Adapting and Implementing the I-HoME Intervention in Caregivers of Patients With ADRD
Phase: NA
Conditions: Caregiver Burden
Sponsor: Weill Medical College of Cornell University

  
Page #   
 
 
 
 
Adapting and implementing the I-HoME intervention in caregivers of patients with ADRD 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
NCT 06488157  
 
Protocol Approved on 6/26/2024 
 

IRB Protocol #: 23-01025643 
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TITLE:  Adapting and implementing the I-HoME intervention in caregivers of patients with ADRD 
 
IRB Protocol #: 23-01025643 
Version Date: June 3, 2024 
Funding Source(s): National Institute on Aging 
 
Principal Investigator: 
 
Veerawat Phongtankuel, MD, MS 
525 East 68th St., 14th Floor, Box 39 
Tel (212) 746-1501 
Fax (212) 746-4888 
 
 
 
vep9012@med.cornell.edu 
 
Co-Investigators: 
 
Taeyoung Park 
 
 
525 E. 68th St., 14th Floor Box 39 
 
 
(212) 746-1758 
 
 
(212) 746-4888  
 
 
tap4003@med.cornell.edu 
  
 
External Collaborator(s): 
 
N/A 
  
 
 
Statistician: N/A 
 
 
 
 
 
 
 
 
Participating Sites:   
Weill Cornell Medicine 
Veerawat Phongtankuel, MD, MS 
525 East 68th St., 14th Floor, Box 39 
Tel (212) 746-1501 
Fax (212) 746-4888 
 
 
 
vep9012@med.cornell.edu 
 
 

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Table of Contents 
LIST OF ABBREVIATIONS ...................................................................................................... IV 
1. PROTOCOL SUMMARY........................................................................................................ 1 
1.1 
Study Objectives ............................................................................................................. 2 
1.1.1 Objectives 
2 
1.1.2 Hypotheses / Research Questions 
2 
2. BACKGROUND AND SIGNIFICANCE .................................................................................. 2 
3. STUDY DESIGN AND METHODS ......................................................................................... 3 
3.1 Overall Design ..................................................................................................................... 3 
3.2 Interviews, Focus Groups, Surveys, and/or Observations ................................................... 5 
4. STUDY DESIGN .................................................................................................................... 5 
4.1 Study Population – All Aims ................................................................................................. 5 
4.2 Inclusion Criteria – All Aims ................................................................................................. 5 
4.3 Exclusion Criteria – All Aims ................................................................................................ 6 
ADRD Patient criteria ................................................................................................................ 6 
4.4 Strategies for Recruitment and Retention ............................................................................ 6 
5. REGISTRATION PROCEDURES .......................................................................................... 7 
5.1 Subject Registration (WCM only) ......................................................................................... 7 
5.2 Subject Registration (Sub-sites) ........................................... Error! Bookmark not defined. 
6. STUDY PROCEDURES ......................................................................................................... 7 
6.1 Schedule of Assessments ................................................................................................... 7 
Table 1. Schedule of trial events ............................................................................................... 7 
7. DATA REPORTING / REGULATORY CONSIDERATIONS .................................................. 7 
7.1 Data Collection .................................................................................................................... 7 
7.1.1 REDCap 
8 
7.2 Regulatory Considerations .................................................................................................. 8 
7.2.1 Institutional Review Board/Ethics Committee Approval 
8 
7.2.2 Ethical Conduct of the Study 
8 
7.2.3 Informed Consent 
9 
7.2.4 Compliance with Trial Registration and Results Posting Requirements 
9 
7.2.5 Record Retention 
9 
8. STATISTICAL CONSIDERATIONS ....................................................................................... 9 
9. REFERENCES ..................................................................................................................... 10 
 
 
 
 
 
 
 

