An interventional study of Peer Mentoring Program in Caregiver Burnout, sponsored by Columbia University. Completed at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Columbia University · Not applicable, Interventional, and Supportive care
Although many older Chinese Americans are expected to need intensive care because of cognitive impairment, a large gap exists in development of culturally sensitive interventions to reduce stress among caregivers in Chinese American communities. This research project will develop and pilot test a culturally sensitive intervention, the peer mentoring program (PMP), which is informed by the sociocultural stress and coping model. This project will generate preliminary data for a larger randomized controlled trial for efficacy or effectiveness testing of PMP, which is an innovative intervention to support dementia among Chinese Americans, by empowering the existing human resources of experiential caregivers in the same ethnic community.
Providing care for a family member with Alzheimer's disease and related dementia (ADRD) negatively affects caregivers' physical and mental health.Despite numerous studies on developing interventions for ADRD family caregivers of Caucasian Americans, it is not clear what interventions are effective in reducing the stress of family caregivers of Asian Americans. The purpose of this study is to develop a culturally sensitive and effective intervention to reduce the stress of dementia caregivers of Chinese Americans. It is necessary to prioritize Chinese American ADRD caregiving research because of: (a) the increasing needs of ADRD caregivers of Chinese Americans, the largest and fastest-growing ethnic group of Asians in the United States; (b) erroneous conclusions about Chinese American health in current research and policy practices due to omission, aggregation, and extrapolation; (c) health inequality issues ignored by the "model minority" stereotype of Asian Americans in general; (d) mental health vulnerabilities of older Chinese Americans; and (e) unresolved challenges of Chinese American caregivers such as lack of health literacy, concerns about stigma, failure to maintain family harmony, social isolation, and barriers to accessing culturally competent services. Given these concerns and the lack of health professionals who can speak Chinese and understand Chinese culture and norms, this study aims to develop a peer mentoring program to support dementia caregivers by empowering the human resources of experiential caregivers in Chinese American communities.
Informed by the sociocultural stress and coping model and relevant empirical evidence, the investigators designed the Peer Mentoring Program (PMP) to train and monitor experiential caregivers in providing mentoring support for caregivers in the same ethnic community. Experiential caregivers in the same ethnic community could understand the caregiving journey embedded in Chinese cultural values and the international migration experience. In the PMP, experiential caregivers will be hired and trained as volunteer peer mentors and monitored in providing mentoring support to dementia caregivers to address cultural beliefs about dementia and family caregiving, develop culturally effective coping strategies, and enhance culturally appropriate social support. The intervention is promising given the needs of Chinese caregivers, positive results of a previous trial in a senior volunteer program in Chinese Americans communities, benefits of volunteering for older adults, preliminary analysis results of data from our pilot study (70% Chinese caregivers reported a desire to receive peer mentoring support), and the potential of developing a cost-effective and sustainable intervention that could be applied in other racial and ethnic minority communities.
This proposed study will use a community-based participatory research (CBPR) approach based on a partnership of multidisciplinary researchers, health professionals, family caregivers and older volunteers in NYC to accomplish Stage 0 (Aim1) and Stage I (Aims 2 and 3) for behavioral intervention development and to develop Stage II and/or Stage IV (Aim 3).
Aim 1: To study the challenges and enablers of successful caregiving for persons with ADRD in Chinese American communities in New York City (NYC). The investigators will analyze recently collected data from in-depth interviews and questionnaire-based surveys to identify robust challenges, barriers, resources, and successful coping strategies among these caregivers, which will help develop the PMP intervention manual.
Aim 2: To develop the PMP intervention protocol. Using the analysis results from Aim 1 in collaboration with multidisciplinary researchers and professionals, I will develop the volunteer training manual, intervention protocol, and screening and evaluation tools.
Aim 3: To examine the feasibility and acceptability of PMP. A pilot randomized clinical trial of five volunteers and 30 caregivers (15 to intervention, 15 to control) will be conducted. Qualitative and quantitative data from caregivers, volunteers, and professional collaborators will be collected to evaluate feasibility and acceptability of recruitment, randomization, intervention adherence, treatment fidelity, and administration of measures. Based on the results of feasibility and acceptability test, The investigators will refine the intervention and inform a subsequent larger randomized control trial (RCT) to initiate an efficacy or hybrid stage of intervention development.
