Dementia AlzheimersNCT03100617
Alzheimer's Family Caregiver Intervention in Vietnam
A study testing Psychosocial caregiver intervention in people with Dementia Alzheimers, run by University of California, Davis at 1 site in Vietnam.
Trial summary
This is a single arm pilot study of 6-8 families to test the feasibility and acceptability of a Alzheimer's family caregiver intervention in Vietnam. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Dementia Alzheimers
- What is being tested?
- Psychosocial caregiver intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteVietnam
- Study dates
- 26 Aug 2017to 18 Jun 2018
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary adult family caregiver of person with dementia
Who cannot join
- Caregivers of persons with dementia who are institutionalized
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Arm Study of Modified REACH-VA Alzheimer's Caregiver Intervention in Vietnam
This is a single arm pilot study of 6-8 families to test the feasibility and acceptability of a Alzheimer's family caregiver intervention in Vietnam.
Read the detailed description
This is a single arm pilot study of 6-8 families to test the feasibility and acceptability of a modified version of the REACH-VA caregiver intervention in Vietnam. The REACH-VA caregiver intervention is an evidence-based intervention that has been shown to be effective in multicultural populations in the US. The model has been modified for use in Vietnam. This study will test the modified model in Vietnam. Participants in this study will be adult family caregivers of non-institutionalized persons with dementia who are living in Hanoi, Vietnam. They will receive 4-6 sessions delivered over the course of 2-3 months that will included the following components: 1) education about the nature of the disease, 2) risk assessment, 3) enhancing caregiver skills and problem-solving, and 4) caregiver stress reduction. The intervention will be delivered by a social worker or nurse using a Vietnamese language versions of the REACH-VA protocol and caregiver intervention notebook.
- Conditions
- Dementia Alzheimers
- Being tested
- Psychosocial caregiver intervention
- Keywords
- Family caregiver
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychosocial caregiver interventionBehavioural
Modified version of the REACH-VA intervention for family caregivers of persons with dementia. The intervention has several components including 1) caregiver education, 2) risk assessment, 3) caregiver needs assessment, 4) caregiver skill building and problem solving, and 4) caregiver stress reduction.
| Study group | Role | What they receive |
|---|---|---|
| REACH-VA family caregiver intervention | Experimental | Behavioral intervention with several components including 1) caregiver education, 2) risk assessment, 3) caregiver needs assessment, 4) caregiver skill building and problem solving, and 4) caregiver stress reduction. Receives: Behavioral: Psychosocial caregiver intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caregiver Burden
Zarit Burden scale
Measured: Change from baseline Zarit burden scale score to 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start26 Aug 2017
- Primary completion18 Jun 2018
- Study completion18 Jun 2018
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 Dementia AlzheimersStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- University of South Carolina
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03100617
- Sponsor's protocol ID
- 1084736
- Status last verified
- Aug 2020
- First submitted
- 24 Mar 2017
- Last updated
- 2 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Arm Study of Modified REACH-VA Alzheimer's Caregiver Intervention in Vietnam
- ClinicalTrials.gov ID
- NCT03100617
- Acronym / sponsor ID
- 1084736
- Conditions
- Dementia Alzheimers
- Keywords
- Family caregiver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- University of South Carolina
- Study start
- 26 Aug 2017 (actual)
- Primary completion
- 18 Jun 2018 (actual)
- Study completion
- 18 Jun 2018 (actual)
- First posted
- 4 Apr 2017 (actual)
- Results
- Posted 16 Mar 2020
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 single arm pilot study of 6-8 families to test the feasibility and acceptability of a Alzheimer's family caregiver intervention in Vietnam.
Detailed description
This is a single arm pilot study of 6-8 families to test the feasibility and acceptability of a modified version of the REACH-VA caregiver intervention in Vietnam. The REACH-VA caregiver intervention is an evidence-based intervention that has been shown to be effective in multicultural populations in the US. The model has been modified for use in Vietnam. This study will test the modified model in Vietnam. Participants in this study will be adult family caregivers of non-institutionalized persons with dementia who are living in Hanoi, Vietnam. They will receive 4-6 sessions delivered over the course of 2-3 months that will included the following components: 1) education about the nature of the disease, 2) risk assessment, 3) enhancing caregiver skills and problem-solving, and 4) caregiver stress reduction. The intervention will be delivered by a social worker or nurse using a Vietnamese language versions of the REACH-VA protocol and caregiver intervention notebook.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| REACH-VA family caregiver intervention | Experimental | Behavioral: Psychosocial caregiver interventionBehavioral intervention with several components including 1) caregiver education, 2) risk assessment, 3) caregiver needs assessment, 4) caregiver skill building and problem solving, and 4) caregiver stress reduction. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Primary adult family caregiver of person with dementia
Key exclusion criteria (1 listed)
- Caregivers of persons with dementia who are institutionalized
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 |
|---|---|---|
| Psychosocial caregiver interventionModified version of the REACH-VA intervention for family caregivers of persons with dementia. The intervention has several components including 1) caregiver education, 2) risk assessment, 3) caregiver needs assessment, 4) caregiver skill building and problem solving, and 4) caregiver stress reduction. | Behavioural | REACH-VA family caregiver intervention |
Primary outcome
Caregiver Burden
Time frame: Change from baseline Zarit burden scale score to 3 months.
Zarit Burden scale
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
- 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 Psychosocial caregiver intervention in people with Dementia Alzheimers, 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 1 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 2 Sep 2020. 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. 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 16 Mar 2020). 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?
Caregiver Burden (time frame: Change from baseline Zarit burden scale score to 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 2 Sep 2020; AzTrials last refreshed its copy on 8 Nov 2026.