STAR Caregivers - Virtual Training and Follow-up
Phase: NA
Conditions: Alzheimer Disease, Dementia, Caregiver Burnout
Sponsor: Kaiser Permanente

STAR Caregivers – Virtual Training and Follow-up 
Version 4 
Grant Number: 1 R01AG061926-01 
13 August 2024 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
 
 
 
STAR Caregivers – Virtual Training and Follow-up 
 
Grant Number:  1 R01AG061926-01 
 
Principal Investigator:  Robert Penfold, PhD 
 
Version Number:  V4 
9 August 2024 
 

STAR Caregivers – Virtual Training and Follow-up 
Version 4 
Grant Number: 1 R01AG061926-01 
13 August 2024 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
 
 
SIGNATURE PAGE 
Signatures constituting approval of this protocol and the attachments and providing necessary 
assurances that this trial will be conducted according to all stipulations of the protocol, including all 
statements regarding confidentiality, and according to local legal and regulatory requirements and 
applicable U.S. federal regulations and guidelines. 
 
Signatories for this protocol are:  
 
 
_____________________________________ 
Robert Penfold, PhD – Principal Investigator 
Senior Investigator 
Kaiser Permanente Washington Health Research Institute 
 
 
 

STAR Caregivers – Virtual Training and Follow-up 
Version 4 
Grant Number: 1 R01AG061926-01 
13 August 2024 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
 
TABLE OF CONTENTS 
PAGE 
SIGNATURE PAGE ............................................................................................................................... 2 
TABLE OF CONTENTS .......................................................................................................................... 3 
LIST OF ABBREVIATIONS ..................................................................................................................... 6 
PROTOCOL SUMMARY – SUAY PRAGMATIC EFFECTIVENESS TRIAL ...................................................... 7 
1 
KEY ROLES AND CONTACT INFORMATION .................................................................................. 8 
2 
INTRODUCTION: BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE .............................. 9 
2.1 
Background Information ........................................................................................................ 9 
2.2 
Rationale and Objectives ....................................................................................................... 9 
3 
OUTCOME MEASURES ............................................................................................................. 11 
3.1 
Primary Outcomes ............................................................................................................... 11 
3.2 
Secondary Outcomes ........................................................................................................... 11 
4 
TRIAL DESIGN ......................................................................................................................... 13 
5 
STUDY ENROLLMENT AND WITHDRAWAL ................................................................................ 14 
5.1 
Inclusion and Exclusion Criteria for Persons Living with Dementia ..................................... 14 
5.2 
Inclusion and Exclusion Criteria for Caregiver Subjects ....................................................... 14 
5.3 
Randomization Assignment Procedures .............................................................................. 15 
5.3.1 
Randomization Procedures ..................................................................................... 15 
5.3.2 
Blinding ................................................................................................................... 15 
5.4 
Withdrawal ........................................................................................................................... 15 
5.5 
Control arm .......................................................................................................................... 15 
6 
INTERVENTION ARM ............................................................................................................... 16 
6.1 
Intervention Arm .................................................................................................................. 16 
6.2 
Eligibility Confirmation ......................................................................................................... 16 
6.3 
Consent ................................................................................................................................ 17 
6.3.1 
Verbal Consent for screening questions ................................................................. 17 
6.3.2 
Verbal Consent for participation in study ............................................................... 18 
6.3.3 
Caregiver is not the DPOA or Priority Person ......................................................... 18 
6.4 
Orientation Call .................................................................................................................... 19 
6.4.1 
Intervention Arm only ............................................................................................. 19 
6.5 
Online Learning Modules ..................................................................................................... 19 
6.6 
Weekly Coach Phone Calls ................................................................................................... 20 
6.7 
Secure Messaging (Email in the patient portal) ................................................................... 20 
6.8 
Procedures for Training Study Coaches and Fidelity Monitoring ........................................ 20 
7 
STATISTICAL CONSIDERATIONS................................................................................................ 21 

STAR Caregivers – Virtual Training and Follow-up 
Version 4 
Grant Number: 1 R01AG061926-01 
13 August 2024 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
 
7.1 
Sample Size Considerations ................................................................................................. 21 
7.1.1 
Statistical Power for Primary Outcome................................................................... 21 
7.2 
Analysis Plan ......................................................................................................................... 21 
7.2.1 
Statistical Analysis Plan ........................................................................................... 21 
7.2.2 
Aim 1. Feasibility/Acceptability ............................................................................... 21 
7.2.3 
Feasibility/Acceptability - Completion of Training. ................................................. 22 
7.2.4 
Assess the feasibility and acceptability from the payer perspective. ..................... 22 
7.2.5 
Primary Care, Urgent Care and Emergency Department Use. ................................ 22 
7.2.6 
Effect of STAR-VTF on CG burden and PLWD antipsychotic medication use.......... 22 
7.2.7 
Caregiver depression, stress and self-efficacy. ....................................................... 22 
7.3 
Handling of Missing Data ..................................................................................................... 23 
8 
PRAGMATIC TRIAL OVERSIGHT ................................................................................................ 24 
8.1 
Data Safety Monitoring by Safety Officer ............................................................................ 24 
9 
QUALITY CONTROL AND QUALITY ASSURANCE ........................................................................ 25 
9.1 
Study Procedures ................................................................................................................. 25 
9.2 
Protocol Deviations .............................................................................................................. 25 
10 
ETHICS/PROTECTION OF HUMAN SUBJECTS ............................................................................. 26 
10.1 
Ethical Standard ................................................................................................................... 26 
10.2 
Potential Risks and Benefits ................................................................................................. 26 
10.2.1 Potential Risks ......................................................................................................... 26 
10.2.2 Potential Benefits .................................................................................................... 26 
10.3 
Institutional Review Board ................................................................................................... 26 
10.4 
Subject Confidentiality ......................................................................................................... 26 
10.5 
Future Use of Identifiable Data ............................................................................................ 27 
11 
DATA HANDLING AND RECORD KEEPING ................................................................................. 28 
11.1 
Data Management Responsibilities ..................................................................................... 28 
11.2 
Data Capture Methods ......................................................................................................... 28 
11.3 
Study Records Retention ...................................................................................................... 28 
12 
DATA SHARING PLAN .............................................................................................................. 29 
12.1 
Data Sharing Experience ...................................................................................................... 29 
12.2 
Data and Resource Sharing Plan .......................................................................................... 29 
12.2.1 Access - STAR-VTF Repository and Data Sharing Capacity ...................................... 29 
12.2.2 Timetable for Data Release ..................................................................................... 30 
12.2.3 Restrictions to Data Sharing .................................................................................... 30 
12.2.4 Data Deidentification Procedures ........................................................................... 30 
12.2.5 Data Curation and Documentation ......................................................................... 31 
12.3 
Data Sharing Summary ......................................................................................................... 31 
13 
REFERENCES ........................................................................................................................... 32 

STAR Caregivers – Virtual Training and Follow-up 
Version 4 
Grant Number: 1 R01AG061926-01 
13 August 2024 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
 
 

STAR Caregivers – Virtual Training and Follow-up 
Version 4 
Grant Number: 1 R01AG061926-01 
13 August 2024 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
 