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Confidentiality Statement 
 
This document is confidential and is to be distributed for review only to investigators, potential 
investigators, consultants, study staff, and applicable independent ethics committees or institutional 
review boards. The contents of this document shall not be disclosed to others without written 
authorization from WCM. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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List of Abbreviations 
 
 
 
ADRD 
Alzheimer’s Disease and related dementia 
CFR 
Code of Federal Regulations 
CTSC 
Clinical Translational Science Center  
FDA 
Food and Drug Administration 
FAST 
Functional Assessment Staging Tool  
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act of 1996 
I-HoME 
Improving Home hospice Management of End-of-life issues through 
technology 
ICF 
Informed Consent Form 
IRB 
Institutional Review Board 
PHI 
Protected Health Information 
PI 
Principal Investigator 
REDCap 
Research Electronic Data Capture 
WCM 
Weill Cornell Medicine 
 
 

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1. Protocol Summary  
 
Full Title: Adapting and implementing the Improving Home hospice Management of End-of-life issues through 
technology (I-HoME) intervention in caregivers of patients with Alzheimer’s Disease and related dementias 
(ADRD). 
Short Title:                            I-HoME and ADRD 
Principal Investigator:  
Veerawat Phongtankuel, MD, MS 
Study Description:  
Aim 1 of the protocol is to adapt the I-HoME intervention for caregivers of ADRD 
patients with advanced illness by leveraging stakeholder input through interviews 
with providers (n=30) and caregivers (n=30) of ADRD patients. Using an iterative 
user-centered design approach, the data collected will inform adaption of the I-
HoME manual, protocol, and data collection instruments to address the care needs 
of patients with ADRD and their caregivers. Aim 2 of the proposal is to pilot test 
the adapted I-HoME intervention with family caregivers (n=30) of ADRD patients 
with advanced illness. Data will be collected regarding intervention feasibility and 
acceptability. Secondary measures will consist of ADRD symptom assessment 
tools, caregiver burden, caregiver anxiety and depression scores, and caregiver 
satisfaction. 
 
Sample Size: 
 
N = 90 
Enrollment: 
 
This study will enroll 90 subjects and screen up to 300 subjects.  
Study Population: 
 
Healthcare professionals (Aim 1 only) and adult caregivers ≥18 years old and 
<105 years old who provide care to a patient with advanced ADRD (Aims 1 and 
2). 
Enrollment Period:  
2 years 
Study Design: 
 
Aim 1 will implement an iterative user-centered design approach through 
qualitative interviews. The data collected will inform adaption of the I-HoME 
manual, protocol, and data collection instruments to address the care needs of 
patients with ADRD and their caregivers. Aim 2 will be a pilot study looking at 
feasibility and acceptability of implementing the I-HoME intervention for caregivers 
of ADRD patients. 
Description of Sites 
Facilities Enrolling 
Participants: 
 
Participants will be recruited from Weill Cornell’s Center on Aging (Aims 1 and 2) 
and from the hospice medical director website (Aim 1 only). 
Study Duration: 
 
2/1/2025 
Participant Duration: 
Aim 1 – 4 months  
 
 
Aim 2 - 1 year 
Primary Objective: 
Aim 1 - to adapt the I-HoME intervention for caregivers of ADRD patients with 
advanced illness  
Aim 2 - To evaluate the feasibility and acceptability of implementing the I-HoME 
intervention for caregivers of ADRD patients.  
Secondary Objectives: 
N/A 
Exploratory Objectives: 
N/A 

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Primary Endpoints: 
Feasibility outcomes are measured by examining the percentage of caregiver 
participants who enroll in the study and the percentage of caregiver participants 
who complete the telehealth visits. 
 
Secondary Endpoints: 
Secondary endpoints will consist of ADRD symptom assessment tools (Doloplus-
2 scale and behavioral and psychosocial symptoms of dementia (BPSD) scale), 
caregiver burden (Zarit Burden Interview – short version), and caregiver anxiety 
(General Anxiety Disorder-7 scale) and depression (Patient Health 
Questionnaire-8 scale) scores. 
 
