A Phone Intervention for Family Dementia Caregivers in Vietnam
Phase: NA
Conditions: Dementia
Sponsor: University of California, Davis

 
 
 
 
 
 
 
 
 
 
 
Study Title: A pilot cluster randomized controlled trial of a phone intervention 
supporting family caregivers of people living with dementia in Vietnam: Resources for 
Enhancing Alzheimer's Caregiver Health in Vietnam (REACH VN) 
NCT#: NCT05481320 
Document Date: November 16, 2022 
Document Type: Study Protocol 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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1) Protocol Title 
Title:  A Phone Intervention for Family Dementia Caregivers in Vietnam  
Protocol Version Date: 11/16/2022 
2) Objectives 
The objective of this study is to examine the feasibility, acceptability, and 
preliminary efficacy of the phone version of REACH VN, a psychosocial culturally 
adapted Alzheimer’s family caregiving intervention that will be delivered over the 
phone with an enhanced control as the comparison. The pilot cluster RCT will test 
the hypothesis that family caregivers who receive the intervention will show 
lower caregiver burden (primary outcome) and lower depressive/anxiety 
symptoms (secondary outcome) compared with those in the control group. 
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 (ADRD), over the next several decades. Dementia is among the 
most disabling and costly neurodegenerative brain diseases. Strengthening LMIC 
capacity to support family caregivers of people 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.  
 
Delivery of interventions through telehealth and other types of technology (e.g., 
online, mobile apps) holds considerable promise for the field because of lower 
costs and greater reach, particularly for those living in rural areas. These 
considerations are particularly important in Vietnam and other LMIC because 
most older adults reside in rural areas. With the rapid adoption of mobile phones, 
tablets, and smartphones, family caregiver interventions hold considerable 
promise for closing gaps in dementia care and services for these countries. The 
COVID-19 pandemic has also reinforced the need for interventions that can be 
delivered at a distance to maintain support for caregivers and reduce their social 
isolation.  
 
To our knowledge, our study will be the first study in Vietnam or other LMIC in 
Asia to examine the efficacy of multicomponent family caregiver intervention 
delivered remotely. The intervention has several components (e.g., 

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psychoeducation, stress reduction, skill-building) and is designed to reduce 
caregiver stress and burden. 
 
4) Inclusion and Exclusion Criteria 
Inclusion criteria:  
To be eligible to participate, a family member will need to be the identified adult 
(i.e., age 18 and above) who is the primary informal (i.e., unpaid family member) 
caregiver (i.e., the person who provides the most time day-to-day care) to an older 
adult (i.e., age 60 and above) with dementia living in the community. If the 
primary caregiver is not available to participate, an alternate family member who 
provides substantial care (i.e., at least 4 h/day) to an older adult with dementia 
will be eligible to participate. In addition, caregivers will need to score ≥ 6 on the 
Zarit Burden Interview-4 (ZBI-4). All participants will be living in clusters in 
Thach That District, a semi-rural area in Hanoi.  
Exclusion criteria: 
The study will exclude: 
• Caregivers with difficulties in the consent process due to cognitive 
impairment or severe sensory impairment (i.e., visual, hearing) 
• Caregivers don’t have access to phone 
• Individuals who are not yet adults (i.e., infants, children, teenagers) 
• Prisoners 
5) Study Timelines 
• We plan to begin recruitment in August of 2022. 
• We plan to complete recruitment by January of 2023.  
• We plan to complete all data collection and intervention activities by April of 
2023. 
• We plan to complete preliminary analyses of the data by July of 2023. 
6) Study Endpoints 
This is a time-limited intervention lasting up to 3 months with independent 
assessment of outcomes at baseline and 3 months. 
7) Procedures Involved 
Study design: A two arm, 3-month follow up, cluster randomized controlled trial 
of 60 caregivers (30 in REACH VN phone intervention group and 30 in enhanced 
control group) will be conducted. 
Setting: Thach That District, a semi-rural area in Hanoi, Vietnam. 
Recruitment:  

