Trial Outcomes & Findings for Volunteering Program for Chinese Dementia Caregivers (NCT NCT04346745)
NCT ID: NCT04346745
Last Updated: 2024-09-19
Results Overview
This outcome will be measured by Zarit's Burden Interview (ZBI). ZBI contains 22 items. Each item on the interview is a statement which the caregiver is asked to endorse using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always). In general, higher score indicates higher levels of burden. The full summed score ranges from 0 to 88, with higher scores indicating higher levels of burden (Cronbach's α = .80).
COMPLETED
NA
38 participants
Month 3, Month 9
2024-09-19
Participant Flow
Participant milestones
| Measure |
Treatment Group
The treatment group will receive intervention of a peer mentoring program plus usual services they could receive from community agencies.
Peer Mentoring Program: The Peer Mentoring Program (PMP) is a 3-month intervention to provide one-on-one mentoring support via phone calls to reduce the stress of Chinese dementia caregivers. The PMP will address the following topics: cultural beliefs about dementia and family caregiving, culturally effective coping strategies, and culturally appropriate social support.
|
Control Group
The control group received a package of educational materials on knowledge of dementia, caregiving skills.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
19
|
|
Overall Study
COMPLETED
|
18
|
16
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Volunteering Program for Chinese Dementia Caregivers
Baseline characteristics by cohort
| Measure |
Treatment Group
n=19 Participants
The treatment group will receive intervention of a peer mentoring program plus usual services they could receive from community agencies.
Peer Mentoring Program: The Peer Mentoring Program (PMP) is a 3-month intervention to provide one-on-one mentoring support via phone calls to reduce the stress of Chinese dementia caregivers. The PMP will address the following topics: cultural beliefs about dementia and family caregiving, culturally effective coping strategies, and culturally appropriate social support.
|
Control Group
n=19 Participants
The control group received a package of educational materials on knowledge of dementia, caregiving skills.
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Age, Continuous
|
67.11 years
STANDARD_DEVIATION 11.74 • n=5 Participants
|
67.16 years
STANDARD_DEVIATION 13.57 • n=7 Participants
|
67.13 years
STANDARD_DEVIATION 12.52 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 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
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
38 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
|
|
loneliness
|
4.74 units on a scale
STANDARD_DEVIATION 2.31 • n=5 Participants
|
4.18 units on a scale
STANDARD_DEVIATION 1.5 • n=7 Participants
|
4.46 units on a scale
STANDARD_DEVIATION 1.94 • n=5 Participants
|
|
caregiver burden
|
22.63 units on a scale
STANDARD_DEVIATION 9.96 • n=5 Participants
|
23.26 units on a scale
STANDARD_DEVIATION 6.64 • n=7 Participants
|
22.95 units on a scale
STANDARD_DEVIATION 8.36 • n=5 Participants
|
|
caregiving competency
|
13.08 units on a scale
STANDARD_DEVIATION 1.93 • n=5 Participants
|
13.00 units on a scale
STANDARD_DEVIATION 1.91 • n=7 Participants
|
13.04 units on a scale
STANDARD_DEVIATION 1.90 • n=5 Participants
|
|
Depressive symptoms
|
10.63 units on a scale
STANDARD_DEVIATION 7.95 • n=5 Participants
|
8.79 units on a scale
STANDARD_DEVIATION 6.45 • n=7 Participants
|
9.71 units on a scale
STANDARD_DEVIATION 7.20 • n=5 Participants
|
PRIMARY outcome
Timeframe: Month 3, Month 9Population: Four participants (1 in treatment group and 3 in control group) withdrew from the study before data was collected at Month 3.
This outcome will be measured by Zarit's Burden Interview (ZBI). ZBI contains 22 items. Each item on the interview is a statement which the caregiver is asked to endorse using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always). In general, higher score indicates higher levels of burden. The full summed score ranges from 0 to 88, with higher scores indicating higher levels of burden (Cronbach's α = .80).
Outcome measures
| Measure |
Treatment Group
n=18 Participants
The treatment group will receive intervention of a peer mentoring program plus usual services they could receive from community agencies.
Peer Mentoring Program: The Peer Mentoring Program (PMP) is a 3-month intervention to provide one-on-one mentoring support via phone calls to reduce the stress of Chinese dementia caregivers. The PMP will address the following topics: cultural beliefs about dementia and family caregiving, culturally effective coping strategies, and culturally appropriate social support.
|
Control Group
n=16 Participants
The control group received a package of educational materials on knowledge of dementia, caregiving skills.
|
|---|---|---|
|
Caregiver Burden Score at Month 3 and Month 9
Month 3
|
23.73 units on a scale
Standard Deviation 10.38
|
25.56 units on a scale
Standard Deviation 7.80
|
|
Caregiver Burden Score at Month 3 and Month 9
Month 9
|
21.41 units on a scale
Standard Deviation 11.89
|
27.67 units on a scale
Standard Deviation 8.00
|
PRIMARY outcome
Timeframe: Month 3, Month 9Population: Four participants (1 in treatment group and 3 in control group) withdrew from the study before data was collected at Month 3.
