Trial Outcomes & Findings for Efficacy of a Dementia Family Caregiver Support Intervention in Vietnam (NCT NCT04542317)
NCT ID: NCT04542317
Last Updated: 2025-03-24
Results Overview
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.
COMPLETED
NA
350 participants
Baseline period at month 0, follow up period at 3 months, and follow up period at 6 months
2025-03-24
Participant Flow
41 clusters were randomized. 20 clusters were allocated to enhanced control, and 21 clusters were allocated to REACH VN intervention. 306 caregivers in enhanced control arm and 354 caregivers in REACH VN arm were assess for eligibility. During the subsequent screening process, we excluded one control cluster because the number of enrolled caregivers was below the threshold of five, leaving 40 enrolled clusters at the start of the study (21 intervention and 19 enhanced control).
Unit of analysis: cluster
Participant milestones
| Measure |
REACH VN
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.
|
Enhanced Control
A single session focused on education about the nature of dementia.
|
|---|---|---|
|
Overall Study
STARTED
|
175 21
|
175 19
|
|
Overall Study
COMPLETED
|
148 21
|
157 19
|
|
Overall Study
NOT COMPLETED
|
27 0
|
18 0
|
Reasons for withdrawal
| Measure |
REACH VN
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.
|
Enhanced Control
A single session focused on education about the nature of dementia.
|
|---|---|---|
|
Overall Study
Care recipients passed away
|
18
|
13
|
|
Overall Study
No longer a primary caregiver
|
5
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
|
Overall Study
Caregivers passed away
|
0
|
2
|
Baseline Characteristics
Efficacy of a Dementia Family Caregiver Support Intervention in Vietnam
Baseline characteristics by cohort
| Measure |
REACH VN
n=160 Participants
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.
|
Enhanced Control
n=170 Participants
A single session focused on education about the nature of dementia.
|
Total
n=330 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
116 Participants
n=5 Participants
|
117 Participants
n=7 Participants
|
233 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Age, Continuous
|
61.9 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
61.4 years
STANDARD_DEVIATION 11.3 • n=7 Participants
|
61.7 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
160 Participants
n=5 Participants
|
170 Participants
n=7 Participants
|
330 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
160 Participants
n=5 Participants
|
170 Participants
n=7 Participants
|
330 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Zarit Burden Interview-12 (ZBI-12)
|
21.4 score on a scale
STANDARD_DEVIATION 8.4 • n=5 Participants
|
22.0 score on a scale
STANDARD_DEVIATION 8.6 • n=7 Participants
|
21.7 score on a scale
STANDARD_DEVIATION 8.5 • n=5 Participants
|
|
Patient Health Questionnaire-4 (PHQ-4)
|
3.7 score on a scale
STANDARD_DEVIATION 3.4 • n=5 Participants
|
3.8 score on a scale
STANDARD_DEVIATION 3.6 • n=7 Participants
|
3.7 score on a scale
STANDARD_DEVIATION 3.5 • n=5 Participants
|
|
Perceived Stress Scale (PSS-10)
|
13.7 score on a scale
STANDARD_DEVIATION 6.8 • n=5 Participants
|
14.1 score on a scale
STANDARD_DEVIATION 6.7 • n=7 Participants
|
13.9 score on a scale
STANDARD_DEVIATION 6.75 • n=5 Participants
|
|
Patient Health Questionnaire-15 (PHQ-15)
|
9.0 score on a scale
STANDARD_DEVIATION 5.4 • n=5 Participants
|
9.0 score on a scale
STANDARD_DEVIATION 5.2 • n=7 Participants
|
9.0 score on a scale
STANDARD_DEVIATION 5.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline period at month 0, follow up period at 3 months, and follow up period at 6 monthsPopulation: The analytic sample included participants who completed at least 3-month assessment.
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.
Outcome measures
| Measure |
REACH VN
n=160 Participants
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.
|
Enhanced Control
n=170 Participants
A single session focused on education about the nature of dementia.
|
|---|---|---|
|
Zarit Burden Interview-12 (ZBI-12)
Baseline
|
21.4 score on a scale
Standard Deviation 8.4
|
22.0 score on a scale
Standard Deviation 6.8
|
|
Zarit Burden Interview-12 (ZBI-12)
3 months
|
20.1 score on a scale
Standard Deviation 8.8
|
22.3 score on a scale
Standard Deviation 8.8
|
|
Zarit Burden Interview-12 (ZBI-12)
6 months
|
19.2 score on a scale
Standard Deviation 9.1
|
22.4 score on a scale
Standard Deviation 8.6
|
PRIMARY outcome
Timeframe: Baseline period at month 0, follow up period at 3 months, and follow up period at 6 monthsPopulation: The analytic sample included participants who completed at least 3-month assessment.
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.
Outcome measures
| Measure |
REACH VN
n=160 Participants
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.
|
Enhanced Control
n=170 Participants
A single session focused on education about the nature of dementia.
|
|---|---|---|
|
Patient Health Questionnaire-4 (PHQ-4)
Baseline
|
3.7 score on a scale
Standard Deviation 3.4
|
3.8 score on a scale
Standard Deviation 3.6
|
|
Patient Health Questionnaire-4 (PHQ-4)
3 months
|
2.9 score on a scale
Standard Deviation 3.0
|
4.4 score on a scale
Standard Deviation 3.7
|
|
Patient Health Questionnaire-4 (PHQ-4)
6 months
|
3.4 score on a scale
Standard Deviation 3.3
|
3.8 score on a scale
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: Baseline period at month 0, follow up period at 3 months, and follow up period at 6 monthsPopulation: The analytic sample included participants who completed at least 3-month assessment.
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.
Outcome measures
| Measure |
REACH VN
n=160 Participants
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.
|
Enhanced Control
n=170 Participants
A single session focused on education about the nature of dementia.
|
|---|---|---|
|
Perceived Stress Scale (PSS-10)
3 months
|
11.9 score on a scale
Standard Deviation 6.9
|
14.1 score on a scale
Standard Deviation 6.7
|
|
Perceived Stress Scale (PSS-10)
6 months
|
12.7 score on a scale
Standard Deviation 7.2
|
13.7 score on a scale
Standard Deviation 6.8
|
|
Perceived Stress Scale (PSS-10)
Baseline
|
13.7 score on a scale
Standard Deviation 6.8
|
14.1 score on a scale
Standard Deviation 6.7
|
SECONDARY outcome
Timeframe: Baseline period at month 0, follow up period at 3 months, and follow up period at 6 monthsPopulation: The analytic sample included participants who completed at least 3-month assessment.
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.
Outcome measures
| Measure |
REACH VN
n=160 Participants
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.
|
Enhanced Control
n=170 Participants
A single session focused on education about the nature of dementia.
|
|---|---|---|
|
Patient Health Questionnaire-15 (PHQ-15)
Baseline
|
9.0 score on a scale
Standard Deviation 5.4
|
9.0 score on a scale
Standard Deviation 5.2
|
|
Patient Health Questionnaire-15 (PHQ-15)
3 months
|
7.6 score on a scale
Standard Deviation 4.5
|
9.5 score on a scale
Standard Deviation 5.7
|
|
Patient Health Questionnaire-15 (PHQ-15)
6 months
|
8.2 score on a scale
Standard Deviation 5.1
|
8.8 score on a scale
Standard Deviation 5.1
|
Adverse Events
REACH VN
Enhanced Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place