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In collaboration with commune health stations, community-based screening will 
be conducted to identify “at risk” older adults with dementia and their family 
caregivers.  
Staff from the National Geriatric Hospital (NGH) will train local staff (e.g., 
village health workers) to identify people at high risk for dementia from their 
caseloads, including those with a history of significant memory problems, 
behavioral issues and evidence of functional decline. Staff from local health 
clinics will contact potential participants by phone or in-person, provide 
information about the project, and invite them to participate in screening to 
determine their eligibility. Verbal consent will be obtained from an 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, cognitive testing and dementia stage using standardized 
instruments, including the Mini-Cog, NPI-Q, and CDR. The assessments will be 
conducted by physicians, neurologists, or healthcare professionals trained by 
NGH. Once an older adult has been determined to meet criteria for dementia (i.e., 
CDR ≥ 1), we will identify the adult family member who is providing the most 
day-to-day care and invite them to participate in a brief screening to determine 
their eligibility. If they are eligible, we will invite them to participate in the study 
and obtain verbal consent.  
A screening log will be kept to document number and reasons of participants who 
do not meet the inclusion criteria, decline to participate, or any other reasons.  
Consent: 
Because of the minimal risk of both screening and behavioral intervention, verbal 
consent will be obtained for both. As part of the consent process, all caregivers 
will be informed that this is a voluntary study and that they can withdraw at any 
time. 
Randomization: 
Communes will be the unit of randomization and randomization assignments will 
be generated using a block randomization function in R for each stratum with a 
1:1 ratio for two groups: intervention (n= approximately 8 clusters or 30 
caregivers) or enhanced usual care (n= approximately 8 clusters or 30 caregivers).  
The UC Davis Biostatistician will be responsible for generating randomization 
codes and assigning randomization codes to communes. The biostatistician will 
communicate cluster assignment to the principal investigator (PI) to convey to the 
study team in Vietnam of when communes have been randomized. 
Clusters will need to be in Thach That District and have a minimum of 3 
participants and a maximum of 15 participants. 
Blinding: 
A trained outcome assessor who conducts data collection will be blinded 
regarding group assignments. 
REACH VN Phone Intervention:  

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Family caregivers in the intervention will receive a manualized multicomponent 
intervention, including psychoeducation, stress reduction, and skill-building, that 
will consist of 4-6 “core” sessions with the option for 1-2 “maintenance” sessions 
based on caregiver needs and clinical judgment with a trained staff (e.g., nurse, 
social worker, or community health worker) who has been certified to deliver the 
intervention. Interventionists will follow the interventionist manual that includes 
scripts, detailed descriptions of the goals for each session, and standardized forms.  
The enrollment session (session 0) will be conducted face-to-face. Interventionists 
with village health workers will come to caregivers’ home to provide a caregiver 
notebook with information about dementia and management of common 
problems, check phone issues and signals, and conduct the risk priority intake 
assessment. The intervention sessions will be conducted over the phone with 
either audio or video call over the course of 1-3 months. The sessions will occur 
every 1–2 weeks depending on the needs and availability of family caregivers. 
Each intervention session will last between 30 minutes to an hour. In case 
caregivers are not able to concentrate on the session after the first 20-30 minutes, 
interventionists can end the session and make appointment to call back within 2-4 
days (or whenever it is possible) to complete the session.  
At the beginning of the intervention, we will emphasize to caregivers that text 
message is only allowed for scheduling or making changes to scheduled 
intervention times, not for other purposes. In case caregivers would like other 
family members to attend the intervention with them, interventionists will inform 
caregivers in advance that the intervention includes components that ask 
caregivers about caregiving difficulties, private psychological issues, or family 
problems; thus, it is up to caregivers to decide whether to include family members 
into the calls. If they feel comfortable sharing when there are with other family 
members, they may choose so to let other family members attend the intervention. 
However, if caregivers are not comfortable, we will advise them to attend the 
intervention by themselves.  
Quality control of the intervention 
At the end of each session, interventionists will complete a standardized treatment 
form (i.e., Interventionist Delivery Assessment (IA)) that summarizes the session 
either on REDCap or hardcopy. 
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 3 months and then destroyed. Participants may continue their 