Depressive symptoms were measured by the 10-item Center for Epidemiological Studies Depression Scale (Andresen et al., 1994). Caregivers reported their depressive symptoms in the past week on a 4-point scale (from 0 = rarely or none of the time to 3 = most or all of the time). The summed scores ranged from 0 to 30, and higher scores indicated higher levels of depressive symptoms (Cronbach's α = .86).
Outcome measures
| Measure |
Treatment Group
n=18 Participants
The treatment group will receive intervention of a peer mentoring program plus usual services they could receive from community agencies.
Peer Mentoring Program: The Peer Mentoring Program (PMP) is a 3-month intervention to provide one-on-one mentoring support via phone calls to reduce the stress of Chinese dementia caregivers. The PMP will address the following topics: cultural beliefs about dementia and family caregiving, culturally effective coping strategies, and culturally appropriate social support.
|
Control Group
n=16 Participants
The control group received a package of educational materials on knowledge of dementia, caregiving skills.
|
|---|---|---|
|
Caregiver's Depression at Month 3 and Month 9
Month 3
|
12.48 units on a scale
Standard Deviation 7.56
|
13.00 units on a scale
Standard Deviation 7.69
|
|
Caregiver's Depression at Month 3 and Month 9
Month 9
|
9.61 units on a scale
Standard Deviation 7.78
|
11.88 units on a scale
Standard Deviation 6.62
|
PRIMARY outcome
Timeframe: Month 3, Month 9Population: Four participants (1 in treatment group and 3 in control group) withdrew from the study before data was collected at Month 3.
Caregiving competency was measured by the Caregiving Competence Scale. It is a 4-point Likert (not at all, just a little, somewhat, very much) scale including four questions: How do you believe that you've learned to deal with very difficult situations? How much do you feel that all in all, you're a good caregiver? How competent do you feel? How self-confident do you feel? We summed the scores of four items with higher scores indicating larger competence (Cronbach's alpha=0.62). The range of the score is 0-16.
Outcome measures
| Measure |
Treatment Group
n=18 Participants
The treatment group will receive intervention of a peer mentoring program plus usual services they could receive from community agencies.
Peer Mentoring Program: The Peer Mentoring Program (PMP) is a 3-month intervention to provide one-on-one mentoring support via phone calls to reduce the stress of Chinese dementia caregivers. The PMP will address the following topics: cultural beliefs about dementia and family caregiving, culturally effective coping strategies, and culturally appropriate social support.
|
Control Group
n=16 Participants
The control group received a package of educational materials on knowledge of dementia, caregiving skills.
|
|---|---|---|
|
Caregiving Competency at Month 3 and Month 9
Month 3
|
12.44 units on a scale
Standard Deviation 2.41
|
13.00 units on a scale
Standard Deviation 1.86
|
|
Caregiving Competency at Month 3 and Month 9
Month 9
|
13.00 units on a scale
Standard Deviation 3.61
|
12.5 units on a scale
Standard Deviation 2.85
|
PRIMARY outcome
Timeframe: Month 3, Month 9Population: Four participants (1 in treatment group and 3 in control group) withdrew from the study before data was collected at Month 3.
Loneliness was assessed by the Revised-University of California at Los Angeles Loneliness Scale. Caregivers rated their feelings of lacking companionship, left out of life, and isolation from others respectively on a 3-point scale (hardly ever, sometimes, often). We added up scores for the three questions to produce a continuous variable ranging from 0 to 6, with higher scores indicating higher levels of loneliness (Cronbach's alpha = 0.80).
Outcome measures
| Measure |
Treatment Group
n=18 Participants
The treatment group will receive intervention of a peer mentoring program plus usual services they could receive from community agencies.
Peer Mentoring Program: The Peer Mentoring Program (PMP) is a 3-month intervention to provide one-on-one mentoring support via phone calls to reduce the stress of Chinese dementia caregivers. The PMP will address the following topics: cultural beliefs about dementia and family caregiving, culturally effective coping strategies, and culturally appropriate social support.
|
Control Group
n=16 Participants
The control group received a package of educational materials on knowledge of dementia, caregiving skills.
|
|---|---|---|
|
Loneliness at Month 3 and Month 9
Month 3
|
4.56 units on a scale
Standard Deviation 2.04
|
5.44 units on a scale
Standard Deviation 2.00
|
|
Loneliness at Month 3 and Month 9
Month 9
|
5.11 units on a scale
Standard Deviation 2.32
|
5.31 units on a scale
Standard Deviation 2.47
|
Adverse Events
Treatment Group
Control Group
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