1.1 Study Objectives 
 
 
1.1.1 Objectives  
Aim 1: To adapt the I-HoME intervention for caregivers of ADRD patients with advanced illness by 
leveraging stakeholder input through interviews with providers (n=30) and caregivers (n=30) of 
ADRD patients. 
Aim 2: To pilot test  the adapted I-HoME intervention with family caregivers (n=30) of ADRD 
patients with advanced illness. 
1.1.2 Hypotheses / Research Questions 
We hypothesize that implementing the adapted I-HoME intervention will be feasible and acceptable 
to participants.   
 
2. Background and Significance 
Use of palliative care services in the US has risen steadily over the past few decades, with over 80% of 
hospitals having a palliative care team1 and over 50% of Medicare decedents receiving hospice services.2 In the 
1980s, most palliative care services were delivered to cancer patients.3 However, there has been a marked shift 
in the types of patients receiving these services today. In particular, the number of patients with Alzheimer’s 
Disease and Related Dementias (ADRD) who need and/or receive End-of-Life (EoL) care has increased steadily. 
Dementia is now the fifth leading cause of death4 among older adults, and of all patients receiving hospice care, 
45% have a primary or secondary dementia diagnosis.5 Yet, research focused on developing and testing services 
and models to best meet the palliative care needs of ADRD patients and their caregivers remains modest. As a 
result, multiple organizations have called for research to improve palliative care in affected patients and their 
caregivers.6–8 
ADRD patients with advanced illness present unique challenges for care provision when compared to 
patients with non-dementing terminal illnesses. One notable challenge is an inability to clearly communicate their 
symptoms or care needs. Patients are also more likely to exhibit behavioral and psychosocial symptoms of 
dementia (BPSD).9 These issues pose a challenge for caregivers and providers with respect to assessing and 
managing symptoms and providing optimal palliative care. Furthermore, caregivers of patients with (vs. without) 
ADRD that are approaching the EoL are more likely to suffer from depression, anxiety, and poor physical 
health.10–12 Therefore, supporting family caregivers of ADRD patients with advanced illness who need 
palliative/EoL care services is essential for their well-being and for the well-being of affected patients.13 
To date, little research has focused on finding solutions to improve palliative/EoL care outcomes among 
ADRD patients with advanced illness and their caregivers. In a recent systematic review6 examining ADRD 
patients receiving hospice care, the authors identified only 10 intervention studies, with 3 reporting ambiguous 
objectives or equivocal outcomes. In addition, many providers lack formal training in how to deliver palliative care 
to ADRD patients14 and evidence-based practices are lacking.15 Given the dearth of high quality evidenced-
based solutions, ADRD patients with advanced illness and their caregivers may receive suboptimal palliative 
care, leading to unwanted outcomes such as burdensome care transitions16,17, especially among African 
American and Latinx patients.17 
The Improving Home hospice Management of End-of-life issues through technology (I-HoME) intervention 
is a caregiver-directed intervention that supplements existing care with video visits and education provided by a 
palliative trained nurse practitioner. Visits with a nurse practitioner focus on assessing and treating distressing 

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patient symptoms and supporting caregivers through education around symptom management. However, I-
HoME was not designed to account for the special care needs and challenges of ADRD patients. This protocol 
aims to adapt the I-HoME intervention for caregivers of ADRD patients with advanced illness. 
 
3. Study Design and Methods 
 
3.1 Overall Design 
 
Aim 1 
A user-centered design approach will be incorporated and involve healthcare providers and caregivers of 
patients with ADRD. 
For the first phase of Aim 1, the study will recruit (n=30) geriatricians and palliative care providers at Weill Cornell 
Medicine along with hospice medical directors from a national registry. In addition, caregivers (n=30) of ADRD 
patients with advanced illness will be recruited from Weill Cornell Medicine. Data collected in this phase will be 
used to adapt the current version of the I-HoME intervention. 
For the second phase of Aim 1, as part of the iterative user-centered design process, participants from the first 
phase will be recruited to provide additional feedback (see Follow-up Questionnaires with submitted data 
collection material) on the adapted version of I-HoME to further refine the intervention.  
 