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participation in this study without consenting to these recordings and having any 
impact on their participation. 
In general, a session will be conducted by one interventionist. However, in some 
cases, there will be another interventionist who will join the session as a 
supportive person to enhance the quality control of the intervention. 
Supervision of all interventionists will take place during a weekly supervision 
meeting (in-person or by phone) with senior members of the research team. 
Enhanced Control: 
Caregivers in the enhanced control group will receive a single phone session in 
which they will receive education about ADRD including written materials. 
Outcome assessments: 
A research assistant at the National Geriatric Hospital who is trained and certified 
will conduct outcome assessments over the phone. An outcome assessor will be 
masked to group assignment status. We will remind caregivers not to tell an 
outcome assessor their group assignment status to minimize bias. Caregivers in 
both groups will be assessed at baseline and 3 months. The primary outcome will 
be caregiver burden as assessed by the Zarit 6-item burden scale (ZBI-6) and the 
secondary outcome will be depressive/anxiety symptoms as assessed by the four-
item Patient Health Questionnaire (PHQ-4). We will use previously developed 
Vietnamese versions of study instruments. 
Feasibility, fidelity, and acceptability assessments:  
Feasibility metrics will include recruitment, randomization, retention, treatment 
adherence, treatment fidelity, and assessment processes. Fidelity assessment will 
be based on review of standardized treatment delivery forms completed by 
interventionists and an independent observer of a random subset of sessions. Prior 
to the RCT, interventionists who are already certified in face-to-face REACH VN 
intervention will need to be trained in phone delivery. Acceptability will be 
assessed through semi-structured interviews with a random subset of participants 
who have completed the intervention group (n=10) and REACH VN 
interventionists (n=5). These interviews will include questions on satisfaction, 
aspects of the intervention that participants found most helpful, challenges, and 
opportunities for improvement. We will inquire about any issues related to 
intervention delivery by audio or video call. 
Reimbursement:  
Participants will receive $4 (or 100,000 VND) at the end of the screening session 
and $8 (or 200,000 VND) at the end of each study visit/session (including 
intervention sessions and outcome assessments). 
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 

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from the key linking personal information (e.g., name, date of birth, address, 
phone number) and identifiers, 3) data will be kept 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 and research staff in 
Vietnam will participate in the local equivalent of this training.  
 
9) Data and/or Specimen Banking 
  
All data will be stored on a secure server at in Vietnam. De-identified data will be 
transferred to UC Davis and the University of Minnesota (UMN) electronically 
through an encrypted zip file. After the study, the key linking personal identifiers 
to the survey data will be destroyed. 
 
10) Provisions to Monitor the Data to Ensure the Safety of Subjects 
 
Case review will occur on a weekly basis with a team that includes the 
interventionists, the PI and investigators from the NGH, UCD, 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 Officer (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.  

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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 NGH RCT 
leads (i.e., Dr. Ngoc and Dr. Hung) within 48 hours. Upon receiving the report, 
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, 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 
case 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 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 (please see Section 16).  
 
13) Potential Benefits to Subjects 
There are several potential direct benefits to subjects. Caregivers 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 

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having information about their cognitive testing be provided to their primary care 
physician.  
14) Multi-Site Research 
 
This is a single-site, multiple PIs, 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 
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 
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. Interventionists 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.  
 
Inconvenience due to questionnaires: Some of the survey questions might make 
participants feel uncomfortable or upset. 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 

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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. 
 
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. 
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. 

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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. 
 
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.