DementiaNCT05481320
A Phone Intervention for Family Dementia Caregivers in Vietnam
A study testing REACH VN Phone Intervention 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 examine the feasibility, acceptability, and preliminary efficacy of the phone version of REACH VN, a psychosocial culturally adapted Alzheimer's family caregiving 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 Phone Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteVietnam
- Study dates
- 27 Oct 2022to 28 Aug 2023
- 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 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. Clusters will have a minimum of 3 participants and a maximum of 15 participants.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
This is a cluster randomized controlled trial to examine the feasibility, acceptability, and preliminary efficacy of the phone version of REACH VN, a psychosocial culturally adapted Alzheimer's family caregiving 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 examine the feasibility, acceptability, and preliminary efficacy of the phone version of REACH VN (Resources for Enhancing Alzheimer's Caregiver Health in Vietnam), 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.
- Conditions
- Dementia
- Being tested
- REACH VN Phone Intervention, Enhanced Control
- Keywords
- dementia, family caregiving, phone intervention, non-pharmacological intervention, dementia caregivers
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REACH VN Phone InterventionBehavioural
4-6 intervention sessions delivered via phone over the course of 1-3 months.
Enhanced ControlBehavioural
A single phone session providing education about dementia.
| Study group | Role | What they receive |
|---|---|---|
| REACH VN Phone Intervention | Experimental | A multicomponent behavioral intervention to support family caregivers of persons with dementia. The enrollment session (session 0) will be conducted face-to-face. Thereafter, participants will receive 4-6 intervention sessions by 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. Receives: Behavioral: REACH VN Phone Intervention |
| Enhanced control | Placebo comparator | A single phone 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-6 (ZBI-6)
Change in caregiver burden related to caregiving. Range is 0-24. A higher score indicates a higher burden.
Measured: Baseline, 3 months
Secondary outcomes (1)
Patient Health Questionnaire-4 (PHQ-4)
Change in caregiver psychological distress (e.g., depressive and anxiety symptoms). Range is 0-12. A higher score indicates a greater level of psychological distress.
Measured: Baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start27 Oct 2022
- Primary completion28 Aug 2023
- Study completion28 Aug 2023
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.
- 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 a REACH VN phone intervention, a culturally adapted version of REACH VA, a multicomponent dementia family caregiver support intervention that includes psychoeducation, stress reduction, problem-solving, and skill-building.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- University of Minnesota, National Geriatric Hospital, National Institute on Aging (NIA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05481320
- Sponsor's protocol ID
- 1937464
- Other IDs
- R01AG064688
- Status last verified
- Dec 2024
- First submitted
- 28 Jul 2022
- Last updated
- 11 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phone Intervention for Family Dementia Caregivers in Vietnam
- ClinicalTrials.gov ID
- NCT05481320
- Acronym / sponsor ID
- 1937464
- Conditions
- Dementia
- Keywords
- dementia, family caregiving, phone intervention, non-pharmacological intervention, dementia caregivers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- University of Minnesota, National Geriatric Hospital, National Institute on Aging (NIA)
- Study start
- 27 Oct 2022 (actual)
- Primary completion
- 28 Aug 2023 (actual)
- Study completion
- 28 Aug 2023 (actual)
- First posted
- 1 Aug 2022 (actual)
- Results
- Posted 11 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 examine the feasibility, acceptability, and preliminary efficacy of the phone version of REACH VN, a psychosocial culturally adapted Alzheimer's family caregiving 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 examine the feasibility, acceptability, and preliminary efficacy of the phone version of REACH VN (Resources for Enhancing Alzheimer's Caregiver Health in Vietnam), 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.
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 a REACH VN phone intervention, a culturally adapted version of REACH VA, a multicomponent dementia family caregiver support intervention that includes psychoeducation, stress reduction, problem-solving, and skill-building.
| Arm | Type | Receives |
|---|---|---|
| REACH VN Phone Intervention | Experimental | Behavioral: REACH VN Phone InterventionA multicomponent behavioral intervention to support family caregivers of persons with dementia. The enrollment session (session 0) will be conducted face-to-face. Thereafter, participants will receive 4-6 intervention sessions by 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. |
| Enhanced control | Placebo comparator | Behavioral: Enhanced ControlA single phone 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 (3 listed)
- 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. Clusters will have a minimum of 3 participants and a maximum of 15 participants.
Key exclusion criteria (4 listed)
- 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
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 VN Phone Intervention4-6 intervention sessions delivered via phone over the course of 1-3 months. | Behavioural | REACH VN Phone Intervention |
| Enhanced ControlA single phone session providing education about dementia. | Behavioural | Enhanced control |
Primary outcome
Zarit Burden Interview-6 (ZBI-6)
Time frame: Baseline, 3 months
Change in caregiver burden related to caregiving. Range is 0-24. A higher score indicates a higher burden.
1 secondary outcome
Patient Health Questionnaire-4 (PHQ-4)
Time frame: Baseline, 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 Phone Intervention 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 3 inclusion and 4 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 11 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 11 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-6 (ZBI-6) (time frame: Baseline, 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Mar 2025.