Cluster Randomized Controlled Trial to Test the Feasibility, Acceptability and Preliminary Effectiveness of a Psychosocial Intervention to Support Alzheimer's Family Caregivers in Vietnam
Phase: NA
Conditions: Family Caregivers
Sponsor: University of California, Davis

Study Title: Randomized controlled trial to test the feasibility, 
acceptability, and preliminary effectiveness of a psychosocial intervention 
to support Alzheimer’s family caregivers in Vietnam.
NCT#: NCT03587974
Document Date: April 2, 2018
Document Type: Study Protocol

PROTOCOL TITLE: Randomized controlled trial to test the feasibility, acceptability, and 
preliminary effectiveness of a psychosocial intervention to support Alzheimer’s family
caregivers in Vietnam 
Page 1 of 8
Revised: February 27, 2017
1) Protocol Title
Title:  Randomized controlled trial to test the feasibility, acceptability and 
preliminary effectiveness of a psychosocial intervention to support Alzheimer’s
family caregivers in Vietnam 
Protocol Version Date: 4/2/2018 
2) Objectives
The objective of this study is to conduct a randomized controlled trial to test the 
preliminary effectiveness, feasibility and acceptability of a psychosocial 
intervention to support Alzheimer’s family caregivers in Vietnam.  In terms of 
preliminary effectiveness, our hypothesis is that caregivers in the intervention will 
show lower psychological distress and lower caregiver burden 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, 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 two preliminary studies, including interviews with key 
stakeholder and a case series.  These preliminary studies demonstrated the 
acceptability of the intervention model but also identified areas for modification 
to tailor the intervention to the social, economic, and cultural circumstances in 
Vietnam.  
4) Inclusion and Exclusion Criteria
Alzheimer’s family caregivers will be identified through a registry of persons
with dementia at the Vietnam National Geriatric Hospital in Hanoi. 

PROTOCOL TITLE: Randomized controlled trial to test the feasibility, acceptability, and 
preliminary effectiveness of a psychosocial intervention to support Alzheimer’s family 
caregivers in Vietnam 
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Revised: February 27, 2017 
To be eligible, the person will be an adult who is the identified primary adult 
caregiver (i.e. the person spending the most time day-to-day providing care) to an 
older adult who is living in the community and has received a diagnosis of 
Alzheimer’s disease or another degenerative dementia. All participants will be 
living in the Soc Son area outside Hanoi, Vietnam.  
The final sample will be 50 family caregivers of persons diagnosed with dementia 
(25 in the active intervention and 25 in the control group). The study will exclude 
• Adults unable to consent 
• Individuals who are not yet adults (infants, children, teenagers) 
• Prisoners 
• Pregnant women. 
5) Study Timelines 
• Each family caregiver will participate in the study for 3 months.   
• We will enroll subjects from April 1 through the end of September, 2018. 
• We will complete preliminary analysis of the data by the end of January of 
2019. 
6) Study Endpoints 
This is a time-limited intervention lasting up to 3 months.   
7) Procedures Involved 
This is cluster randomized controlled trial to pilot-test a culturally adapted 
behavioral intervention to support Alzheimer’s family caregivers.  
Participants in the intervention clusters will receive a manualized intervention that 
will consist of 3-6 one-hour sessions with a trained health professional (e.g. nurse, 
social worker, or physician) who has been certified to deliver the intervention.  
The sessions will be administered in the home (or other setting of the subject’s 
choice such as a clinic) and include several components, including 
psychoeducation, stress reduction, skill-building. The intervention will be tailored 
to the needs and preferences of the caregiver. 
Participants in the control clusters will receive education about Alzheimer’s 
disease including written informational materials at the time of enrollment (i.e., 1 
session). .   
Participants in both clusters  will also be assessed at baseline and at the end of the 
intervention.   These assessments will occur at baselineand 3 months to and will 
assess primary and secondary outcomes using standardized instruments (i.e., 
items embedded in Risk Priority Intake Assessment). 
A research protocol will be used that includes scripts, study scales detailed 
descriptions of the goals for each session, and standardized forms (see attached 
study manual). 

PROTOCOL TITLE: Randomized controlled trial to test the feasibility, acceptability, and 
preliminary effectiveness of a psychosocial intervention to support Alzheimer’s family 
caregivers in Vietnam 
Page 3 of 8 
 
Revised: February 27, 2017 
 
8) Data and/or Specimen Management and Confidentiality 
The primary study outcomesare burden of caregiving (Zarit Burden Inventory) 
and caregiver distress (PHQ-4), found on pages (RP)4 and (RP)5 of the REACH 
Interventionist Notebook respectively.  Secondary outcomes include Alzheimer’s 
disease knowledge (Alzheimer’s knowledge scale)  
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) all data will 
be kept under lock and key 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 US 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 
  
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 South Carolina 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 
 
The goal of this randomized controlled trial care is to assess feasibility, 
acceptability, and preliminary effectiveness of the behavioral 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 one investigators 
from the UC Davis and the U of SC.  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) but will not have a DSMB.  The 
rationale for not having a DSMB is that this is a single-site, minimal risk clinical 
trial with a relatively small number of subjects at a single site.  The lead 
investigators (i.e. Co-PIs Hinton and Nguyen as well as the lead investigator at 
the National Geriatric Hospital, Dr. Thang) will meet quarterly with Safety 
Officer during the clinical trial.  During these meetings, the SO responsibility will 
be to review the progress of the study, 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. The SO will be a senior neurology faculty from the National Geriatric 
Hospital who is not directly involved in the study. 

