Cluster Randomized Controlled Trial to Test the Efficacy of a Psychosocial Intervention (REACH VN) to Support Alzheimer's Family Caregivers in Vietnam
Phase: NA
Conditions: Dementia
Sponsor: University of California, Davis

 
 
 
 
 
 
 
 
 
 
 
Study Title: Cluster Randomized Controlled Trial to Test the Efficacy of a Psychosocial 
Intervention (REACH VN) to Support Alzheimer's Family Caregivers in Vietnam 
NCT#: NCT04542317 
Document Date: May 23, 2023 
Document Type: Study Protocol 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

PROTOCOL TITLE: Cluster Randomized Controlled Trial to Test the Efficacy of a 
Psychosocial Intervention (REACH VN) to Support Alzheimer's Family Caregivers in 
Vietnam 
Page 2 of 12 
 
Revised: May 23, 2023 
 
1) Protocol Title 
Title:  Cluster RCT to test the efficacy of a psychosocial intervention to support 
Alzheimer’s family caregivers in Vietnam 
Protocol Version Date: 5/23/2023 
2) Objectives 
The objective of this study is to conduct a cluster randomized controlled trial to 
test the efficacy of a psychosocial intervention to support Alzheimer’s family 
caregivers in Vietnam. The cluster RCT will test the hypothesis that family 
caregivers who receive the intervention will show lower psychological distress 
and lower caregiver burden compared with those in the control group (primary 
outcomes). In addition, we will conduct secondary analyses to examine whether 
intervention group has lower perceived stress and somatic symptoms.  
Exploratory analyses will be conducted to determine if intervention effects are 
mediated by caregiver self-efficacy or knowledge gain. 
3) Background 
 
Low and middle-income countries (LMIC) such as Vietnam are undergoing a 
dramatic demographic transition that will result in a substantial increase in the 
number of older adults, including those afflicted with Alzheimer’s disease and 
related dementias, over the next several decades. Dementia is among the most 
disabling and costly neurodegenerative brain diseases. Strengthening LMIC 
capacity to support family caregivers of persons with dementia through low-cost 
and sustainable non-pharmacological approaches, such as education and skill-
building to deal with difficult behaviors, is vital to avoid costly and ineffective 
alternatives such as psychotropic medications or institutionalization, and to reduce 
caregiver burdens and depression. While evidence-based non-pharmacological 
treatments exist in high income countries (HIC), these interventions have not been 
adapted for use in Vietnam and other LMIC.  
 
This project addresses these gaps by testing a community-based and culturally 
adapted behavioral family caregiver intervention for use in Vietnam. The 
intervention has several components (psychoeducation, stress reduction, skill-
building) and is designed to reduce caregiver stress and burden. This project also 
builds directly on a pilot cluster RCT that found evidence for feasibility and 
preliminary efficacy of the intervention. 
 
4) Inclusion and Exclusion Criteria 
To be eligible for the cluster RCT, the family member will need to be the 
identified adult (age 18 and above) primary caregiver (i.e., the person spending 
who provides the most time day-to-day providing care) to an older adult with 
dementia who is living in the community. In the event that the primary caregiver  

PROTOCOL TITLE: Cluster Randomized Controlled Trial to Test the Efficacy of a 
Psychosocial Intervention (REACH VN) to Support Alzheimer's Family Caregivers in 
Vietnam 
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Revised: May 23, 2023 
 
