) must be notified of all accepted manuscripts, posters, oral presentations, or 
abstracts. 
Writing Group Policies 
In order to ensure that all team members have the opportunity to participate and be 
recognized in the Aliviado Health papers, writing groups will usually include appropriate 
investigators, staff and students. Investigators interested in being part of a writing group 
should submit comments and/or suggestions during the proposal development. Writing 
Group membership should be established before submitting the final proposal. 
Usually the manuscript proposer will be designated as the Writing Group Facilitator and 
first author of the paper. They will receive written notification of all Writing Group 
members and their responsibilities as facilitator (see below). 
The Writing Group Facilitator is responsible for all phases of manuscript preparation, from 
conception through publication. These responsibilities include: 
a. Preparation of outlines, the identification of data analyses needed, and submission 
of interim status reports to the Writing Group; 
b. Assignment of tasks to Writing Group members with clear deadlines for completion 
of these tasks and determination that the tasks are completed on schedule; 
c. Preparation and circulation of drafts for approval by each member of the Writing 
Group before submission of a Penultimate Draft to the PI(s) before submission to a journal; 
d. Determination of the order of authorship on the manuscript. A major criterion will 
be the effort and contribution made by each member of the Writing Group in the 
preparation of the manuscript; 
e. Choice of a journal to which the manuscript will be submitted in consultation with 
the Principle Investigator; 
f. 
Correspondence with coauthor and journal editors. 
The Writing Group Facilitator should contact each member of the Writing Group to 
discuss the outline of the paper, data analysis plan, and the responsibilities and 
assignments for each member. Members of the Writing Group are responsible for 
performance of tasks assigned by the Facilitator within the allotted time period. Each 
member is expected to actively participate in the preparation of the manuscript. If a Writing Group 
member does not accomplish the tasks assigned to him/her and has 
not contributed to the manuscript, he/she may be removed from the Writing Group. 
ICMJE Authorship Guidelines 
The International Committee of Medical Journal Editors has recommended the following 

Study number: s22-01093
Page 56
Version: 6.0     Date: 04/15/2024 
 
 
CONFIDENTIAL 
This material is the property of the NYU Langone Health.  Do not disclose or use except as authorized in writing by the study 
sponsor 
Behavioral Intervention Template Version: 18 July 2022
criteria for authorship; these criteria are still appropriate for those journals that distinguish authors 
from other contributors. 
 
a.
Authorship credit should be based on 1) substantial contributions to conception and design, or 
acquisition of data, or analysis and interpretation of data; 2) drafting the article or revising it 
critically for important intellectual content; and 3) final approval of the version to be published. 
Authors should meet conditions 1, 2, and 3. 
b. When a large, multi-center group has conducted the work, the group should identify the 
individuals who accept direct responsibility for the manuscript (3). These individuals should fully 
meet the criteria for authorship defined above and editors will ask these individuals to complete 
journal-specific author and conflict of interest disclosure forms. When submitting a group author 
manuscript, the corresponding author should clearly indicate the preferred citation and should 
clearly identify all individual authors as well as the group name. Journals will generally list other 
members of the group in the acknowledgements. The National Library of Medicine indexes the 
group name and the names of individuals the group has identified as being directly responsible 
for the manuscript. 
c. Acquisition of funding, collection of data, or general supervision of the research group, alone, 
does not justify authorship. 
d. All persons designated as authors should qualify for authorship, and all those who qualify should 
be listed.  
e. Each author should have participated sufficiently in the work to take public responsibility for 
appropriate portions of the content. 
Some journals now also request that one or more authors, referred to as “guarantors,” 
be identified as the persons who take responsibility for the integrity of the work as a 
whole, from inception to published article, and publish that information. Increasingly, authorship 
of multi-center trials is attributed to a group. All members of the group who are named as authors 
should fully meet the above criteria for authorship. The order of authorship on the byline should 
be a joint decision of the coauthors. Authors should be prepared to explain the order in which 
authors are listed. 
Source: www.icmje.org 

Study number: s22-01093 
 
page 1 
Version: 1.0 
CONFIDENTIAL 
This material is the property of the NYU School of Medicine and Langone Health.  Do not disclose or use except as authorized in writing by the study sponsor 
Drug/Device Template Version: 11 Jan 2019 
Attachment C: Schedule of Events 
Aim 1/Phase 1 Codesign Workshop 
Assessment 
Screening 
Visit  
Enrollment 
Visit (Week 0) 
Group 
Session 1 
Group 
Session 2 
Group 
Session 3 
Group 
Session 4 
Group 
Session 5 
Optional preliminary 
usability testing 
Informed Consent Form   
  