PROTOCOL TITLE: Randomized controlled trial to test the feasibility, acceptability, and 
preliminary effectiveness of a psychosocial intervention to support Alzheimer’s family 
caregivers in Vietnam 
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Revised: February 27, 2017 
 
For this study, Dr. Hinton will have primary responsibility for coordinating the 
collection, review and reporting of adverse events.  Adverse events (AE) 
including serious adverse events (SAE) will be collected and reported to the IRBs 
at all three collaborating institutions on a regular basis.  At the monthly meetings 
of the research team, all incident adverse events will be graded in terms of their 
seriousness and their likely relationship to the psychosocial intervention.  All 
serious adverse events determined to have a likely relationship to the psychosocial 
intervention will be reported to the SO for this study, to the IRBs for each 
institution, and to NIA by the next business day (e.g. usually within 24 hours). 
Consistent with NIA guidelines, we will define serious adverse events as those 
that results in death, are life threatening, or places the participant at immediate 
risk of death from the event as it occurred, requires or prolongs hospitalization, 
causes persistent or significant disability or incapacity, is another condition which 
investigators judge to represent significant hazards. 
 
Cases of potential elder abuse/neglect and caregiver suicidal ideation will be 
handled according to study protocols that are consistent with local practice in 
Vietnam.  Field staff will report all suspected cases of elder abuse/neglect within 
24 hours to study investigators Dr. Hung (neurologist) and Dr. Thang (a 
geriatrician) at the National Geriatric Hospital.  After consultation with the 
research team including Drs. Hinton (a geriatric psychiatrist) and Nguyen (a 
social worker), Dr. Hung may take additional steps, including contacting and 
directly assessing the situation, educating family members about abuse, and 
referring families to local services (e.g. temples, elder clubs, social work services) 
for counseling and support.  Similarly, field staff will report to Dr. Hung any 
caregivers who express suicidal ideation.  Dr. Hung will then directly contact and 
assess the caregiver and determine if additional steps are necessary, including 
referring the caregiver for counseling, support and/or hospital-based mental health 
and social services.  Field staff, usually nurses or social workers, will be trained in 
these written protocols by the study staff (i.e. Dr. Hung and Dr. Nguyen).  All 
cases of elder abuse and caregiver suicidal ideation will be treated as adverse 
events and discussed at monthly research meetings and reported to each 
institution’s IRB.  Dr. Hinton will report serious adverse events to the SO and 
NIA.   
 
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. 
 

PROTOCOL TITLE: Randomized controlled trial to test the feasibility, acceptability, and 
preliminary effectiveness of a psychosocial intervention to support Alzheimer’s family 
caregivers in Vietnam 
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Revised: February 27, 2017 
 
12) Risks to Subjects 
 
There are two main risks associated with this study: 1) discomfort or mild distress 
because of the intervention and 2) inconvenience because of the need to fill out 
the study questionnaires. 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 are being minimized in 
several ways. First, caregiver will be given the option of discussing issues 
privately with the care manager during the intervention. Second, the care manager 
will be trained to monitor the nature of interactions between patients and family 
members and any serious issues that emerge will be discussed with the 
supervising team so that strategies can be developed to address any issues that 
arise. Finally, subjects will have the opportunity to drop out of the family-
centered arm of the study and complete treatment by themselves or drop out of the 
study altogether. 
 
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.  
This is a behavioral intervention and does not involve drug treatment.  In prior 
studies conducted in the US 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). 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.  Subject 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.   
Participants will receive $10 at the end of each study visit (including both 
intervention sessions and visits for administration of questionnaires). 

PROTOCOL TITLE: Randomized controlled trial to test the feasibility, acceptability, and 
preliminary effectiveness of a psychosocial intervention to support Alzheimer’s family 
caregivers in Vietnam 
Page 6 of 8 
 
Revised: February 27, 2017 
14) Multi-Site Research 
 
This is a single-site, multiple PI, international study and Dr. Hinton is the lead 
investigator.  Dr. Hinton will be responsible for ensuring that all sites have the 
most current version of the protocol and consent document.  He will also be 
responsible for ensuring that 1) All required approvals have been obtained at each 
site (including approval by the site’s IRB of record), 2) All modifications have 
been communicated to sites, and approved (including approval by the site’s IRB 
of record) before the modification is implemented, 3) All engaged participating 
sites will safeguard data as required by local information security policies, 4) All 
local site investigators conduct the study appropriately, and 5) 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 
 

PROTOCOL TITLE: Randomized controlled trial to test the feasibility, acceptability, and 
preliminary effectiveness of a psychosocial intervention to support Alzheimer’s family 
caregivers in Vietnam 
Page 7 of 8 
 
Revised: February 27, 2017 
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. 
 
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.  

PROTOCOL TITLE: Randomized controlled trial to test the feasibility, acceptability, and 
preliminary effectiveness of a psychosocial intervention to support Alzheimer’s family 
caregivers in Vietnam 
Page 8 of 8 
 
Revised: February 27, 2017 
 
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.