is not available to participate, an alternate family member who providing 
substantial (i.e., at least 4 hours/day) of care to the older adult with dementia will 
be eligible. Caregivers will need to score ≥ 6 on the Zarit Burden Inventory 4-
item version. All participants will be living in designated clusters in Hai Duong, 
Vietnam. To be eligible, clusters will have a minimum of 5 participants and a 
maximum of 15 participants. Clusters will be defined as geographic areas serving 
local health stations. 
The final sample for the cluster RCT will be 350 family caregivers of persons 
diagnosed with dementia (175 in the active intervention and 175 in the control 
group). The RCT will exclude: 
• Caregivers who are unable to consent 
• Individuals who are not yet adults (infants, children, teenagers) 
• Prisoners 
5) Study Timelines 
• We will begin recruitment in August of 2020. 
• We will complete recruitment by September of 2023.  
• We will complete all data collection and intervention activities by March of 
2024. 
• We will complete preliminary analysis of the data by August of 2024. 
6) Study Endpoints 
This is a time-limited intervention lasting up to 3 months with independent 
assessment of outcomes at baseline, 3 months, and 6 months.   
7) Procedures Involved 
The study will be conducted in two districts in Hai Duong, a province located 
near Hanoi, Vietnam. Clusters within both districts will be defined as geographic 
areas served by local health clinics (commune health stations). In collaboration 
with commune health stations, community-based screening will be conducted to 
identify Alzheimer’s family caregivers residing in the designated clusters who 
will then be invited to participate in the study. Clusters will be randomly assigned 
to either the intervention (approximately 21 clusters, 175 caregivers) or to the 
enhanced control condition (approximately 21 clusters, 175 caregivers).  
Staff from the National Geriatric Hospital and Hai Duong Provincial Hospital will 
train local staff (e.g., village health workers) to identify persons at high risk for 
dementia from their caseloads, including those with a history of significant 
memory problems, behavioral issues and evidence of functional decline.  
Research staff from local health clinics will contact potential participants by 
phone, provide information about the project, and invite them to participate in  

PROTOCOL TITLE: Cluster Randomized Controlled Trial to Test the Efficacy of a 
Psychosocial Intervention (REACH VN) to Support Alzheimer's Family Caregivers in 
Vietnam 
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Revised: May 23, 2023 
 
screening to determine their elibility. Verbal consent will be obtained from the 
older adult and a family member prior to screening by research staff. Those who 
consent to participate in the screening will undergo an assessment including a 
brief neurological exam, bedside cognitive testing and dementia stage using 
standard instruments, including the Mini-Cog, NPI-Q and CDR. Once an older 
adults has been determined to meet criteria for dementia (i.e, CDR≥1), we will 
identify the adult family member providing the most day-to-day care and invite 
them to participate in the study and obtain verbal consent. Because of the minimal 
risk of both screening and behavioral intervention, verbal consent will be obtained 
for both.  
Family caregivers in the intervention will receive a manualized intervention that 
will consist of 3-6 one-hour sessions with a trained staff (e.g. nurse, social 
worker, or community health worker) who has been certified to deliver the 
intervention. The sessions will be administered at home (or other setting of the 
subject’s choice such as a clinic) or by phone and include several components, 
including psychoeducation, stress reduction, skill-building. The intervention will 
be tailored to the needs and preferences of the caregiver. As part of the 
intervention, participants will receive a caregiver notebook with information 
about dementia and management of common problems. Participants in the control 
clusters will receive a single session in which they will receive education about 
Alzheimer’s disease including written materials.  
Outcomes will be assessed by research staff from the Institute of Population 
Health and Development who are masked to allocation. Participants in both 
clusters will be assessed at baseline, 3 months, and 6 months to assess primary 
and secondary outcomes using standardized instruments, including the PHQ-4, 
Zarit Burden Interview-12, Perceived Stress Scale-10, PHQ-15 (a somatic 
symptoms scale). In addition, we will assess two different potential mediators 
using the Caregiving Self-Efficacy Scale and Dementia Knowledge Scale.  
Assessments will be conducted by research staff who are masked to allocation.   
The interventionists will follow a manual (Interventionist Manual) that includes 
scripts, detailed descriptions of the goals for each session, and standardized forms. 
The interventionists will provide the caregivers with a detailed notebook with 
helpful cargiving information (Caregiver Notebook). 
For training purposes only and quality control of the intervention, we will audio 
record a subsample of the intervention sessions. These audio recordings will be 
stored securely and will not be linked to participant’s name or other identifying 
information. These will not be used for research purposes. The recordings will be 
reviewed within 6 months and then destroyed. Participants may continue their 
participation in this study without consenting to these recordings and having any 
impact on their participation. 
 