Study population 
Healthcare providers will be recruited from Weill Cornell Medicine and a hospice medical director website 
(hmdcb.org). Caregivers of ADRD patients will be recruited through referrals from providers at the Center on 
Aging and the House Call program at Weill Cornell Medicine. 
 
Recruitment 
For recruitment of healthcare providers, an email will be sent out to clinicians detailing the study. A member 
of the research team will follow up with interested participants and schedule a time to obtain informed consent 
and conduct an interview (in-person, virtually).  
For recruitment of caregivers, the research team will obtain a list of potential caregiver participants based on 
the patient’s dementia diagnosis from the electronic medical record. ADRD will be defined by using a modified 
list of the 22 International Classification of Diseases - Tenth Revision (ICD-10) diagnosis codes endorsed by the 
Centers for Medicare & Medicaid Services (CMS) for ADRD.18 Once a list of patients is generated, the research 
team will then collaborate with the patient’s provider at the Center on Aging and the House Call program to 
identify ADRD patients with advanced illness. The research team will use the Functional Assessment Staging 
Tool (FAST) scale for dementia to identify qualified participants. The research team will recruit caregivers of 
patients who are at a stage 7a-f on the FAST scale and have not had a medical complication over the past year. 
Caregivers of patients that meet the study criteria will be contacted by phone and informed about the study. 
Interested caregivers will be scheduled to meet (in-person, virtually) where informed consent will be obtained 
and an interview will be administered. Participant inclusion criteria include, (1) age 18 years or older, (2) providing 
care to an ADRD patient with advanced illness, and (3) English speaking.  
Participants recruited in Aim 1 will be compensated with a $75 gift certificate. 
 
Data collection 
An open-ended interview guide will be developed by the research team. The objectives of the interview for 
the first phase of Aim 1 are (1) to identify and understand the challenges (e.g., symptom management and care 
needs) in caring for ADRD patients and their caregivers; (2) to describe the current I-HoME protocol and 
intervention to participants; (3) to understand whether the current I-HoME intervention would be feasible and 
acceptable to caregivers of ADRD patients; and (4) to obtain input on adapting/modifying the current intervention 
to meet the symptom management and care needs of ADRD patients with advanced illness. 

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For the second phase of Aim 1, a subset of participants from the first phase will be asked to review the 
adapted I-HoME materials and provide feedback on the various intervention components which include the 
manual, protocol, content, and data collection instruments. 
Aim 2 
Aim 2 will be a pilot study examining the feasibility and acceptability of an adapted I-HoME intervention for 
caregivers of ADRD patients with advanced illness. 
 
Study population 
This study will recruit caregivers from the Center on Aging and the House Call program at Weill Cornell 
Medicine through referrals from providers. 
 
Recruitment 
Caregivers of ADRD patients with advanced illness will be identified from the medical records and screened 
by their provider. The caregiver will then be contacted by phone and informed about the study. Interested 
caregivers will be scheduled a time for an interview (virtually or in-person) where informed consent will be 
obtained. Participant inclusion criteria include, (1) age 18 years or older, (2) the family caregiver of the patient, 
(3) providing any sort of caregiving on a regular basis (at least weekly), (4) English speaking, and (5) have access 
to an electronic device with cellular data or Internet connection to access the telehealth platform. 
After the caregiver is enrolled, a member of the research team will go over how to use their personal device 
to conduct video visits with the nurse practitioner. Software by Doxy.me19 will be used to conduct HIPAA 
compliant video visits. 
 
