An interventional study of REACH VN and Enhanced control in Dementia, sponsored by University of California, Davis. Completed at 1 site in Vietnam. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-24.
Sponsored by University of California, Davis · Not applicable, Interventional, and Supportive care
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.
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.
2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.
This study's enrollment of 350 is above the median of 83 across 1,629 interventional studies indexed under Dementia.
Browse Dementia studies →University of California, Davis is the lead sponsor of 798 studies on the registry; 146 are open to participants now.
Of its 65 completed or terminated interventional studies of FDA-regulated products, 43 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: REACH VN
A single session focused on education about the nature of dementia.
Behavioral: Enhanced control
4-6 sessions delivered over the course of 2-3 months.
A single session providing education about dementia
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.
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)
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.
Time frame: Baseline period at month 0, follow up period at 3 months, and follow up period at 6 months
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.
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)
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.
Time frame: Baseline period at month 0, follow up period at 3 months, and follow up period at 6 months
| Milestone | REACH VN | Enhanced Control |
|---|---|---|
| Started | 175 | 175 |
| Completed | 148 | 157 |
| Not completed | 27 | 18 |
| Withdrew: Care recipients passed away | 18 | 13 |
| Withdrew: No longer a primary caregiver | 5 | 1 |
| Withdrew: Withdrawal by subject | 4 | 2 |
| Withdrew: Caregivers passed away | 0 | 2 |
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.
| score on a scale | REACH VN | Enhanced Control |
|---|---|---|
| Baseline | 21.4 ± 8.4 | 22.0 ± 6.8 |
| 3 months | 20.1 ± 8.8 | 22.3 ± 8.8 |
| 6 months | 19.2 ± 9.1 | 22.4 ± 8.6 |
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.
| score on a scale | REACH VN | Enhanced Control |
|---|---|---|
| Baseline | 3.7 ± 3.4 | 3.8 ± 3.6 |
| 3 months | 2.9 ± 3.0 | 4.4 ± 3.7 |
| 6 months | 3.4 ± 3.3 | 3.8 ± 3.2 |
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.
| score on a scale | REACH VN | Enhanced Control |
|---|---|---|
| Baseline | 13.7 ± 6.8 | 14.1 ± 6.7 |
| 3 months | 11.9 ± 6.9 | 14.1 ± 6.7 |
| 6 months | 12.7 ± 7.2 | 13.7 ± 6.8 |
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.
| score on a scale | REACH VN | Enhanced Control |
|---|---|---|
| Baseline | 9.0 ± 5.4 | 9.0 ± 5.2 |
| 3 months | 7.6 ± 4.5 | 9.5 ± 5.7 |
| 6 months | 8.2 ± 5.1 | 8.8 ± 5.1 |
Collected over For each participant, adverse events were collected for the duration of participation in the study (up to 6 months). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| REACH VN | 0/175 (0%) | 0/175 (0%) | 0/175 (0%) |
| Enhanced Control | 2/175 (1.1%) | 0/175 (0%) | 0/175 (0%) |
Baseline characteristics are reported only for participants who completed the 3-month follow-up. Participants who dropped out before the 3-month follow-up are not included in the baseline analysis.
| Age, Continuous(years) | REACH VN | Enhanced Control | Total |
|---|---|---|---|
| Mean | 61.9 ± 10.9 | 61.4 ± 11.3 | 61.7 ± 11.1 |
| Sex: Female, Male(Participants) | REACH VN | Enhanced Control | Total |
|---|---|---|---|
| Female | 116 | 117 | 233 |
| Male | 44 | 53 | 97 |
| Ethnicity (NIH/OMB)(Participants) | REACH VN | Enhanced Control | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 160 | 170 | 330 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | REACH VN | Enhanced Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 160 | 170 | 330 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Zarit Burden Interview-12 (ZBI-12)(score on a scale) | REACH VN | Enhanced Control | Total |
|---|---|---|---|
| Mean | 21.4 ± 8.4 | 22.0 ± 8.6 | 21.7 ± 8.5 |
| Patient Health Questionnaire-4 (PHQ-4)(score on a scale) | REACH VN | Enhanced Control | Total |
|---|---|---|---|
| Mean | 3.7 ± 3.4 | 3.8 ± 3.6 | 3.7 ± 3.5 |
| Perceived Stress Scale (PSS-10)(score on a scale) | REACH VN | Enhanced Control | Total |
|---|---|---|---|
| Mean | 13.7 ± 6.8 | 14.1 ± 6.7 | 13.9 ± 6.75 |
| Patient Health Questionnaire-15 (PHQ-15)(score on a scale) | REACH VN | Enhanced Control | Total |
|---|---|---|---|
| Mean | 9.0 ± 5.4 | 9.0 ± 5.2 | 9.0 ± 5.3 |
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University of California, Davis