LIST OF ABBREVIATIONS 
ABCs 
Antecedent, Behavior, Consequence 
ADRD 
Alzheimer’s Disease and Related Dementias 
BPSD 
Behavioral and Psychological Symptoms of Dementia 
CG 
Caregiver 
CMS 
Caregiver Master Scale 
DPOA 
Durable Power of Attorney 
DSRS 
Dementia Severity Rating Scale 
EHR 
Electronic Health Record 
FAQ 
Functional Activities Questionnaire 
GAD 
7 item General Anxiety Disorder scale 
GEE 
Generalized Estimating Equations 
HIPAA 
Health Insurance Portability and Accountability Act 
HITECH 
Health Information Technology for Economic and Clinical Health Act 
ICD-10 
International Classification of Diseases, 10th Revision 
IRB 
Institutional Review Board 
KPWA 
Kaiser Permanente Washington 
KPWHRI 
Kaiser Permanente Washington Health Research Institute 
LAR 
Legally Authorized Representative 
MHRN 
Mental Health Research Network 
NACDA 
National Archive of Computerized Data on Aging 
NIA 
National Institute on Aging 
PHQ8 
8-item Patient Health Questionnaire 
PLWD 
Person Living With Dementia 
REDCap 
Research Electronic Data Capture [software] 
RMPBC 
Revised Memory and Problem Behavior Checklist 
SFT 
Secure File Transfer 
STAR-VTF 
Staff Training in Assisted living Residences – Virtual Training and 
Follow-up 
 
 
 

STAR Caregivers – Virtual Training and Follow-up 
Version 4 
Grant Number: 1 R01AG061926-01 
13 August 2024 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
 
PROTOCOL SUMMARY – SUAY PRAGMATIC EFFECTIVENESS TRIAL 
Title: 
STAR Caregivers – Virtual Training and Follow-up 
Précis: 
The STAR-Caregivers program is an education, training, and support 
intervention demonstrated efficacious in reducing the behavioral and 
psychological symptoms of dementia. The investigators propose to test a 6-
session, self-directed, online version called STAR-virtual training and follow-up 
(STAR-VTF) that leverages secure email within the member portal at Kaiser 
Permanente Washington, an online learning management system, and 6 30-
minute coaching telephone calls to improve access to training, fidelity to the 
STAR principles, and to lower the cost of the program. Outcomes in the 
intervention arm will be compared to an attention control group that receives 
printed materials and links to online training resources but does not receive 
coaching. 
Objectives: 
Test the effectiveness of the intervention training vs. attention control in a 
practical clinical trial involving one hundred caregiver-person living with 
dementia dyads at Kaiser Permanente Washington. 
Populations: 
 Persons living with dementia and their informal caregivers (spouses and adult 
children) 
Site: 
Kaiser Permanente Washington 
Description of 
Intervention: 
This study evaluates the effectiveness of a caregiver outreach, self-directed 
online training, and support program for caregivers of people with dementia 
who are using an antipsychotic medication to manage agitation/aggression. 
The Investigators will conduct a randomized trial of the caregiver program 
compared to a control group to measure differences in caregiver burden and 
discontinuation of antipsychotic medication use. The results will help in 
expanding access to and delivery of empirically supported behavioral health 
services for caregivers and persons living with dementia. 
Trial Duration: 
18 months 
Subject 
Participation 
Duration: 
6 months 
Estimated Time to 
Complete 
Enrollment: 
12 months 
 
 

STAR Caregivers – Virtual Training and Follow-up 
Version 4 
Grant Number: 1 R01AG061926-01 
13 August 2024 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
 
1 
KEY ROLES AND CONTACT INFORMATION 
Principal Investigator:   
Robert Penfold, PhD, Scientific Investigator III 
Kaiser Permanente Washington Health Research Institute (KPWHRI) 
1730 Minor Avenue, Suite 1600 
Seattle, WA 98101 
Robert.B.Penfold@kp.org 
(206) 287-2232 
Program Director:   
Lisa Onken, NIA 
Institutions: 
Kaiser Permanente Washington  
University of Washington 
Co-Investigators: 
Linda Teri, PhD, University of Washington 
Susan McCurry, PhD, University of Washington 
 

STAR Caregivers – Virtual Training and Follow-up 
Version 4 
Grant Number: 1 R01AG061926-01 
13 August 2024 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
 
2 
INTRODUCTION: BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE  
2.1 
Background Information 
Alzheimer’s Disease and related dementias (ADRD) are debilitating conditions affecting more than 5 
million Americans in 2014.(1, 2) With aging of the population it is projected that 8.4 million people will 
be diagnosed with ADRD over the next 15 years(3, 4) and health care costs attributable to ADRD are 
projected to be more than 1.2 trillion by 2050.(2) Behavioral and Psychological Symptoms of Dementia 
(BPSD) (anxiety, agitation, depression) are common and often involve aggressive behavior towards 
family caregivers (CG) in response to unmet needs, discomfort, or frustration. BPSD are disturbing and 
frequently lead to CG seeking medication to control patient symptoms. Antipsychotic use in persons 
living with dementia (PLWD) more than doubles mortality risk;(5) however, many caregivers are willing 
to accept those risks. The Choosing Wisely Guidelines from the American Psychiatric Association(6) and 
American Geriatrics Society(7) both recommend against prescribing antipsychotics as a first-line 
treatment for BPSD. STAR-Caregivers is an efficacious first-line behavioral treatment, endorsed by the 
Administration on Aging,(8) that involves caregiver training to manage BPSD.(9-16) However, the 
program has not been implemented widely – partly due to the cost of the programs,(17) difficulty 
conducting outreach,(18, 19) and modality of training (in person with written materials). Adequate 
caregiver training and commensurate reduction in caregiver burden are the mediators (mechanisms) we 
will engage in this Stage III trial to reduce BPSD and discontinue antipsychotic medication use by PLWD.  
 
2.2 
Rationale and Objectives 
The STAR-Caregivers program is an education, training, and support intervention demonstrated 
efficacious in reducing BPSD.(9, 10, 20, 21) The original program involved 8 face-to-face, in-home 
training sessions and 4 follow-up phone calls. The condensed version involves 4 in-home sessions with 2 
phone follow-ups.(18) Neither of these is feasible from a payer perspective due to the cost and, more 
recently, the COVID-19 pandemic makes home visits risky. We will test a self-directed, online version 
called STAR-virtual training and follow-up (STAR-VTF) that leverages weekly telephone calls and secure 
email within the member portal at Kaiser Permanente Washington to improve access to training, fidelity 
to the STAR principles, and to lower the cost of the program. 
 
This trial will ascertain the feasibility and acceptability of STAR-VTF in which (a) caregiver training 
materials are delivered electronically and learning is self-directed, (b) caregivers have 7 telephone calls 
with a social worker and (c) where caregivers receive ongoing support from a social worker via secure 
messaging in the web-based portal (My Kaiser Permanente). We will compare outcomes in the STAR-VTF 
group to an attention control group that receives mailed material from the Alzheimer’s Association and 
National Institute of Mental Health plus generic secure messages. Our specific aims are: 
AIM 1: Assess the feasibility and acceptability of conducting caregiver outreach, training, and support via 
social workers and licensed mental health counselors including: (1) willingness of caregivers to interact 
through secure messaging (contact rates) and telephone; and (2) willingness of caregivers to complete 
self-directed training (training completion rates). 

STAR Caregivers – Virtual Training and Follow-up 
Version 4 
Grant Number: 1 R01AG061926-01 
13 August 2024 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
 
AIM2: Assess the feasibility and acceptability of the program from the payer perspective including: (1) 
average time spent per orientation visit; (2) average time per month spent responding to caregiver 
emails and coordinating care with primary care physicians; and (3 differences in face-to-face primary 
care, urgent care, and emergency department visit rates by PLWD. 
AIM 3: Test the hypotheses that (H1) caregiver participants in STAR-VTF will have lower levels of 
caregiver burden at 8 weeks and 6 months compared to an attention control group; and (H2) PLWD 
participants in STAR-VTF will have lower rates of antipsychotic medication use at 6 months compared to 
control. Secondary outcomes are: caregiver depression, caregiver stress and caregiver self-efficacy. We 
propose to recruit 100 CG-PLWD dyads (50 per arm).  
This will be the first study to test a low intensity, self-directed caregiver training program with remote 
support from social workers. It will also be the first study to measure changes in antipsychotic 
medication use by PLWD after CG training. Kaiser Permanente is an ideal setting because we have access 
to the complete EHR, prescription medication use, health care use, and demographic data. We will be 
able to identify and enroll participants in real-time using an automated data algorithm as we have done 
previously.(22) This study will be an important step in expanding access to training and support in a 
format that could be implemented within integrated delivery systems with capitated payments (i.e., 
Accountable Care Organizations). Growing use of EHR portals in these organizations will further increase 
demand for web-based care management/support. Demand will also increase as today’s near-retirees, 
familiar with web-based applications, develop ADRD. Kaiser Permanente has pioneered such efforts and 
is the lead site in the Mental Health Research Network (MHRN). Findings from this study will inform a 
future multi-site pragmatic trial across the 13 health systems and 12 million enrollees in the MHRN. 
 