I-HoME intervention 
The current I-HoME protocol involves video visits with a nurse practitioner for up to six visits to address 
symptom management and care needs. Nurse practitioners delivering the intervention go through a training 
session that familiarizes them with the I-HoME protocol. The protocol provides a framework for 
assessing/evaluating common patient symptoms and developing a treatment plan dependent upon the 
symptoms uncovered. After each visit, a summary of the treatment plan will be relayed to the patient’s care team 
at the Center on Aging and/or the House Call program. 
 
Data collection 
Patient variables will be collected from 
the electronic medical record and are 
detailed in Table 1. Validated surveys and 
questions will be administered to the 
caregiver via phone by a research 
assistant. Caregivers will be assessed on 
the measures listed in Table 2 at various 
timepoints in the intervention. Participants 
will be compensated with a $25 gift card each time they complete an initial, within study, and post-intervention 
survey phone call. 
 
Table 2. Measures administered at each time point to caregivers. 
Baseline measures 
Within study measures  
(After each visit) 
Post-intervention measures  
(After final visit) 
Age 
BPSD (NPI5) 
BPSD (NPI25) 
Gender 
Pain (Doloplus-26) 
Depression (PHQ-88)  
Race/ethnicity 
Burden (ZBI-short version7)  
Anxiety (GAD-79) 
Religion/Spirituality 
Depression (PHQ-88)  
Acceptability measures 
Education 
Anxiety (GAD-79)  
Pain (Doloplus-26) 
Relationship to patient 
Software issues  
Burden (ZBI-short version7)  
Hours providing care to patient 
Hardware issues 
Software issues  
Occupation 
 
Hardware issues 
Income 
 
Caregiving Preparedness3 
Table 1. Variables collected from the patient’s electronic medical record  
Demographic data 
Post-intervention measures  
Age 
Number of office visits at Weill Cornell  
Gender 
Number of phone calls at Weill Cornell 
Race/ethnicity 
Hospitalization at Weill Cornell during intervention 
ADRD diagnosis code 
Enrolled into hospice care during intervention (yes/no) 
Comorbidities 
 
Medications 
 
DNR/DNI status at 
time of enrollment 
 

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Marital Status 
 
Caregiving Competence4 
Patient residence 
 
SF-12 Health Survey2 
Paid caregivers for patient 
 
Family Satisfaction with Advanced Cancer Care10 
Number of caregivers for patient 
 
 
Caregiving responsibilities 
 
 
Feeling of choice in taking on 
caregiving responsibilities 
 
 
Availability of another caregiver if the 
participant is not available 
 
 
ADL/IADL 
 
 
Positive Aspects of Caregiving1 
 
 
Formal Care and Services questions 
 
 
SF-12 Health Survey2 
 
 
Caregiving Preparedness3 
 
 
Caregiving Competence4 
 
 
1Positive aspect of caregiving20 
5Neuropsychiatric Inventory 
 
8Patient Health Questionnaire-826 
2SF-12 Health Survey21 
 
6Doloplus-224 
 
 
 
9General Anxiety Disorder-727 
3Caregiving preparedness22 
7Zarit Burden Interview–short version25    
10Family Satisfaction with Advanced Cancer Care28 
4Caregiving competence23 
 
 
3.2 Interviews, Focus Groups, Surveys, and/or Observations  
 
A. Administration 
For Aim 1 of the study, participants will be interviewed for up to 60 minutes to provide feedback on 
the I-HoME intervention. The same participants will be contacted within 2 months to provide 
additional feedback on the adapted version intervention; a follow-up questionnaire has been 
submitted to the IRB.  
 
For Aim 2 of the study, questions will be administered to participants (family caregivers) at the first 
visit and within a week of completion of each televisit. Data from the subject’s medical record will be 
obtained that are relevant to the study objectives (Table 2). 
B. Study Instruments 
For Aim 1, demographic measures will be collected from participants. A semi-structured interview 
guide will be used to conduct interviews, with open-ended questions. 
 
