DementiaNCT04542317
Efficacy of a Dementia Family Caregiver Support Intervention in Vietnam
A study testing REACH VN in people with Dementia, run by University of California, Davis at 1 site in Vietnam.
Trial summary
This is a cluster randomized controlled trial to test the efficacy of a psychosocial intervention to support family caregivers of persons living with dementia in Vietnam. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- REACH VN
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- 1 siteVietnam
- Study dates
- 15 Oct 2020to 27 Feb 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 is not available to participate, an alternate family member who provides substantial care (i.e., at least 4 hours/day) 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.
Who cannot join
- Significant cognitive impairment or sensory deficit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cluster Randomized Controlled Trial to Test the Efficacy of a Psychosocial Intervention (REACH VN) to Support Alzheimer's Family Caregivers in Vietnam
This is a cluster randomized controlled trial to test the efficacy of a psychosocial intervention to support family caregivers of persons living with dementia in Vietnam.
Read the detailed description
The objective of this study is to conduct a cluster randomized controlled trial (RCT) 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 the 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.
- Conditions
- Dementia
- Being tested
- REACH VN, Enhanced control
- Keywords
- Family caregiving
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REACH VNBehavioural
4-6 sessions delivered over the course of 2-3 months.
Enhanced controlBehavioural
A single session providing education about dementia
| Study group | Role | What they receive |
|---|---|---|
| REACH VN | Experimental | A multi-component behavioral intervention to support family caregivers of persons with dementia. Participants will receive 4-6 sessions in-person or by phone over the course of 2-3 months. Receives: Behavioral: REACH VN |
| Enhanced control | Placebo comparator | A single session focused on education about the nature of dementia. Receives: Behavioral: Enhanced control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Zarit Burden Interview-12 (ZBI-12)
The Zarit Burden Interview-12 (ZBI-12) asked caregivers to rate on a scale of 0 (never) to 4 (nearly always) how often they have experienced feelings of burden or stress related to caregiving (total score range: 0-48). A higher score indicates a higher feel of burden.
Measured: Baseline period at month 0, follow up period at 3 months, and follow up period at 6 months
Patient Health Questionnaire-4 (PHQ-4)
Patient Health Questionnaire-4 (PHQ-4) asked caregivers to rate on a scale of 0 (not at all) to 3 (nearly every day) how often they have been bothered by symptoms (e.g., feeling nervous, anxious, or on edge) over the past two weeks (total score range: 0-12). A higher score indicates a higher severity.
Measured: Baseline period at month 0, follow up period at 3 months, and follow up period at 6 months
Secondary outcomes (2)
Perceived Stress Scale (PSS-10)
In the Perceived Stress Scale-10 (PSS-10), caregivers were asked to rate on a scale of 0 (never) to 4 (very often) how often they have felt a certain way (e.g., been upset because of something that happened unexpectedly) within the past month (total score range: 0-40). A higher sore indicates a higher perceived stress.
Measured: Baseline period at month 0, follow up period at 3 months, and follow up period at 6 months
Patient Health Questionnaire-15 (PHQ-15)
In the Patient Health Questionnaire-15 (PHQ-15), caregivers were asked to rate on a 3-point scale (0 = not bothered at all, 1 = bothered a little, 2 = bothered a lot) how much they have been bothered by somatic symptoms (e.g., stomach pain, headaches) during the past seven days (total score range: 0-30). A higher score indicates a greater severity.
Measured: Baseline period at month 0, follow up period at 3 months, and follow up period at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start15 Oct 2020
- Primary completion27 Feb 2024
- Study completion27 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The active treatment is REACH VN, a culturally adapted version of REACH VA, a multi-component dementia family caregiver support intervention that includes psychoeducation, stress reduction, problem-solving, and skill-building.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- National Geriatric Hospital, University of Minnesota, National Institute on Aging (NIA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04542317
- Sponsor's protocol ID
- 1574137
- Other IDs
- R01AG064688, TR001860
- Status last verified
- Mar 2025
- First submitted
- 31 Aug 2020
- Last updated
- 24 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nguyen H, Nguyen HT, Nguyen NB, Tran D, Harvey DJ, Nguyen BT, Nguyen BTT, Nguyen AN, Nguyen CTH, Nguyen TTH, Nguyen TL, Nguyen ATP, Nguyen NH, Nguyen AL, Luong YH, Nguyen BH, Nguyen PQ, Gitlin LN, Nguyen TA, Pham T, Hinton L. Testing the Efficacy of a Culturally Adapted Family Dementia Caregiver Intervention (REACH VN): Results From a Cluster Randomized Controlled Trial in Northern Vietnam. Am J Geriatr Psychiatry. 2025 May;33(5):535-545. doi: 10.1016/j.jagp.2024.10.011. Epub 2024 Oct 23.