STAR Caregivers – Virtual Training and Follow-up 
Version 4 
Grant Number: 1 R01AG061926-01 
13 August 2024 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
 
3 
OUTCOME MEASURES 
Outcome measures will be collected regardless of the extent to which intervention arm caregivers or 
families accepted or utilized interventional components. That is, we will follow an intent-to-treat 
approach and encouragement trial methods. 
3.1 
Primary Outcomes 
The following primary quantitative outcome measures for the trial will be assessed for the grant 
deliverables: 
(1) Change in caregiver burden at 8 weeks and 6 months. Self-reported caregiver burden will be 
assessed by the Disruption subscale on the Revised Memory and Behavior Problem Checklist 
(RMBPC) questionnaire.  The range in subscale scores is 0 to 32 with higher scores representing a 
worse outcome. 
3.2 
Secondary Outcomes 
The following secondary outcome measures for the trial will be assessed: 
(1) Antipsychotic medication Use. Proportion of participants will at least one antipsychotic prescription 
refill after initial medication dispensing, using automated system pharmacy data. 
(2) Change in caregiver depression. Self-reported caregiver depression assessed by the 8-item Patient 
Health Questionnaire (PHQ-8). The PHQ-8 is an eight-item measure of depression that assesses 
symptoms over the last two weeks. The total sum of the 8 responses from the PHQ-8 ranges 
between 0 and 24 with higher scores indicating worse outcome. In general, a total of 10 or above is 
suggestive of the presence of depression. 
(3) Change in caregiver self-efficacy. Self-reported caregiver self-efficacy assessed by the Caregiver 
Mastery Scale. Total scores can range from 7 to 35, with higher scores reflecting greater caregiver 
mastery. The Caregiver Mastery Scale is a 7-item measure of self-efficacy. is a 7-item self-report 
scale, indicating the extent to which respondents agree (5) or disagree (1) with each item. Three 
items with negative statements are reverse-scored. Total scores can range from 7 to 35, with higher 
scores reflecting greater caregiver mastery. 
(4) Change in caregiver stress. Caregiver stress will be measured on the Kingston Caregiver Stress Scale. 
This is a 10-item measure with respondents rating the level of stress between 1 (coping fine, no 
stress) to 5 (extreme stress, feeling at the end of rope). Total scores vary between 10 and 50.  
(5) Response rates for baseline, 8-week, and 6-month measures. We will assess participants’ 
willingness to complete study measures using the REDCap online survey by the proportion 
completing study measures at each time point. 
(6) Training Completion rate. We will report training completion rates as a measure of feasibility. 
Completion will be defined as viewing all 6 online training modules, conducting at least 3 phone calls 
with a study coach and sending at least one secure message to a study coach in the baseline to 8-
week period and one message in weeks 9 through 24. 
(7) Primary care visit rates. Measured as the number of primary care visits per eligible study participant 
during the study period. 

STAR Caregivers – Virtual Training and Follow-up 
Version 4 
Grant Number: 1 R01AG061926-01 
13 August 2024 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
 
(8) Urgent care visit rates. Measured as the number of urgent care visits per eligible study participant 
during the study period. 
(9) Emergency department visit rates. Measured as the number of emergency department care visits 
per eligible study participant during the study period. 
(10) Case management time. We will estimate the time spent responding to ad hoc secure messages and 
phone calls by caregivers in order to inform the feasibility of the intervention from a payer 
perspective. 

STAR Caregivers – Virtual Training and Follow-up 
Version 4 
Grant Number: 1 R01AG061926-01 
13 August 2024 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
 
4 
TRIAL DESIGN 
We will conduct a parallel, two-arm pragmatic clinical trial comparing the intervention and attention 
control groups. The follow up period for the trial will be 6 months.  

STAR Caregivers – Virtual Training and Follow-up 
Version 4 
Grant Number: 1 R01AG061926-01 
13 August 2024 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
 
5 
STUDY ENROLLMENT AND WITHDRAWAL 
5.1 
Inclusion and Exclusion Criteria for Persons Living with Dementia 
The investigators will identify and recruit PLWD-CG dyads in which the PLWD has filled a new 
prescription for an antipsychotic medication. The study programmer will identify potential PLWD-CG 
dyads using an automated data algorithm that queries claims data and electronic health record (EHR) 
data on a weekly basis. 
Because we will enroll dyads, there are inclusion/exclusion criteria for both persons living with dementia 
and their caregivers. 
Persons with dementia inclusion criteria: 
• 
Aged ≥ 65 years 
• 
Diagnosis of Alzheimer's Disease or related dementia (ADRD) 
• 
Expected to live >= 6 months from enrollment 
Persons with dementia exclusion criteria: 
• 
A diagnosis of bipolar disorder or schizophreniform disorder 
• 
The primary care physician's opinion is that the person with dementia is expected to live less 
than 6 months. 
• 
Primary language is not English (patient requires a translator). 
5.2 
Inclusion and Exclusion Criteria for Caregiver Subjects 
Potentially eligible caregivers are identified by the family contact information in the electronic medical 
record.  
Caregiver inclusion criteria: 
• 
Aged ≥ 21 years 
• 
Lives with person with dementia or within 8 miles 
• 
Provides at least 8 hours of care per week 
Caregiver exclusion criteria: 
• 
Diagnosis of Alzheimer's Disease or related disorders. 
• 
Caregiver is not the spouse or adult child of the person living with dementia 
• 
Primary language is not English (caregiver requires a translator). 

STAR Caregivers – Virtual Training and Follow-up 
Version 4 
Grant Number: 1 R01AG061926-01 
13 August 2024 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
 
5.3 
Randomization Assignment Procedures 
5.3.1 
Randomization Procedures  
The study biostatistician will create a randomization schedule and this will be uploaded into a REDCap 
database. Caregivers who remain eligible for the study after screening will be randomized within 
REDCap following the pre-set randomization schedule. All eligible caregiver-patient dyads will be block 
randomized to ensure comparable numbers of dyads enrolled in each study arm. Caregivers will be 
categorized according to age (<75 years, >=75 years), sex, and spouse/non-spouse. 
R, an open-source statistical computing software, will be used to generate an even number of control 
and intervention assignments within each block. 
5.3.2 
Blinding 
Study staff will be blinded to study arm when verifying subject eligibility.  
STAR Caregiver coaches interact with both intervention and control arm subjects. Group assignment is 
therefore known to these study staff. For the control group, coaches will conduct the consent process 
and orient participants to the printed and online materials available from the Alzheimer’s Association.  
The PI will remain blinded to arm assignment until follow-up is complete. Only the study biostatistician, 
programmer, and project manager will be un-blinded to arm when preparing reports for the Safety 
Officer. The PI will be un-blinded for reporting any serious adverse events or incidental deaths to the 
Safety Officer and NIA staff, should such events occur during the course of the trial.  
5.4 
Withdrawal 
Caregivers are free to withdraw from study activities at any time. However, we will still measure 
antipsychotic medication utilization rates between intervention and control. A waiver of consent to 
access PLWD medical records after withdrawal will be obtained. 
5.5 
Control arm 
We will use an attention control arm. PLWD-Caregiver dyads randomized to the control arm will receive 
paper-based information from the Alzheimer’s Association and National Institute on Aging including 
links to online training resources. Control arm participants will also receive 3 scripted secure messages 
(one at 4 weeks, one at 8 weeks and one at 6 months following randomization) to remind them to read 
the provided materials, check the provided web links to training resources, and check in with their 
primary care physician if they have concerns about the PLWD. 
 