For Aim 2, baseline demographic measures will be collected from the family caregiver and from the 
patient’s medical record (see Table 1). Caregivers will be administered baseline, in-study, and post-
intervention measures as outlined in Table 2. 
4. Study Design 
 
4.1 Study Population – All Aims 
 
Caregiver Participants: Family caregivers of ADRD patients who meet the following criteria: age ≥ 65 
years old and < 105 years old with advanced ADRD (more details below) 
 
Provider Participants: Healthcare providers from Weill Cornell Medicine or Hospice medical directors 
 
4.2 Inclusion Criteria  
 
 
Aim 1 
 
Healthcare provider criteria 

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• 
age 18 years or older 
• 
a practicing medical provider (i.e., physician, nurse practitioner, physician assistant) 
• 
experience working with caregivers of patients with ADRD 
• 
English speaking. 
 
ADRD LAR criteria 
• 
age ≥ 18 years old and < 100 years 
• 
English speaking  
• 
Providing care to an ADRD patient who is age ≥ 65 years old and < 105 years 
 
 
 
Aim 2 
ADRD family caregiver criteria 
• 
age ≥ 18 years old and < 100 years 
• 
English speaking  
• 
Providing care to an ADRD patient who is age ≥ 65 years old and < 105 years that is a stage 7a-f on 
the FAST scale 
• 
Has access to an electronic device with cellular data or Internet connection 
 
4.3 Exclusion Criteria – All Aims 
 
Healthcare provider criteria 
• 
Non-English speaking 
• 
<18 years old 
 
ADRD LAR/family caregiver criteria 
• 
Non-English speaking 
• 
<18 years old or >100 years old 
• 
Does not provide care to an ADRD patient who is age ≥ 65 years old and < 105 years that is a stage 
7a-f on the FAST scale 
• 
Does not have access to an electronic device with cellular data or Internet connection 
 
4.4 Strategies for Recruitment and Retention 
 
 
Participants will consist of healthcare providers and caregivers of patients with a history of advanced 
ADRD. Recruitment of participants will be conducted at Weill Cornell Medicine’s Center on Aging (Aim 1 
and Aim 2) and the hospice medical director website (Aim 1 only). 
 
Patient referral will be obtained from providers of the practice. Providers will present an Agree to Contact 
Sheet (included with our IRB submission) when appropriate. Potential participants will be sent a 
recruitment letter by a member of the research team to inquire about participating. We will follow up with 
family caregivers of the patients to whom we’ve sent a recruitment letter, via phone call or e-mail, one 
week following the mailing.   
 
We will not target sample size by gender, race or ethnicity but hope to have a diverse pool of participants. 
We hope to recruit a total of 90 participants and estimate that we will screen 300 potential participants. A 
partial HIPAA waiver for recruitment purposes is requested in the IRB application. After a potential 
caregiver participant has been identified (for Aim 2) via our recruitment methods, study staff will review 

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charts and a study team physician will approve that a potential participant is medically eligible before 
consent and screening occurs. 
 
Participants in Aim 1 will be compensated with a $75 gift card for their participation. Participants in Aim 
2 will be compensated with a $25 gift card after completion of surveys during the duration of the study. 
 
5. Registration Procedures 
 
5.1 Subject Registration (WCM only) 
 
Subjects will be registered within the WRG-CT as per the standard operating procedure for Subject 
Registration.  
 