 

PROTOCOL TITLE: Cluster Randomized Controlled Trial to Test the Efficacy of a 
Psychosocial Intervention (REACH VN) to Support Alzheimer's Family Caregivers in 
Vietnam 
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Revised: May 23, 2023 
 
8) Data and/or Specimen Management and Confidentiality  
REDCap will be used to collect outcomes data. Procedures for maintenance and 
confidentiality include 1) assigning each participant a unique identifier, 2) data 
collected will be labeled using the unique identifier and will be stored separately 
from the key linking personal information (e.g. name, date of birth, address, 
phone number) and identifiers, 3) data will be kept or on a secure server that is 
only accessible to research staff, 4) at the conclusion of the study, the key linking 
identifiers and personal information will be destroyed, 5) all research personnel in 
the U.S. who have access to the patient data will receive training on conducting 
human research (e.g. NIH online course) – all investigators in Vietnam will 
participate in the local equivalent of this training.  
 
9) Data and/or Specimen Banking 
  
a) Will the data or specimens ever be used by you or other researchers to answer a 
different research aim that is not included in this study? 
☒ Yes - Complete the remainder of Section 9. 
☐ No - Do not complete Section 9. Go to section 10. 
 
b) What will be banked for future use? 
☒ De-identified data/specimens. Banked data/specimens cannot be linked to an 
individual. 
☐ Identifiable data/specimens – Banked data/specimens will include 
identifying information. 
☐ Coded data/specimens – Banked data/specimens will be stripped of 
identifiers and assigned a code. A key will be maintained that links the 
identifiers to the data/specimens. 
☐ Contact information will be banked for future research opportunities. 
 
c) Where will the data/specimens be banked?   
Computer files are password protected, and data are maintained on a secure 
firewall-protected network of the UC Davis Health System, REDCap.  
 
d) How long will the data/specimens be banked?  
After the study, the key linking personal identifiers to the survey data will be 
destroyed. De-identified data will be kept indefinitely. 
 
e) Who will have access to the banked data/specimens?  
Only select researchers involved in the project will have access to these data. 
Only de-identified data will be shared to other researchers who wish to access 
banked data.   

PROTOCOL TITLE: Cluster Randomized Controlled Trial to Test the Efficacy of a 
Psychosocial Intervention (REACH VN) to Support Alzheimer's Family Caregivers in 
Vietnam 
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Revised: May 23, 2023 
 
f) Describe the procedures to release data/specimens. Include the process to 
request a release, approvals required for release, who can obtain data/specimens, 
and the data/specimens to be provided.  
 
 
- Recipient investigators who wish to access banked data will need to contact 
PIs (Dr. Ladson Hinton and Dr. Huong Nguyen) for an inquiry. 
 
- If PIs agree for accessing banked data, the following approval steps will be 
taken: 
+ Recipient investigators will submit a proposal to PIs with the following 
information: 
• Title 
• Recipient PI’s contact information and team members/co-authors 
• Introduction 
• Research questions 
• Data variables  
• Analysis plan 
• References 
+ Recipient investigators will submit an IRB approval letter from their 
local institution. 
+ PIs will submit the UC Davis Data Use Agreement request to UC Davis 
Innovation Access for recipient investigators to complete the Data Use 
Agreement Form. 
+ After recipient investigators receive approval documents, de-identified 
data will be transferred to them electronically through a password 
encrypted zip file. 
 
- Recipient investigators are: 
+ required to safeguard data provided to them and ensure 
deletion/destruction of the data upon completion of their project 
+ restricted from attempting to identify participants using the data 
provided to them 
+ restricted from presenting data in any manner which could identify 
participants 
+ restricted from further distribution of the data. 
+ required to acknowledge the funding in any publication or presentation 
“Research reported in this publication was supported by the National 
Institute on Aging (NIA) of the National Institutes of Health (NIH) under 
award number R01AG064688 (Hinton/Nguyen MPI). The content is 
solely the responsibility of the authors and does not necessarily represent 
the official views of the NIA and the NIH.” 
 
 
 

PROTOCOL TITLE: Cluster Randomized Controlled Trial to Test the Efficacy of a 
Psychosocial Intervention (REACH VN) to Support Alzheimer's Family Caregivers in 
Vietnam 
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Revised: May 23, 2023 
 
Note: Identifiable protected health information extracted from the UCDH EMR 
under an IRB-issued waiver of HIPAA Authorization may not be re-
disclosed/released outside the study team. 
 