.  
 

STAR Caregivers – Virtual Training and Follow-up 
Version 4 
Grant Number: 1 R01AG061926-01 
13 August 2024 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
 
6 
INTERVENTION ARM 
6.1 
Intervention Arm  
Randomized PLWD-CG dyads are offered:  
• 
A telephone orientation visit with a study coach to acquaint the caregiver to the 6-
session STAR-VTF program and online learning environment. 
• 
A paper-based and electronic manual to identify priority behaviors, develop plans for 
addressing behaviors, and make plans for pleasant events. 
• 
6 weekly telephone coaching visits lasting 30 minutes and corresponding to each of the 
6 training modules. 
• 
Secure message (email) support within the patient portal, as needed, with the coach to 
help with personalizing the STAR-VTF curriculum for up to 6 months, as initiated by the 
caregiver. 
We anticipate that self-directed caregiver training with support from social workers will enhance 
caregivers’ sense of competence and self-efficacy. Training caregivers on good communication and the 
ABCs of dementia problem-solving will lead to decreased activation of behavioral triggers, lower 
incidence of problem behaviors, and lower caregiver stress in response to behaviors. Assisting caregivers 
to engage in higher levels of pleasant activities will enhance PLWD and caregiver mood and create a 
more positive care environment.  With increased insight into the natural disease history, caregivers will 
be able to reframe behaviors as symptoms of dementia rather than insensitivity, rudeness, or deliberate 
provocation. We hypothesize that changes in the physical and psychosocial environment that reduce 
triggering events and improve caregiver-PLWD dyadic interactions will reduce the need for and use of 
antipsychotic medication. 
 
6.2 
Eligibility Confirmation 
Once a PLWD is identified using the automated algorithm, a REDCap database is populated with the 
potential participants once per week. There are three steps to confirming eligibility. 
• 
A study staff person will review the PLWD medical record to confirm that the person has a 
diagnosis of ADRD, an emergency contact or other family/friend is listed in the record, and that 
the PLWD does not live in an adult family home, skilled nursing facility, or memory facility. 
• 
If eligible after medical record review, the staff person will contact a study coach (clinician) who 
will send a staff message within the EHR to the physician who prescribed the antipsychotic 
medication to the PLWD. The prescribing clinician will be asked: 
o Is [PLWD] capable of making health care decisions for themselves? 
[YES/NO/SOMETIMES] 
o Do you believe [PLWD] will live at least 6 months from today? [YES/NO] 

STAR Caregivers – Virtual Training and Follow-up 
Version 4 
Grant Number: 1 R01AG061926-01 
13 August 2024 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
 
o Was [antipsychotic medication] prescribed for behavioral/psychological symptoms of 
dementia? [YES/NO] 
o Is there any other reason to NOT invite this patient and family caregiver to be in the 
research study? [YES/NO] 
Recruitment will not proceed without a response to these questions by the prescribing clinician. 
In the third stage, a study staff person will mail an invitation letter to the PLWD-CG dyad. This is 
followed by a screening phone call approximately 3 business days later. The purpose of the screening 
call is to determine: 
• 
Willingness to take part in the study regardless of the randomization group. 
• 
Ability to read and speak English. 
• 
Determine whether the CG has ever been diagnosed with Alzheimer’s disease or related 
dementia 
• 
Confirm the PLWD does not live in an adult family home, assisted living facility, skilled nursing 
facility, or memory facility. 
• 
Whether the caregiver is 21 years or older. 
• 
Whether the caregiver lives in the same household as the PLWD or within 8 miles (30 minutes). 
• 
Whether the caregiver spends at least 8 hours providing care to the PLWD 
• 
Whether the caregiver is the DPOA and if not who that person is. 
• 
Whether the caregiver is the spouse or adult child of the PLWD 
• 
Caregiver access to a computer or other device where the caregiver can access the patient 
portal, personal email and websites to complete the online training. 
• 
Whether the caregiver uses MyChart – the Kaiser Permanente patient portal - to email the 
doctors that care for the PLWD 
• 
Administer the Short Portable Mental Status Questionnaire to the caregiver. 
 
If the PLWD-CG dyad remains eligible after the 3-step verification process then a study staff person will 
randomize the dyad in REDCap and schedule an orientation telephone visit. 
If the caregiver is not the DPOA and the PLWD is unable to consent, the study staff person will request 
the contact information of the person who is DPOA. If the dyad is otherwise eligible, the DPOA will be 
contacted to obtain verbal consent on behalf of the PLWD. 
6.3 
Consent 
6.3.1 
Verbal Consent for screening questions 
Following the recruitment packet mailing, two things may happen: 
1. 
 Potential participants may call our study line and express interest in participating or decline to 
participate. Those expressing an interest will receive a phone call from a Research Specialist and those 
who decline to participate will be coded as such and not contacted. 
2. 
If we have not heard from the potential caregiver participant, we will follow-up with a phone 
call to assess interest and eligibility. 

STAR Caregivers – Virtual Training and Follow-up 
Version 4 
Grant Number: 1 R01AG061926-01 
13 August 2024 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
 
During the screening phone call, the Research Specialist will describe the study, answer any questions, 
and administer a phone screening questionnaire to assess eligibility after verbal consent is given. 
6.3.2 
Verbal Consent for participation in study 
If the PLWD-CG dyad is eligible after the phone screening questionnaire, an orientation phone visit will 
be scheduled. A study coach will obtain verbal informed consent from the caregiver on the day of their 
orientation phone visit prior to any study activities. The coach will read the consent forms to the 
caregiver and PLWD, emphasizing that study participation is voluntary and that if the caregiver or PLWD 
decides not to participate, the decision will have no impact on the care of the PLWD. The coach will also 
explain that the caregiver or PLWD can stop the consent process or the study at any point if they decide 
they no longer want to participate. The caregiver and PLWD will have an opportunity to ask questions 
prior to giving verbal consent. The caregiver and PLWD will have a copy of the consent forms mailed to 
them with the invite letter and will instructed to have these in front of them during the call.  
6.3.3 
Caregiver is not the DPOA or Priority Person 
If the caregiver is not the DPOA or priority person, and either the doctor or the caregiver have indicated 
that they believe the PLWD is unable to consent for themselves, we will contact the DPOA or priority 
person to obtain verbal consent for the PLWD to participate in the study prior to scheduling the 
orientation phone visit. A study staff member will contact the DPOA/LAR, describe the study in detail, 
and answer any questions. The study staff member will get verbal consent from the DPOA or legally 
authorized representative (LAR) for the PLWD to participate. The study staff member will mail a copy of 
the consent form to the DPOA/LAR following the phone call. If the DPOA/LAR gives verbal consent for 
the PLWD to participate, study staff will then call the caregiver to schedule the orientation phone visit. 
The purpose of this is to avoid scheduling a phone visit and randomizing a dyad should the DPOA not 
give consent for the PLWD to participate. 
The consent process will vary depending on the following factors: 
(1) The PLWD is able to consent for themselves. The PLWD’s provider will inform the study coach as 
to his/her medical opinion to the PLWD’s incompetence (the provider’s response to this 
question is required in order for the PLWD and caregiver to participate).  
(2) The PLWD is not able to consent for themselves and the caregiver IS either the DPOA or the 
priority person authorized to make decisions on the PLWDs behalf. 
(3) The PLWD is not able to consent for themselves and the caregiver is not the DPOA or the 
priority person authorized to make decisions on the PLWDs behalf. 
Under Case #1, the PLWD gives consent on their own behalf. Under case #2, the caregiver gives verbal 
consent on behalf of the PLWD. If possible, we will get verbal assent from the PLWD as well. Under case 
#3, prior to the visit study staff will speak with the DPOA or the priority person authorized to make 
decisions on behalf of the PLWD and get verbal consent for the PLWD to participate in the study. A copy 
of the consent form will be mailed to the DPOA or priority person for their records. 

