Single Arm Study of Modified REACH-VA Alzheimer's Caregiver Intervention in Vietnam
Phase: NA
Conditions: Dementia Alzheimers
Sponsor: University of California, Davis

PROTOCOL TITLE: Case series to pilot a psychosocial intervention to support 
Alzheimer’s family caregivers in Vietnam 
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Revised: February 27, 2017 
 
1) Protocol Title 
Title:  Case series to pilot a psychosocial intervention to support Alzheimer’s 
family caregivers in Vietnam 
Protocol Version Date: 6/5/2017 
2) Objectives 
The objective of this study is to pilot test a behavioral intervention for family 
caregivers of persons with Alzheimer’s disease in Vietnam in order to determine 
its feasibility and acceptability.  Based on the results of this study, the behavioral 
intervention will be modified and then tested in a future randomized controlled 
trial. 
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 
building capacity of investigators in Vietnam to pilot-test REACH-VA, an 
evidence-based model for dementia caregiver support.   This project also builds 
on preliminary data based on interviews with key stakeholders in Vietnam, 
including family caregivers of persons with dementia as well as community 
leaders, which leads the research team to conclude that the REACH-VA is 
appropriate for the Vietnamese context. 
 
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. 
To be eligible, the person will 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 
Alhzeimer’s disease or another degenerative dementia. All participants will be 
living in the Soc Son area outside Hanoi, Vietnam.  

PROTOCOL TITLE: Case series to pilot a psychosocial intervention to support 
Alzheimer’s family caregivers in Vietnam 
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Revised: February 27, 2017 
The final sample will be 10 family caregivers of persons dignosed with dementia. 
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 3-6 sessions delivered over the 
course of 2-3 months. 
• We anticipate enrolling subjects from mid-July through the end of September, 
2017 
• We anticipate completing preliminary analsysis of the data by January of 
2018. 
6) Study Endpoints 
This is a time-limited intervention lasting up to 2-3 months.   
7) Procedures Involved 
This is case series to pilot-test a culturally adapated behavioral intervention to 
support Alzheimer’s family caregivers. The manualized intervention will consist 
of 3-6 one hour sessions with a trained health professional (e.g. nurse or social 
worker).  The sessions will be administered in the home (or other setting of the 
subject’s choice such as a clinic) and focus on psychoeducation, stress reduction, 
skill-building. The intervention will be tailored to the needs and preferences of the 
caregiver. 
A research protocol will be used that includes scripts, study scales (e.g. 
depression, anxiety) detailed desciptions of the goals for each session, and 
standardized forms (see attached study manual). 
8) Data and/or Specimen Management and Confidentiality 
Because the main goal of the study is to pilot-test the intervention in a small 
number of subjects prior to a larger randomized controlled trial, there are no 
planned statistical analyses. 
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. 

PROTOCOL TITLE: Case series to pilot a psychosocial intervention to support 
Alzheimer’s family caregivers in Vietnam 
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Revised: February 27, 2017 
NIH onlinecourse) – 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. At the conclusion of 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 pilot care series is to assess feasibility and acceptability 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 UofSC.  The caregiver’s 
level of distress and any indicators of elder abuse/neglect will be reviewed at each 
session. All adverse events to the PIs from all three institutions within 24 hours.  
 
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 
 
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-

PROTOCOL TITLE: Case series to pilot a psychosocial intervention to support 
Alzheimer’s family caregivers in Vietnam 
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Revised: February 27, 2017 
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 a 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 as a result of the intervention.  In addition, 
caregivers will learn stress reduction techniques that may help reduce caregiving-
related distress.   
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. 

PROTOCOL TITLE: Case series to pilot a psychosocial intervention to support 
Alzheimer’s family caregivers in Vietnam 
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Revised: February 27, 2017 
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. 
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. 

PROTOCOL TITLE: Case series to pilot a psychosocial intervention to support 
Alzheimer’s family caregivers in Vietnam 
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Revised: February 27, 2017 
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.