 
10) Provisions to Monitor the Data to Ensure the Safety of Subjects 
 
The goal of this cluster randomized controlled trial care is to assess the efficacy of 
the psychosocial intervention to support Alzheimer’s family caregivers. Case 
review will occur on a weekly basis with a team that includes the care manager 
and the local PI and investigators from the UC Davis and UMN. The caregiver’s 
level of distress and any indicators of elder abuse/neglect will be reviewed at each 
session.  
 
This study will have a Safety Office (SO), who will meet 1-2 times each year to 
review the progress of the study, including adverse events, procedures for 
maintaining the confidentiality of data, and the quality of data collection, 
management, and analyses. The SO will also review any issues that arise in terms 
of conflict of interest. or serious adverse events as needed. The SO will report 
directly to the funder (i.e., NIA). 
 
Dr. Hinton will be responsible for overall monitoring and appropriate reporting of 
adverse events including serious adverse events that occur during the study. Plans 
regarding reporting of adverse events will follow guidelines and policies of UC 
Davis as well as NIH. Adverse events will include events untoward or 
unfavorable mental or physical health-related occurrence in a human subject that 
is temporally associated with the subject’s participation in the research, regardless 
of whether they are considered related to the subject’s participation in the 
research. Examples of such events that might occur include incidents of brief 
hospitalization, caregiver distress or depression, instances of elder abuse or 
neglect, and other unanticipated events. Serious adverse events will be further 
defined as those events that seriously jeopardize the participant’s health, including 
prolonged hospitalization, suicide attempts, and death. The overall goal of this 
plan is to have both serious adverse events (SAE) and non-serious adverse events 
(NSAE) that are viewed as likely (i.e., 50% or higher) related to study 
participation reported to both the UCD IRB and NIH in a timely fashion.  
 
As a routine part of training, intervention study staff will be educated to monitor 
for these events and to report them to the research staff.  Interventionists or other 
research staff will complete AE Field Report Form and provide this to Hai Duong 
project lead (i.e, Dr. Bien) within 48 hours. Dr. Bien will send all AE Field Report 
Forms to NGH RCT leads (i.e, Dr. Ngoc and Dr. Hung), and the interventionist 
supervisors within 48 hours. Upon receiving the report from Dr. Bien, Dr. Ngoc 
must confirm that she has received the report and is available to act upon it. Dr. 
Ngoc will review AE Field Report Form, complete AE Form and, if it is a SAE,  

PROTOCOL TITLE: Cluster Randomized Controlled Trial to Test the Efficacy of a 
Psychosocial Intervention (REACH VN) to Support Alzheimer's Family Caregivers in 
Vietnam 
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Revised: May 23, 2023 
 
complete SAE Form and send to study PIs (Dr. Hinton, Dr. Huong Nguyen, and 
Dr. Trung Anh) within 48 hours. Dr. Hung will serve as back-up in Dr. Ngoc is 
not available. Within 2 working days of receipt of the information about the SAE, 
Dr. Hinton will share this information with the research team and the SO. If the 
SAE is viewed as likely (i.e., >50% probability) of being related to participation 
in the study, the SAE will be reported to the UCD IRB and to NIH within 2 
working days of this determination with the goal of reporting all such events to 
UCD IRB and to the NIH PO within 5 working days of the time Dr. Hinton 
became aware of the event. NSAE will be shared with the core members of the 
research team, including Drs. Hinton, Trung Anh  and Huong Nguyen, at their 
regular biweekly meetings. If NSAE are deemed as possibly related to study 
participation they will be reported to the SO within one week and, if the SO views 
them as “probably” (i.e., >50% likelihood) of being related to study participation, 
to the UCD IRB and NIH PO within 5 working days. All SAE and NSAE that are 
viewed as not likely to be related to research participation will be reported on an 
annual basis to the NIH PO as part of the progress report as well as to the 
institutional IRBs.  
 