439 studies on the registry are indexed under Caregiver Burden; 154 are open to participants now.
This study's enrollment of 38 is below the median of 75 across 346 interventional studies indexed under Caregiver Burden.
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Of its 179 completed or terminated interventional studies of FDA-regulated products, 146 (82%) have results posted.
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Inclusion Criteria:
The caregivers will be recruited if they:
Inclusion Criteria:
The volunteer mentors will be recruited if they:
Exclusion Criteria for both groups:
The treatment group will receive intervention of a peer mentoring program plus usual services they could receive from community agencies.
Behavioral: Peer Mentoring Program
The control group received a package of educational materials on knowledge of dementia, caregiving skills.
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.
Caregiver Burden Score at Month 3 and Month 9
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).
Time frame: Month 3, Month 9
Caregiver's Depression at Month 3 and Month 9
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).
Time frame: Month 3, Month 9
Caregiving Competency at Month 3 and Month 9
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.
Time frame: Month 3, Month 9
Loneliness at Month 3 and Month 9
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).
Time frame: Month 3, Month 9
| Milestone | Treatment Group | Control Group |
|---|---|---|
| Started | 19 | 19 |
| Completed | 18 | 16 |
| Not completed | 1 | 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).
| units on a scale | Treatment Group | Control Group |
|---|---|---|
| Month 3 | 23.73 ± 10.38 | 25.56 ± 7.80 |
| Month 9 | 21.41 ± 11.89 | 27.67 ± 8.00 |
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).
| units on a scale | Treatment Group | Control Group |
|---|---|---|
| Month 3 | 12.48 ± 7.56 | 13.00 ± 7.69 |
| Month 9 | 9.61 ± 7.78 | 11.88 ± 6.62 |
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.
| units on a scale | Treatment Group | Control Group |
|---|---|---|
| Month 3 | 12.44 ± 2.41 | 13.00 ± 1.86 |
| Month 9 | 13.00 ± 3.61 | 12.5 ± 2.85 |
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).
| units on a scale | Treatment Group | Control Group |
|---|---|---|
| Month 3 | 4.56 ± 2.04 | 5.44 ± 2.00 |
| Month 9 | 5.11 ± 2.32 | 5.31 ± 2.47 |
Collected over 9 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment Group | 0/19 (0%) | 0/19 (0%) | 0/19 (0%) |
| Control Group | 0/19 (0%) | 0/19 (0%) | 0/19 (0%) |
| Age, Categorical(Participants) | Treatment Group | Control Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 8 | 7 | 15 |
| >=65 years | 11 | 12 | 23 |
| Age, Continuous(years) | Treatment Group | Control Group | Total |
|---|---|---|---|
| Mean | 67.11 ± 11.74 | 67.16 ± 13.57 | 67.13 ± 12.52 |
| Sex: Female, Male(Participants) | Treatment Group | Control Group | Total |
|---|---|---|---|
| Female | 17 | 18 | 35 |
| Male | 2 | 1 | 3 |
| Race (NIH/OMB)(Participants) | Treatment Group | Control Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 19 | 19 | 38 |
| 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 |
| loneliness(units on a scale) | Treatment Group | Control Group | Total |
|---|---|---|---|
| Mean | 4.74 ± 2.31 | 4.18 ± 1.5 | 4.46 ± 1.94 |
| caregiver burden(units on a scale) | Treatment Group | Control Group | Total |
|---|---|---|---|
| Mean | 22.63 ± 9.96 | 23.26 ± 6.64 | 22.95 ± 8.36 |
| caregiving competency(units on a scale) | Treatment Group | Control Group | Total |
|---|---|---|---|
| Mean | 13.08 ± 1.93 | 13.00 ± 1.91 | 13.04 ± 1.90 |
| Depressive symptoms(units on a scale) | Treatment Group | Control Group | Total |
|---|---|---|---|
| Mean | 10.63 ± 7.95 | 8.79 ± 6.45 | 9.71 ± 7.20 |
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