STAR Caregivers – Virtual Training and Follow-up 
Version 4 
Grant Number: 1 R01AG061926-01 
13 August 2024 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
 
6.4 
Orientation Call 
The purpose of the orientation telephone call is to: 
• 
Make introductions 
• 
Review consent forms and obtain informed consent 
• 
Orient the caregiver to the baseline measures survey site (online) and confirm their ability to 
login and complete the baseline measure survey 
• 
Confirm the caregiver has received the printed materials corresponding to their study arm 
6.4.1 
Intervention Arm only 
Participants randomized to the intervention arm will also be oriented to the online learning modules. A 
study coach will give caregivers an overview of the program and assist the caregiver to: 
• 
Navigate to the Kaiser Permanente School learning modules site 
• 
Login using their credentials 
• 
Give an overview of the learning modules, the cadence of completion (one per week), and 
required homework 
• 
Schedule the first 30-minute check-in regarding Session One of the program. 
6.5 
Online Learning Modules 
There are 6 self-directed learning modules for intervention arm participants to complete. Modules 
consist of text, figures and audio describing the principles of the STAR Caregivers program. The modules 
are: 
(1) Introduction to STAR-Caregivers, Overview of Dementia, Principles of Communication 
(2) ABCs of Problem Solving 
(3) Review of ABCs and Modifying Plans 
(4) Pleasant Events 
(5) Review of Pleasant Events, ABCs, Practical Communication 
(6) Pleasant Events for Caregivers 
Each module takes between 30 and 45 minutes to complete and participants are expected to complete 
one module per week. Participants complete the homework and reading assignments following 
completion of each module. Study coaches review problem solving plans, pleasant events schedules and 
any questions about the material or individual needs during follow-up phone calls. 

STAR Caregivers – Virtual Training and Follow-up 
Version 4 
Grant Number: 1 R01AG061926-01 
13 August 2024 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
 
6.6 
Weekly Coach Phone Calls 
Caregivers are invited to participate in weekly, 30-minute phone calls with a study coach to review 
material from the relevant training session. Coaches will provide ad hoc advice on the nature and 
disease process of ADRD, realistic expectations for PLWD behavior, practical communication, how to 
complete/revise ABC problem solving plans, how to complete/revise the pleasant events schedule, and 
how to obtain formal and informal respite from caregiving. 
6.7 
Secure Messaging (Email in the patient portal) 
Caregivers will be invited to communicate with their coach via email at the completion of the 6-week 
training program and up to the end of the 6-month follow-up period. Coaches will only respond to 
messages initiated by caregivers. Telephone support will be given only as necessary. 
6.8 
Procedures for Training Study Coaches and Fidelity Monitoring 
Drs. McCurry and Teri are clinical psychologists and the original developers of the STAR Caregivers 
training program. They will train study coaches on the STAR Caregivers curriculum and consultation best 
practices.  
Drs. McCurry and Teri will meet by regular conference call with study coaches to discuss fidelity to the 
STAR Caregivers program by anonymously discussing case examples.  
The study coaches will keep weekly progress notes that include a checklist confirming what content 
areas are covered from the protocol during the telephone sessions, information about the types of ABC 
and pleasant event plans developed by caregivers, and the frequency and content of secure messages 
initiated. Therapist quality control will be assured through a sample of in-person observed sessions 
overseen by Drs. Teri and McCurry.    

STAR Caregivers – Virtual Training and Follow-up 
Version 4 
Grant Number: 1 R01AG061926-01 
13 August 2024 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
 
7 
STATISTICAL CONSIDERATIONS 
7.1 
Sample Size Considerations 
We anticipate enrolling 100 PLWD-CG dyads in the trial (50 per arm), with up to 90 remaining enrolled at 
6 months of follow-up (i.e., 10% lost to follow-up).  
7.1.1 
Statistical Power for Primary Outcome.   
We calculated effect sizes for the impact of STAR-C on the Subjective Caregiver Burden scale (d=0.77) 
and the Revised Memory and Behavior Problem Checklist (d=0.68) based on the p-values reported for t-
tests comparing the STAR-C mean with the routine medical care group mean in prior research. We will 
power on the RMBPC (primary outcome) and assume a loss of effect size due to the lower intensity of 
the intervention. Assuming an effect size of 0.65, type-I error of 0.05, power of 80%, and equal sample 
sizes, we will require 39 dyads in the STAR-VTF arm and 39 dyads in the control arm (n=78). We 
additionally assume it will be necessary to adjust for baseline covariate imbalance and sample attrition, 
thus, we will inflate our recruitment targets by 30% as we have done in the past. The final recruitment 
target will be 50 PLWD-CG dyads in each arm. 
 
7.2 
Analysis Plan 
Data will be collected from project tracking systems, the Epic EMR, and other health system data 
systems for analysis. Baseline, 8 week, and 6 month measures will be collected via an online survey 
using REDCap functionality. 
Data validation and quality assurance checks will be undertaken to ensure data collection during the 
study is sufficiently reliable.  
7.2.1 
Statistical Analysis Plan 
All analyses will be conducted under intention-to-treat principles. 
 
7.2.2 
Aim 1. Feasibility/Acceptability 
We will measure response rates for follow-up data collection using the online survey functionality in 
REDCap. We will use descriptive statistics to characterize response rates by study arm and demographic 
characteristics.  We will use generalized estimating equations (GEE) with a working correlation matrix to 
estimate a logistic regression model for response vs. non-response. We will estimate separate models 
for the 8-week and 24-week outcome periods. Models will be adjusted for PLWD stage of dementia 
(DSRS), PLWD FAQ score, PLWD age and sex, caregiver relationship (spouse, non-spouse), caregiver age 
and sex, caregiver highest level of education attained, PLWD residential status (living with caregiver full-
time versus not) and study arm.  
 

STAR Caregivers – Virtual Training and Follow-up 
Version 4 
Grant Number: 1 R01AG061926-01 
13 August 2024 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
 
7.2.3 
Feasibility/Acceptability - Completion of Training.  
We will use descriptive statistics to characterize completion rates by study arm and demographic 
characteristics. We will use generalized estimating equations (GEE) with a working correlation matrix to 
estimate a logistic regression model for completion vs. non-completion. Models will be adjusted for 
PLWD stage of dementia (DSRS), PLWD FAQ score, PLWD age and sex, caregiver relationship (spouse, 
non-spouse), caregiver age and sex, and caregiver highest level of education attained, and study arm.  
 
7.2.4 
Assess the feasibility and acceptability from the payer perspective. 
We will use descriptive statistics to characterize the effort required by coaches to facilitate caregiver 
training. These measures are (1) time reading secure messages, (2) number of exchanges per message 
thread, (3) number of ad hoc phone calls required (i.e., other than the 6 scheduled calls). 
 