6. Study Procedures 
 
6.1 Schedule of Assessments  
Table 3. Schedule of trial events 
 
AIM 1 
Pre- Study Time point 1 
Time point 2 
Screening (providers and LARs) 
X 
 
 
Informed Consent 
 
X 
 
Demographic Questions and 
interview 
 
X 
 
Follow up interview for feedback on 
adapted version of I-HoME  
 
 
X 
 
 
Table 4. Schedule of trial events 
 
AIM 2 
Pre- 
Study 
Day 1 
(Study 
Visit) 
Post 
visit #1 
Post 
visit #2 
Post 
visit #3 
Post 
visit #4 
Post 
visit #5 
Post 
visit #6 
Screening (Patient) 
X 
 
 
 
 
 
 
 
Screening (Family caregiver) 
X 
 
 
 
 
 
 
 
Informed Consent 
 
X 
 
 
 
 
 
 
Demographic Questions  
 
X 
 
 
 
 
 
 
Family caregiver survey data 
collection 
 
X 
X 
X 
X 
X 
X 
X 
 
7. Data Reporting / Regulatory Considerations 
 
7.1 Data Collection 
The data collection plan for this study is to utilize REDCap to capture data (Demographic, medical and 
survey data) for all enrolled subjects.  
 

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7.1.1 REDCap 
REDCap (Research Electronic Data Capture) is a free data management software system that is 
fully supported by the Weill-Cornell Medical Center CTSC. It is a tool for the creation of 
customized, secure data management systems that include Web-based data-entry forms, 
reporting tools, and a full array of security features including user and group-based privileges, 
authentication using institution LDAP system, with a full audit trail of data manipulation and export 
procedures. REDCap is maintained on CTSC-owned servers that are backed up nightly and 
support encrypted (SSL-based) connections. Nationally, the software is developed, enhanced, 
and supported through a multi-institutional consortium led by the Vanderbilt University CTSA. 
 
7.2 Regulatory Considerations 
 
7.2.1 Institutional Review Board/Ethics Committee Approval  
 
As required by local regulations, the Investigator will ensure all legal aspects are covered, and 
approval of the appropriate regulatory bodies obtained before study initiation.  
Before initiation of the study at each study center, the protocol, the ICF, other written material 
given to the patients, and any other relevant study documentation will be submitted to the 
appropriate Ethics Committee. Written approval of the study and all relevant study information 
must be obtained before the study center can be initiated or the IP is released to the Investigator. 
Any necessary extensions or renewals of IEC/IRB approval must be obtained for changes to the 
study, such as amendments to the protocol, the ICF, or other study documentation. The written 
approval of the IEC/IRB together with the approved ICF must be filed in the study files.  
The Investigator will report promptly to the IEC/IRB any new information that may adversely affect 
the safety of the subjects or the conduct of the study. The Investigator will submit written 
summaries of the study status to the IEC/IRB as required. On completion of the study, the IEC/IRB 
will be notified that the study has ended.  
 
All agreed protocol amendments will be clearly recorded on a protocol amendment form and will 
be signed and dated by the original protocol approving signatories. All protocol amendments will 
be submitted to the relevant institutional IEC/IRB for approval before implementation, as required 
by local regulations. The only exception will be when the amendment is necessary to eliminate 
an immediate hazard to the trial participants. In this case, the necessary action will be taken first, 
with the relevant protocol amendment following shortly thereafter.  
Once protocol amendments or consent form modifications are implemented at the lead site, Weill 
Cornell Medicine, updated documents will be provided to participating sites. Weill Cornell 
Medicine must approve all consent form changes prior to local IRB submission.  
Relevant study documentation will be submitted to the regulatory authorities of the participating 
countries, according to local/national requirements, for review and approval before the beginning 
of the study. On completion of the study, the regulatory authorities will be notified that the study 
has ended.  
 
7.2.2 Ethical Conduct of the Study  
The Investigators and all parties involved should conduct this study in adherence to the ethical 
principles based on the Declaration of Helsinki, GCP, ICH guidelines and the applicable national 
and local laws and regulatory requirements.  
 

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This study will be conducted under a protocol reviewed and approved by the applicable ethics 
committees and investigations will be undertaken by scientifically and medically qualified persons, 
where the benefits of the study are in proportion to the risks. 
 