11) Withdrawal of Subjects 
 
Subjects (patients and family members) may withdraw at any time. If they 
withdraw from the study, they will be given the option of having their records 
destroyed. 
 
12) Risks to Subjects 
 
The main risks associated with this study: 1) discomfort or mild distress because 
of the intervention, 2) inconvenience because of the need to fill out the study 
questionnaires, and 3) loss of confidentiality. These risks are similar to the risk of 
undergoing routine assessments in healthcare clinics in Vietnam. Specific steps 
are being taken to address each category of risk.  
 
Discomfort due to the intervention: Even though this study builds on evidence-
based strategies for support of family caregivers, subjects may experience 
discomfort or mild distress when discussing their caregiving experience or 
because of concerns about confidentiality. These risks will be minimized in 
several ways. Interventionists will be trained to enhance their skills to be 
empathic listeners to create an emotionally comfortable environment for family 
caregivers. Interventionist will be trained to remind patients that they are not 
required to answer any questions and can withdraw from the intervention at any 
time or choose to end a session early. For extreme situations of emotional stress 
(e.g., involving threats of self-harm), interventionists will have an established 
protocol in emergency situations to minimize risk of harm.  

PROTOCOL TITLE: Cluster Randomized Controlled Trial to Test the Efficacy of a 
Psychosocial Intervention (REACH VN) to Support Alzheimer's Family Caregivers in 
Vietnam 
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Revised: May 23, 2023 
 
Inconvenience due to questionnaires: To address the inconvenience associate with 
completing study questionnaires, we will give subjects the option of completing 
these in the home or by phone. In addition, during the consent process, 
participants will be advised that they can choose not to answer any questions that 
make them feel uncomfortable. Risks to subjects are minimal for several reasons.  
 
Loss of confidentiality: Steps will also be taken to protect against risk regarding 
loss of confidentiality which is particularly important in Vietnam where staff may 
not be as familiar with research and the importance of confidentiality. All staff 
will receive training and education about the importance of maintaining 
confidentiality as a core aspect of the research to minimize of risk. When 
conducting interviews, staff will try to maintain a private space and discuss the 
participant’s level of comfort in talking to the interviewer or interventionist if 
others are within earshot. In the consent process, participants will be informed 
about loss of confidentiality as a risk and the precautions being taken to minimize 
this.  
Other: This is a behavioral intervention and does not involve drug treatment. In 
prior studies conducted with multi-cultural populations in the United States, there 
have not been any serious adverse side events attributable to the intervention 
(personal communication with one of the PIs of a large-scale national study).  
Similarly, in a pilot study there were no serious adverse events related to this 
intervention. It is also possible that elder/abuse or neglect may be detected during 
the study and require intervention. A protocol for handling cases of abuse/neglect 
according to local norms/resources has been developed in collaboration with our 
colleagues in Vietnam. 
13) Potential Benefits to Subjects 
There are several potential direct benefits to subjects. Subjects may experience an 
increase in their knowledge and skills because of the intervention. In addition, 
caregivers will learn stress reduction techniques that may help reduce caregiving-
related distress. Older adults participating in screening will be given the option of 
having information about their cognitive testing be provided to their primary care 
physician.  
Participants will receive $4 at the end of the screening session and $8 at the end of 
each study visit (including intervention sessions and visits for administration of 
assessments). 
14) Multi-Site Research 
 
This is a single-site, multiple PI, international study with Dr. Hinton as the lead 
investigator. Approval for the study will be obtained by both the UC Davis IRB 
and the Vietnam National Geriatric Hospital IRB. Dr. Hinton will be responsible 
for coordinating with the international site to ensure that the most current version 
of the protocol and consent document are used. He will work with the PI at the 
Vietnam National Geriatric Hospital to ensure that 1) Participating sites will  

PROTOCOL TITLE: Cluster Randomized Controlled Trial to Test the Efficacy of a 
Psychosocial Intervention (REACH VN) to Support Alzheimer's Family Caregivers in 
Vietnam 
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Revised: May 23, 2023 
 
safeguard data as required by local information security policies, 2) All local site 
investigators conduct the study appropriately, and 3) All non-compliance with the 
study protocol or applicable requirements will reported in accordance with local 
policy. 
 