7.2.5 
Primary Care, Urgent Care and Emergency Department Use.  
We will use longitudinal, generalized estimating equations (GEE) to estimate a Poisson regression model 
for adjusted mean monthly visit rates (separately by visit type) in the STAR-VTF arm compared to the 
attention control arm in the  6 months following randomization. Models will be adjusted for PLWD stage 
of dementia (DSRS), PLWD FAQ score, PLWD age and sex, caregiver relationship (spouse, non-spouse), 
caregiver age and sex, and caregiver highest level of education attained, and study arm. We will use the 
robust sandwich estimator to calculate standard errors to account for repeated (i.e. 6 monthly) 
observations within people and the misspecified variance in the Poisson model. 
  
7.2.6 
Effect of STAR-VTF on CG burden and PLWD antipsychotic medication use. 
We will measure overall caregiver burden using the Revised Memory and Problem Behavior Checklist 
(RMPBC). We will use GEE with a working correlation matrix to estimate the regression model, using 
robust sandwich estimators to calculate standard errors accounting for within person correlation. We 
will adjust for baseline pre-randomization covariates: PLWD stage of dementia (DSRS), PLWD FAQ score, 
PLWD age and sex, caregiver relationship (spouse, non-spouse), caregiver age and sex, and caregiver 
highest level of education attained. 
We will use generalized estimating equations (GEE) with a working correlation matrix to estimate a 
logistic regression model for refill (versus no refill) of the initial antipsychotic medication. Models will be 
adjusted for PLWD stage of dementia (DSRS), PLWD FAQ score, PLWD age and sex, caregiver relationship 
(spouse, non-spouse), caregiver age and sex, and caregiver highest level of education attained, study 
arm. We will again use GEE with a working correlation matrix to estimate a logistic regression model for 
daily versus “less than daily” use of antipsychotic medication (as reported to the coach). Models will 
again be adjusted for pre-randomization variables listed above. 
7.2.7 
Caregiver depression, stress and self-efficacy.  
 

STAR Caregivers – Virtual Training and Follow-up 
Version 4 
Grant Number: 1 R01AG061926-01 
13 August 2024 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
 
Caregiver depression will be measured using the PHQ-8. Caregiver self-efficacy will be measured using 
the Caregiver Mastery Scale. Caregiver stress will be measured using the Kingston Caregiver Stress Scale. 
We will again use GEE to compare the mean PHQ-8, CMS and Kingston scores in the STAR-VTF and 
attention control arms. Models will be adjusted for pre-randomization variables as above. 
 
7.3 
Handling of Missing Data 
Preventing missing data is superior to statistical treatment. We will make every effort to collect data on 
all study participants. If there are substantial missing data or significant loss-to-follow-up, we will use 
inverse probability weighting(23) to rebalance the STAR-VTF and attention control group. Inverse 
probability weights are used to rebalance groups on prognostic factors when the treatment and control 
groups become unbalanced over time, post-randomization, due to study drop out. If we find 
intermittent missing data, we will instead use multiple imputation(24) via chained equations to address 
the problem, using at least 10 imputed datasets and combining results using Rubin’s rules. 

STAR Caregivers – Virtual Training and Follow-up 
Version 4 
Grant Number: 1 R01AG061926-01 
13 August 2024 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
 
8 
PRAGMATIC TRIAL OVERSIGHT 
8.1 
Data Safety Monitoring by Safety Officer 
Dr. Elizabeth Phelan will act as the Safety Officer for the Phase 3 pragmatic trial.  
The Safety Officer and PI will advise NIA of its findings and reports will be shared with the KPWHRI IRB, 
as required. We will be responsive to additional specific requests for data reports that may be requested 
by the Safety Officer or NIA program staff.   
Confidentiality will be maintained during all phases of review and deliberations.   
A separate data safety monitoring plan accompanies this protocol.  
  

STAR Caregivers – Virtual Training and Follow-up 
Version 4 
Grant Number: 1 R01AG061926-01 
13 August 2024 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
 
9 
QUALITY CONTROL AND QUALITY ASSURANCE 
9.1 
Study Procedures 
Standard operating procedures for the study will be detailed in the Manual of Procedures. An overview 
of procedures is provided in this protocol.   
9.2 
Protocol Deviations 
Staff will immediately report protocol deviations to the Project Manager, who will inform the PI.  Any 
deviations will be considered noncompliance with this protocol or Good Clinical Practice.  Protocol 
deviations will include privacy breaches, and IT-related problems that lead to errors in protocol 
adherence.  
Protocol deviations that may impact patient safety or study data integrity will be immediately reported 
to the PI and PM. The Safety Officer will be informed within 5 business days of study staff becoming 
aware of a protocol deviation impacting patient safety or study data integrity. 
Staff will report all other protocol deviations. The KPWHRI IRB will be notified of deviations per reporting 
requirements. The NIA program director and Safety Officer will review protocol deviations in the regular 
data reports. 
Events not considered protocol deviations: Due to the pragmatic aspects of the study, the failure of a 
provider or patient to adhere to the protocol (e.g., not responding to request for information on a 
patient, not completing training), are not considered protocol deviations. These uncontrolled and 
expected events are of scientific interest due to the pragmatic nature of the study.  
 

STAR Caregivers – Virtual Training and Follow-up 
Version 4 
Grant Number: 1 R01AG061926-01 
13 August 2024 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
 
10 ETHICS/PROTECTION OF HUMAN SUBJECTS 
10.1 
Ethical Standard 
The investigator will ensure that this research study is conducted in full conformity with the principles 
set forth in The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects 
of Research, as drafted by the US National Commission for the Protection of Human Subjects of 
Biomedical and Behavioral Research (April 18, 1979) and codified in 45 CFR Part 46 and/or the ICH E6.  
10.2 
Potential Risks and Benefits 
None of the individual interventional components of this study are experimental in nature. All 
components have been tested and demonstrated effective elsewhere. No medications or other 
treatments are withheld or delayed. Prescribers are not advised to stop antipsychotic medications and 
remain free to exercise their own clinical judgment.  
10.2.1 
Potential Risks 
One component of the skills training is to brainstorm strategies for reducing problem behaviors. For 
example, PLWD may become oppositional/defiant when asked to get dressed or bathe. This 
brainstorming process involves some trial-and-error and it is possible that caregivers, with the best of 
intentions, may make problem behaviors temporarily worse as they experiment with their personalized 
strategies (A-B-C problem solving plan). This experience may be distressing and/or frustrating for both 
caregiver and PLWD.  
10.2.2 
Potential Benefits 
There is potential for improvement in mental health and quality of life of the caregiver due to practicing 
the skills taught as part of the intervention and coaching received. The skills are designed to reduce 
interpersonal conflict between caregiver and PLWD as well as to increase participation in pleasant 
activities.  
It is anticipated that this research will yield important new information regarding alternatives to 
antipsychotic medication use in persons with dementia. The results of this study will also serve to give 
doctors and caregivers of this population with more effective tools for managing troublesome and 
stressful behavior problems in this group of patients 
10.3 
Institutional Review Board 
The protocol and project materials for providers and patients and caregivers have been submitted to the 
KPWHRI IRB and approved.  Amendments require review and approval by the IRB before the changes 
are implemented.   
10.4 
Subject Confidentiality 
Appropriate steps will be taken to safeguard participant confidentiality.  This includes the following: 

STAR Caregivers – Virtual Training and Follow-up 
Version 4 
Grant Number: 1 R01AG061926-01 
13 August 2024 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
 
• 
All project data will be maintained on secure, password protected servers at clinical sites.  Only 
project staff needing this information for their work will have access. Members of the study 
team include Epic programmers from the delivery system;  
• 
Participants will be identified using only subject ID in any study analytic database(s) at each site; 
• 
The protocol, documentation, data and all other identifying information will be held in strict 
confidence.  No information about the project will be released without prior approval of NIA.  
Authorized representatives of the NIA may inspect records, as needed. 
10.5 
Future Use of Identifiable Data 
Identifiable information will be destroyed within 5 years of the end of the study, consistent with 
funding, HIPAA and IRB requirements. 
We have no plans to retain identifiable information beyond this period.  If this plan changes, we will 
obtain appropriate IRB approval. 
 