7.2.3 Informed Consent 
The investigator or qualified designee must obtain documented consent according to ICH-GCP 
and local regulations, as applicable, from each potential subject or each subject’s legally 
authorized representative prior to participating in the research study. Subjects who agree to 
participate will complete an informed consent process and will be provided a copy of the finalized 
document.   
 
Informed Consent for participants will occur just prior to their screener by in person or remote, 
oral consent methods. A member of the study team will review the ICF document, in-full, with 
each participant in person or by phone or videoconference, emphasizing the key information, 
allowing for questions, and reminding the potential subject that participation is entirely voluntary. 
In person and oral confirmation of consent will be documented by the study team member.   
 
The initial ICF, any subsequent revised written ICF and any written information provided to the 
subject must approved by IRB prior to use. The ICF will adhere to IRB/IEC requirements, 
applicable laws and regulations. 
 
 
7.2.4 Compliance with Trial Registration and Results Posting Requirements  
 
Under the terms of the Food and Drug Administration Modernization Act (FDAMA) and the Food 
and Drug Administration Amendments Act (FDAAA), the Sponsor-Investigator of the trial is solely 
responsible for determining whether the trial and its results are subject to the requirements for 
submission to http://www.clinicaltrials.gov. Information posted will allow subjects to identify 
potentially appropriate trials for their disease conditions and pursue participation by calling a 
central contact number for further information on appropriate trial locations and trial site contact 
information. 
 
7.2.5 Record Retention 
 
Essential documents are those documents that individually and collectively permit evaluation of 
the study and quality of the data produced.  After completion of the study, all documents and data 
relating to the study will be kept in an orderly manner by the Investigator in a secure study 
file.  Essential documents should be retained for 2 years after the final marketing approval in an 
ICH region or for at least 2 years since the discontinuation of clinical development of the IP. In 
addition, all subject medical records and other source documentation will be kept for the maximum 
time permitted by the hospital, institution, or medical practice.   
 
8. Statistical Considerations 
Aim 1 
Audio recordings from interviews will be transcribed verbatim. Content analysis29, a method for classifying 
verbal and behavioral data into categories of similar meaning, will be used to analyze data. A deductive 
approach will be implemented. During open coding, short sections of text representing discrete concepts will 
be identified from transcripts and tagged with a code. This will be followed by focused coding, which involves 
comparing codes within and across interviews. Lastly, axial coding, where codes are compared between 
transcripts to develop a set of categories and/or themes, will be the third step of the coding process. A code 
book will be developed to systematize data analysis and ensure findings are reproducible. Interrater reliability 
and trustworthiness will be evaluated as part of the qualitative analytic process.30 Two individuals with varied 

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backgrounds will independently review and code the transcripts. Discrepancies will be resolved through 
discussion until consensus is reached. 
 
Aim 2 
Feasibility will be assessed by examining accrual rates, attrition rates, adherence to the study protocol, 
hardware issues, software issues, and use of the intervention (e.g., frequency and duration of visits). Within 
study measures will be collected after every video visit to examine feasibility and acceptability of the intervention. 
Furthermore, an acceptability questionnaire will be administered at the end of the study to caregivers to obtain 
feedback on the intervention as a whole. 
Quantitative care outcomes being collected fall into three main categories: patient outcomes (e.g., symptom-
related measures), caregiver outcomes (e.g., burden, depression, anxiety, satisfaction, preparedness, 
competence, caregiver health), and healthcare utilization outcomes (e.g., number of visits, hospitalizations). 
Given the scope of this proposal, the number of caregiver participants (n=30) proposed for this study is aimed 
at establishing feasibility and acceptability and not efficacy. However, we will conduct preliminary efficacy 
analysis on outcomes at baseline and post intervention. Looking at pain (Doloplus-2 scale) as one of the 
secondary outcomes, with the assumption of a 40% improvement in scores based on a mean of 8.3 and SD of 
6.531, there will be 80% power to detect an effect size of d=0.5, which is considered a moderate effect. 
 
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