Trial Outcomes & Findings for A Phone Intervention for Family Dementia Caregivers in Vietnam (NCT NCT05481320)
NCT ID: NCT05481320
Last Updated: 2025-03-11
Results Overview
Change in caregiver burden related to caregiving. Range is 0-24. A higher score indicates a higher burden.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
Baseline, 3 months
Results posted on
2025-03-11
Participant Flow
Unit of analysis: cluster
Participant milestones
| Measure |
REACH VN Phone Intervention
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.
|
Enhanced Control
A single phone session focused on education about the nature of dementia.
|
|---|---|---|
|
Overall Study
STARTED
|
30 5
|
30 4
|
|
Overall Study
COMPLETED
|
25 5
|
27 4
|
|
Overall Study
NOT COMPLETED
|
5 0
|
3 0
|
Reasons for withdrawal
| Measure |
REACH VN Phone Intervention
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.
|
Enhanced Control
A single phone session focused on education about the nature of dementia.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Care recipent passed away
|
0
|
1
|
|
Overall Study
Out-of-window assessment
|
0
|
1
|
|
Overall Study
No longer a primary caregiver
|
3
|
0
|
|
Overall Study
Unable to contact
|
1
|
0
|
Baseline Characteristics
A Phone Intervention for Family Dementia Caregivers in Vietnam
Baseline characteristics by cohort
| Measure |
REACH VN Phone Intervention
n=25 Participants
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.
|
Enhanced Control
n=27 Participants
A single phone session focused on education about the nature of dementia.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
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
|
|
Region of Enrollment
Vietnam
|
25 participants
n=5 Participants
|
27 participants
n=7 Participants
|
52 participants
n=5 Participants
|
|
Age, Continuous
|
56.1 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
54.4 years
STANDARD_DEVIATION 11.3 • n=7 Participants
|
55.2 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
52 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
|
25 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
52 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
|
|
Zarit Burden Interview-6 (ZBI-6)
|
10.2 score on a scale
STANDARD_DEVIATION 3.7 • n=5 Participants
|
10.6 score on a scale
STANDARD_DEVIATION 5.2 • n=7 Participants
|
10.4 score on a scale
STANDARD_DEVIATION 4.5 • n=5 Participants
|
|
Patient Health Questionnaire-4 (PHQ-4)
|
4.3 score on a scale
STANDARD_DEVIATION 3.4 • n=5 Participants
|
4.8 score on a scale
STANDARD_DEVIATION 3.9 • n=7 Participants
|
4.6 score on a scale
STANDARD_DEVIATION 3.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3 monthsPopulation: The analytic sample included participants who completed 3-month assessment.
Change in caregiver burden related to caregiving. Range is 0-24. A higher score indicates a higher burden.
Outcome measures
| Measure |
REACH VN Phone Intervention
n=25 Participants
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.
|
Enhanced Control
n=27 Participants
A single phone session focused on education about the nature of dementia.
|
|---|---|---|
|
Zarit Burden Interview-6 (ZBI-6)
Baseline
|
10.2 score on a scale
Standard Deviation 3.7
|
10.6 score on a scale
Standard Deviation 5.2
|
|
Zarit Burden Interview-6 (ZBI-6)
3-month
|
8.2 score on a scale
Standard Deviation 4.3
|
11.4 score on a scale
Standard Deviation 5.5
|
SECONDARY outcome
Timeframe: Baseline, 3 monthsPopulation: The analytic sample included participants who completed 3-month assessment.
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.
Outcome measures
| Measure |
REACH VN Phone Intervention
n=25 Participants
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.
|
Enhanced Control
n=27 Participants
A single phone session focused on education about the nature of dementia.
|
|---|---|---|
|
Patient Health Questionnaire-4 (PHQ-4)
Baseline
|
4.3 score on a scale
Standard Deviation 3.4
|
4.8 score on a scale
Standard Deviation 3.9
|
|
Patient Health Questionnaire-4 (PHQ-4)
3-month
|
2.2 score on a scale
Standard Deviation 2.4
|
5.3 score on a scale
Standard Deviation 3.6
|
Adverse Events
REACH VN Phone Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Enhanced Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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