15) Community-Based Participatory Research 
NA 
 
16) Provisions to Protect the Privacy Interests of Subjects 
Describe the steps that will be taken to protect subjects’ privacy interests. 
“Privacy interest” refers to a person’s desire to place limits on whom they interact 
or whom they provide personal information. 
Describe what steps you will take to make the subjects feel at ease with the 
research situation in terms of the questions being asked and the procedures being 
performed. “At ease” does not refer to physical discomfort, but the sense of 
intrusiveness a subject might experience in response to questions, examinations, 
and procedures. 
Indicate how the research team is permitted to access any sources of information 
about the subjects. 
17) Compensation for Research-Related Injury 
NA – minimal risk study 
 
18) Economic Burden to Subjects 
There are no costs that subjects may be responsible for because of participation in 
the research. 
19) Drugs or Devices 
NA 
 
20) ClinicalTrials.gov Registration 
 
Section 1:  NIH Funded Studies 
If yes to BOTH, the study must be registered on Clinicaltrials.gov. 
Yes  
 
This study is funded by the NIH. (If this study is not funded by NIH, go to 
Section 2.) 
 
One or more human subjects will be prospectively assigned to one or more 
interventions (which may include placebo or other control) to evaluate the effects 
of those interventions on health-related biomedical or behavioral outcomes. 
 
Section 2:  Studies subject to FDA jurisdiction 
If yes to ANY the study must be registered on Clinicaltrials.gov. 

PROTOCOL TITLE: Cluster Randomized Controlled Trial to Test the Efficacy of a 
Psychosocial Intervention (REACH VN) to Support Alzheimer's Family Caregivers in 
Vietnam 
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Revised: May 23, 2023 
 
 
Yes 
 
 
This is a prospective clinical study of health outcomes in human subjects that 
compares an intervention with an FDA-regulated device against a control. This 
is not a small clinical trial to determine the feasibility of a device, or a clinical 
trial to test prototype devices where the primary outcome measure relates to 
feasibility and not to health outcomes. 
 
This is a pediatric postmarket surveillance of a device as required under section 
522 of the Federal Food, Drug, and Cosmetic Act. 
 
This is a controlled clinical investigation, other than a phase I clinical 
investigation, of a drug subject to section 505 of the Federal Food, Drug, and 
Cosmetic Act or to section 351 of the Public Health Service Act. 
To view a flowchart describing applicable clinical trials subject to FDA jurisdiction click 
here. 
 
Section 3: Publishing the results 
If yes to BOTH the study must be registered on Clinicaltrials.gov. 
Yes  
 
This study prospectively assigns people or a group of people to an intervention, 
with or without concurrent comparison or control groups, to study the cause-and-
effect relationship between a health-related intervention and a health outcome. 
 
The PI has access to and control over all the data from the clinical trial and has 
the right to publish the results of the trial and plans to publish the results in a 
journal that follows the ICMJE recommendations.  
This requirement includes studies of behavioral interventions. 
 
Section 4: Registration on Clinicaltrials.gov is not required 
Yes  
 
I have read sections 1-3 above and registration on clinicaltrials.gov is not required 
for this research.  
 
21) Criteria for 10 Year Approval  
 
If yes to all items below this research may qualify for a 10-year approval period. 
 
Yes  
 
This research involves no more than minimal risk. 
 
This research does not receive any federal or state government funding or funding 
from a private funder who requires annual review per contract. 
 
This research is not subject to FDA jurisdiction.  
 
This research does not include prisoners as participants. 

PROTOCOL TITLE: Cluster Randomized Controlled Trial to Test the Efficacy of a 
Psychosocial Intervention (REACH VN) to Support Alzheimer's Family Caregivers in 
Vietnam 
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Revised: May 23, 2023 
 
This research is not subject to SCRO oversight. 
 
This research is not subject to oversight by the Research Advisory Panel of 
California (RAP of C). 
 
This research does not involve identifiable information held by the State of 
California Department or Agency 
 
No personnel involved in the design, conduct, or reporting of this research have a 
new unreported related financial interest (RFI) in this study.