STAR Caregivers – Virtual Training and Follow-up 
Version 4 
Grant Number: 1 R01AG061926-01 
13 August 2024 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
 
11 DATA HANDLING AND RECORD KEEPING 
11.1 
Data Management Responsibilities 
Both institutional and application level access granted by the local information security office and 
simultaneous knowledge of both a valid username and password are required to access data collected in 
electronic records. Any paper records generated with patient identifying information will be kept in 
locked filing cabinets in secured office buildings. 
No participant data shall be overwritten by project staff.  As necessary, variables may be recoded into 
new variables for analyses, so as to preserve the original record. All changes will be documented. 
Final datasets will be saved electronically, clearly labeled and stored in a secure project folder on the 
KPWHRI server accessible only to project staff.   
11.2 
Data Capture Methods 
The majority of data for this pragmatic study is captured electronically in REDCap, including study 
enrollment, note taking by coaches, and collection of baseline and outcome measures. All information 
entered into the REDCap questionnaires by participants is stored behind the KPWRHI firewall. 
Cost and utilization data will be collected from the KPWHRI virtual data warehouse. 
All electronic records will be kept in a 21 CFR Part-11 compliant data capture system, which includes 
password protection. 
11.3 
Study Records Retention 
Identifying information and linking files will be destroyed within 5 years of the conclusion of the project 
unless consent to retain these files is granted by the IRB. Following this time, no other records will be 
destroyed without the consent of NIA. It is the responsibility of NIA to inform the investigator when 
these documents no longer need to be retained. 

STAR Caregivers – Virtual Training and Follow-up 
Version 4 
Grant Number: 1 R01AG061926-01 
13 August 2024 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
 
12 DATA SHARING PLAN 
Data and resource sharing are an integral part of the STAR-VTF research program.  
 
12.1 
Data Sharing Experience 
We at KPWHRI have a long history of sharing data with investigators locally and at other institutions and 
strongly support NIA’s effort to promote data sharing of results of publicly funded research to scientists 
in the US and elsewhere, with due respect for confidentiality and privacy. Our success supporting these 
projects is built on the understanding that effective data sharing means providing more than just data – 
it means offering programmatic and scientific support through an iterative process tailored to the needs 
of our external collaborators to help them understand and appropriately interpret data. Our data 
sharing philosophy ensures the highest quality science while safeguarding the protection of data on 
STAR-VTF participants. 
 
12.2 
Data and Resource Sharing Plan 
Completely de-identified datasets will be available for download. These will be based on published 
STAR-VTF papers and include documentation needed to ensure reproducibility. These data sets will be 
easily accessible with clear documentation of included variables. Custom datasets will be available upon 
request from the STAR-VTF team to support ancillary studies, collaborative meta-analyses, and external 
studies. 
Below we describe how we meet the five elements of NIA’s Guidance on Data Sharing.(25) 
 
12.2.1 
Access - STAR-VTF Repository and Data Sharing Capacity 
We will make completely de-identified study data available on the National Archive of Computerized 
Data on Aging (NACDA)(26) following the Guide to Social Science Data Preparation and Archiving(27). 
We will transform SAS files into comma delimited text files so that the data can be used in a variety of 
statistical software packages.  
Each participant will have a unique study identification number linking tables for demographic data, 
item and total scores for standardized instruments, healthcare utilization, and pharmacy utilization. All 
dates will be transformed to “days relative to randomization”. Cost data will be standardized to the 
Medicare fee-for-service fee schedule to protect financial data.  
We will also publish a data dictionary providing metadata descriptions in accompanying excel and pdf 
formats. Each variable will have a unique name, English language description, and description of its type 
(string, numeric) and length. 
 

STAR Caregivers – Virtual Training and Follow-up 
Version 4 
Grant Number: 1 R01AG061926-01 
13 August 2024 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
 
12.2.2 
Timetable for Data Release 
We will make the study data available prior to the online publication of the primary outcomes 
manuscript. 
 
12.2.3 
Restrictions to Data Sharing 
We do not share data in any manner that may be deemed commercial or seen as selling data. Prior to 
downloading data, investigators will be required to make written application for our approval. Such 
approval shall not be unreasonably withheld provided the data will be used for public interest research 
or for the purposes of validating our reported findings. 
Clinical notes that interventionists use to coach study participants will not be included in the publicly 
available data.  
 
12.2.4 
Data Deidentification Procedures 
Respecting privacy and minimizing risk of identifiable information disclosure of participants is of utmost 
importance. We have well-developed internal policies and procedures in place to make sure that 
confidentiality is maintained. We will build on KPWHRI’s existing secure data architecture and 
management systems to accommodate new data. When data are transferred NACDA, the PI will work 
closely with the Director of Data Programming and IT and the KPWHRI IRB to ensure data are protected 
to be compliant with HIPAA and IRB requirements. Prior to transfer from KPWHRI, a dedicated 
programmer and biostatistician pair with knowledge of the data will pre-review files to ensure 
compliance with regulations, alignment of data elements with permissions, and use of strategies to 
mitigate re-identification risk. Structured data extracted from source data will be transferred as either 
comma delimited text or SAS files.  
Unique identification numbers are assigned to all participants. Only the PI and designated programmer 
will have access to the participant's actual identification on an as-needed basis. All data collected for 
analytic purposes will be filed separately from clinical information, which may include participant 
names. Participant privacy and confidentiality will be protected through the creation of limited data sets 
and, where possible, data sets that are de-identified in accordance with the HIPAA Privacy Rule. Data 
will be transferred via KPWHRI’s web-based secure file transfer (SFT) application, which uses the 128-bit 
Secure Sockets Layer encryption protocol, the standard for secure Internet information transfer, and 
meets the 2009 HIPAA HITECH safe harbor standard. Data will be maintained locally in password 
protected files located in a secure server with restricted access.  
Within KPWHRI, only authorized project staff can access identifiable data. EHR data from KPWA systems 
and research data from other Cores will be stored in the KPWA Data Warehouse with unique 
anonymous encrypted identifiers that cannot be linked to KPWA identifiers without specific 
programming. Data handling procedures will be clearly documented and comply with KPWA guidelines 
for data storage, transfer, and destruction.  

STAR Caregivers – Virtual Training and Follow-up 
Version 4 
Grant Number: 1 R01AG061926-01 
13 August 2024 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
 
 
12.2.5 
Data Curation and Documentation 
We will employ robust quality processes to identify and correct errors for STAR-VTF Repository 
elements. Structured data from the KPWHRI virtual data warehouse, captured as electronic health 
record (EHR) data from KPWHRI’s instance of Clarity, or study data collected via REDCap will undergo 
comprehensive quality assurance to: (1) confirm that values fall within valid ranges and are internally 
consistent with related variables; (2) quantify levels of missing responses, accounting for complex skip 
patterns when relevant; and, (3) visualize temporal patterns in data elements to uncover unexpected 
trends, for instance from ICD-10 coding changes. Data quality concerns will be investigated fully by the 
study programmer and biostatistician in partnership with the PI and project manager. Corrective actions 
will be taken, and data rechecked to confirm issue resolution before certification. 
Once clean structured data elements are procured for each data domain, the programmer and 
biostatistician pair will collaborate with the PI and project manager to derive, validate, and provide 
detailed documentation of analytic variables relevant to address all project aims. Documentation in each 
case will include an exhaustive, user-friendly data dictionary that describes variable definitions, coding, 
construction, and usage. This documentation will guide all potential users in efficiently and 
appropriately using the data for analysis and sharing.  
Data files will be accompanied by statistical summaries of key features of the data and a curated suite of 
SAS programs that can be used and adapted to produce other potential summaries of interest or to 
generate different types of analysis-ready files. These summaries and documentation of variables and 
linked datasets will be available on the NACDA website. This process ensures that accessible and easy-
to-use data can be leveraged to produce transparent and reproducible analyses with the most up-to-
date and quality-controlled information available.  
12.3 
Data Sharing Summary 
In summary, we agree with the NIA that the best means to maximize the value of investments made in 
this study is to share the data as widely as possible. We are thoroughly committed to data sharing, are 
proud of our accomplishments to date in this area and look forward to continuing to broadly collaborate 
and share KPWHRI data and resources under the STAR-VTF project. 
 