PubMed 39547823Tran D, Nguyen H, Pham T, Nguyen AT, Nguyen HT, Nguyen NB, Nguyen BH, Harvey D, Gitlin L, Hinton L. Resources for Enhancing Alzheimer's Caregiver Health in Vietnam (REACH VN): study protocol for a cluster randomized controlled trial to test the efficacy of a family dementia caregiver intervention in Vietnam. Trials. 2022 May 9;23(1):377. doi: 10.1186/s13063-022-06228-6.
PubMed 35534904
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cluster Randomized Controlled Trial to Test the Efficacy of a Psychosocial Intervention (REACH VN) to Support Alzheimer's Family Caregivers in Vietnam
- ClinicalTrials.gov ID
- NCT04542317
- Acronym / sponsor ID
- 1574137
- Conditions
- Dementia
- Keywords
- Family caregiving
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- National Geriatric Hospital, University of Minnesota, National Institute on Aging (NIA)
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 27 Feb 2024 (actual)
- Study completion
- 27 Feb 2024 (actual)
- First posted
- 9 Sep 2020 (actual)
- Results
- Posted 24 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a cluster randomized controlled trial to test the efficacy of a psychosocial intervention to support family caregivers of persons living with dementia in Vietnam.
Detailed description
The objective of this study is to conduct a cluster randomized controlled trial (RCT) 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 the 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The active treatment is REACH VN, a culturally adapted version of REACH VA, a multi-component dementia family caregiver support intervention that includes psychoeducation, stress reduction, problem-solving, and skill-building.
| Arm | Type | Receives |
|---|---|---|
| REACH VN | Experimental | Behavioral: REACH VNA multi-component behavioral intervention to support family caregivers of persons with dementia. Participants will receive 4-6 sessions in-person or by phone over the course of 2-3 months. |
| Enhanced control | Placebo comparator | Behavioral: Enhanced controlA single session focused on education about the nature of dementia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 is not available to participate, an alternate family member who provides substantial care (i.e., at least 4 hours/day) 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.
Key exclusion criteria (1 listed)
- Significant cognitive impairment or sensory deficit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REACH VN4-6 sessions delivered over the course of 2-3 months. | Behavioural | REACH VN |
| Enhanced controlA single session providing education about dementia | Behavioural | Enhanced control |
Primary outcome
Zarit Burden Interview-12 (ZBI-12)
Time frame: Baseline period at month 0, follow up period at 3 months, and follow up period at 6 months
The Zarit Burden Interview-12 (ZBI-12) asked caregivers to rate on a scale of 0 (never) to 4 (nearly always) how often they have experienced feelings of burden or stress related to caregiving (total score range: 0-48). A higher score indicates a higher feel of burden.
Patient Health Questionnaire-4 (PHQ-4)
Time frame: Baseline period at month 0, follow up period at 3 months, and follow up period at 6 months
Patient Health Questionnaire-4 (PHQ-4) asked caregivers to rate on a scale of 0 (not at all) to 3 (nearly every day) how often they have been bothered by symptoms (e.g., feeling nervous, anxious, or on edge) over the past two weeks (total score range: 0-12). A higher score indicates a higher severity.
2 secondary outcomes
Perceived Stress Scale (PSS-10)
Time frame: Baseline period at month 0, follow up period at 3 months, and follow up period at 6 months
Patient Health Questionnaire-15 (PHQ-15)
Time frame: Baseline period at month 0, follow up period at 3 months, and follow up period at 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39547823Nguyen H, Nguyen HT, Nguyen NB, Tran D, Harvey DJ, Nguyen BT, Nguyen BTT, Nguyen AN, Nguyen CTH, Nguyen TTH, Nguyen TL, Nguyen ATP, Nguyen NH, Nguyen AL, Luong YH, Nguyen BH, Nguyen PQ, Gitlin LN, Nguyen TA, Pham T, Hinton L. Testing the Efficacy of a Culturally Adapted Family Dementia Caregiver Intervention (REACH VN): Results From a Cluster Randomized Controlled Trial in Northern Vietnam. Am J Geriatr Psychiatry. 2025 May;33(5):535-545. doi: 10.1016/j.jagp.2024.10.011. Epub 2024 Oct 23.
- Derived from this study: PubMed 35534904Tran D, Nguyen H, Pham T, Nguyen AT, Nguyen HT, Nguyen NB, Nguyen BH, Harvey D, Gitlin L, Hinton L. Resources for Enhancing Alzheimer's Caregiver Health in Vietnam (REACH VN): study protocol for a cluster randomized controlled trial to test the efficacy of a family dementia caregiver intervention in Vietnam. Trials. 2022 May 9;23(1):377. doi: 10.1186/s13063-022-06228-6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REACH VN in people with Dementia, run by University of California, Davis at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Zarit Burden Interview-12 (ZBI-12) (time frame: Baseline period at month 0, follow up period at 3 months, and follow up period at 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04542317, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.