  
  
  
  
  
  
  
Demographics 
  
  
  
  
 
 
 
 
DSD Exposure/Familiarity 
with DSD   
  
 
  
  
 
 
 
 
Health literacy 
 
  
  
  
 
 
 
 
Comfort with Technology 
 
  
 
  
 
 
 
 
Email session materials 
and reminder to confirm 
attendance (3 days before)
 
 
  
  
  
  
  
  
Email reminder to confirm 
attendance 
(the 
day 
before) 
 
 
  
  
  
  
  
  
Inform waitlist caregivers of 
codesign session openings 
(Yes; NA, there are no 
openings) 
 
 
  
  
  
  
  
 
Phone reminder (>=3hrs 
before the session) 
 
 
  
  
  
  
  
  
Take Attendance  
 
 
  
  
  
  
  
 
Review Session Agenda/ 
Objectives 
and 
Ground 
Rules 
 
 
  
  
  
  
  
  
Obtain 
Permission 
for 
Audio/Video Recording
 
 
  
  
  
  
  
  
Gift Card 
  
 
  
  
  
  
  
 
Brief Post Session Survey 
  
 
  
  
  
  
  
 
Note. Screening and Enrollment may happen during the same visit if the caregiver is eligible and wants to proceed with data collection.  

Study number: s22-01093 
 
Page 2 
Version: 6.0     Date: 04/15/2024 
 
 
CONFIDENTIAL 
This material is the property of the NYU Langone Health.  Do not disclose or use except as authorized in writing by the study sponsor 
Behavioral Intervention Template Version: 18 July 2022 
Aim 2/Phase 2 Feasibility Trial 
Assessment 
Screening  
visit 
Enrollment Visit 
(Week 0) 
Visit 2 
Visit 3 
Informed Consent Form   
  
 
 
 
Demographics 
  
  
 
 
Health Literacy 
 
  
 
 
Comfort with Technology 
 
  
 
 
Dementia Severity 
 
  
 
 
Behavioral and Psychological Symptoms of 
Dementia 
 
  
 
 
Caregiver Strain  
 
  
 
  
Caregiver Depression 
 
  
 
  
Caregiver Burden 
 
  
 
  
Caregiving Self-Efficacy 
 
  
 
  
Caregiver Delirium Knowledge  
 
  
  
  
DSD Caregiving Mastery 
 
  
  
  
Program Satisfaction  
 
 
 
  
App Usability 
 
 
 
  
 
Note. Screening and Enrollment may happen during the same visit if the caregiver is eligible and wants to proceed with data collection.  
DSD=delirium superimposed on dementia 
 
 

Study number: s22-01093 
 
page 1 
Version: 1.0 
CONFIDENTIAL 
This material is the property of the NYU School of Medicine and Langone Health.  Do not disclose or use except as authorized in writing by the study sponsor 
Drug/Device Template Version: 11 Jan 2019 
 
Attachement D: Sample Push Notification/SMS Text Messages 
 
 
Welcome to Aliviado Dementia Care! Access the Learning Center here and start your training today! 
 
Check out our tools to help you be a better advocate for your family member or friends with dementia! 
 
Click here to get some help to begin your online training in the Aliviado Dementia Care Delirium Expert Program for Family and 
Friends!  
 
Keep up the great work! You've made it through at least the first two videos. Let's make it through at least Video X this week. 
 
Remember to catch up on the online training videos! Take the next 5 minutes of your time to complete Video X.  
 
Assessing delirium symptoms systematically can lead to improved care. Assess the symptoms with FAM-CAM or SOUR-
SEVEN today! 
 
You're really moving! Take the next 10 minutes of your time to get through one more video this week. 
 
We're starting week 2 of the Aliviado Dementia Care Delirium Expert Program for Family and Friends! Remember to complete 
the remaining videos. 
 
Let's get a few more videos done this week. At least through Video X. Soon you'll be an Aliviado Dementia Care Delirium 
Caregiving Expert! 
 
 Great job completing your Aliviado training! Make sure to save a copy of your certificate of completion and apply what 
you've learned with your family member or friend. 
 
Recognizing delirium symptoms can be challenging. Use FAM-CAM to assess and support your family member or friend. 
 
Check out our tools to help you be a better advocate for your family member or friend with dementia. Click to find them in the 
Aliviado app! 
 
Have you implemented any Aliviado care plans? 
 
What Aliviado assessment tools have you used?