 

STAR Caregivers – Virtual Training and Follow-up 
Version 4 
Grant Number: 1 R01AG061926-01 
13 August 2024 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
 
13 REFERENCES 
1. 
Moschetti K, Cummings PL, Sorvillo F, Kuo T. Burden of Alzheimer's disease-related mortality in 
the United States, 1999-2008. J Am Geriatr Soc. 2012;60(8):1509-14. Epub 2012/08/07. 
2. 
Association As. 2014 Alzheimer's Disease Facts and Figures. Alzheimer's & dementia : the journal 
of the Alzheimer's Association. 2014;10(2):67. 
3. 
Hebert LE, Weuve J, Scherr PA, Evans DA. Alzheimer disease in the United States (2010-2050) 
estimated using the 2010 census. Neurology. 2013;80(19):1778-83. Epub 2013/02/08. 
4. 
Weuve J, Hebert LE, Scherr PA, Evans DA. Deaths in the United States among persons with 
Alzheimer's disease (2010-2050). Alzheimer's & dementia : the journal of the Alzheimer's 
Association. 2014;10(2):e40-6. Epub 2014/04/05. 
5. 
Wang PS, Schneeweiss S, Avorn J, Fischer MA, Mogun H, Solomon DH, et al. Risk of death in 
elderly users of conventional vs. atypical antipsychotic medications. N Engl J Med. 
2005;353(22):2335-41. Epub 2005/12/02. 
6. 
Association AP. Choosing Wisely: Five Things Physicians and Patients Should Question. Available 
from: http://www.choosingwisely.org/doctor-patient-lists/american-psychiatric-association/. 
7. 
Society AG. Choosing Wisely: Five Things Physicians and Patients Should Question. 
8. 
Aging Ao. Managing Difficult Behaviors: A Standardized Intervention to Help Family Caregivers 
(STAR-C): An Evidence-Based Intervention for Alzheimer's and Dementia Care. 
9. 
Teri L, McCurry SM, Logsdon R, Gibbons LE. Training community consultants to help family 
members improve dementia care: a randomized controlled trial. Gerontologist. 2005;45(6):802-
11. Epub 2005/12/06. 
10. 
Teri L, McCurry SM, Logsdon RG, Gibbons LE, Buchner DM, Larson EB. A randomized controlled 
clinical trial of the Seattle Protocol for Activity in older adults. J Am Geriatr Soc. 
2011;59(7):1188-96. Epub 2011/07/02. 
11. 
Logsdon RG, McCurry SM, Teri L. A home health care approach to exercise for persons with 
Alzheimer's disease. Care Manag J. 2005;6(2):90-7. Epub 2006/03/21. 
12. 
Logsdon RG, McCurry SM, Teri L. STAR-Caregivers: a community-based approach for teaching 
family caregivers to use behavioral strategies to reduce affective disturbances in persons with 
dementia. Alzheimers Care Q. 2005;6(2):146-53. 
13. 
Gitlin LN, Belle SH, Burgio LD, Czaja SJ, Mahoney D, Gallagher-Thompson D, et al. Effect of 
multicomponent interventions on caregiver burden and depression: the REACH multisite 
initiative at 6-month follow-up. Psychol Aging. 2003;18(3):361-74. Epub 2003/10/02. 
14. 
O'Connor CM, Clemson L, Brodaty H, Jeon YH, Mioshi E, Gitlin LN. Use of the Tailored Activities 
Program to reduce neuropsychiatric behaviors in dementia: an Australian protocol for a 
randomized trial to evaluate its effectiveness. Int Psychogeriatr. 2014;26(5):857-69. Epub 
2014/02/11. 
15. 
Basu R, Hochhalter AK, Stevens AB. The Impact of the REACH II Intervention on Caregivers' 
Perceived Health. J Appl Gerontol. 2013. Epub 2014/03/22. 
16. 
Belle SH, Burgio L, Burns R, Coon D, Czaja SJ, Gallagher-Thompson D, et al. Enhancing the quality 
of life of dementia caregivers from different ethnic or racial groups: a randomized, controlled 
trial. Ann Intern Med. 2006;145(10):727-38. Epub 2006/11/23. 
17. 
Mittelman MS, Bartels SJ. Translating research into practice: case study of a community-based 
dementia caregiver intervention. Health Aff (Millwood). 2014;33(4):587-95. Epub 2014/04/09. 
18. 
McCurry SM, Teri L, Logsdon RG, La Fazia DM, Mead J, Stevens LA, et al. STAR-C MOVING FROM 
RCT TO TRANSLATION - INITIAL FINDINGS FROM OREGON AND BEYOND. Gerontologist. 
2012;52:296-7. 

STAR Caregivers – Virtual Training and Follow-up 
Version 4 
Grant Number: 1 R01AG061926-01 
13 August 2024 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
 
19. 
Morrison K, Winter L, Gitlin LN. Recruiting Community-Based Dementia Patients and Caregivers 
in a Nonpharmacologic Randomized Trial: What Works and How Much Does It Cost? J Appl 
Gerontol. 2014. Epub 2014/05/07. 
20. 
Teri L, Gibbons LE, McCurry SM, Logsdon RG, Buchner DM, Barlow WE, et al. Exercise plus 
behavioral management in patients with Alzheimer disease: a randomized controlled trial. 
JAMA. 2003;290(15):2015-22. Epub 2003/10/16. 
21. 
Teri L, Huda P, Gibbons L, Young H, van Leynseele J. STAR: a dementia-specific training program 
for staff in assisted living residences. Gerontologist. 2005;45(5):686-93. Epub 2005/10/04. 
22. 
Wagner EH, Ludman EJ, Aiello Bowles EJ, Penfold R, Reid RJ, Rutter CM, et al. Nurse navigators in 
early cancer care: a randomized, controlled trial. J Clin Oncol. 2014;32(1):12-8. Epub 
2013/11/28. 
23. 
Rotnitzky A, Robins JM. Semiparametric regression estimation in the presence of dependent 
censoring. Biometrika. 1995;82(4):805-20. 
24. 
Rubin DB. Multiple imputation for nonresponse in surveys. New York: J Wiley & Sons; 1987. 
25. 
National Institute on Aging. NIA-specific funding policies. 2020 [cited 2020 April 19]; Available 
from: nia.nih.gov/research/grants-funding/nia-specific-funding-policies. 
26. 
NACDA - National Archive of Computerized Data on Aging.  [May 29, 2020.]; Available from: 
https://www.icpsr.umich.edu/web/pages/NACDA/deposit.html. 
27. 
Inter-university Consortium for Political and Social Research Inter-university Consortium for 
Political and Social Research. Guide to Social Science Data Preparation and Archiving. Best 
Practice Throughout the Data Lifecycle. 6th Edition.  [May 29, 2020.]; Available from: 
https://www.icpsr.umich.edu/files/deposit/dataprep.pdf.