A Nurse-led Family-oriented Resilience Program for Caregivers of Community-dwelling Dependent Older Adults
NCT Number: NCT06522516
Status: SUSPENDED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Caregiver Burden
Interventions: BEHAVIORAL: Evidence-based caregiving training|BEHAVIORAL: family resilience intervention|BEHAVIORAL: usual service
Sponsor: Central South University
Collaborators: Fudan University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 105
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2023-12-01
Completion Date: 2024-09-30
Locations: School of Nursing, Fudan University, Shanghai, Shanghai, 20023, China

Summary:
This is a 3-arm controlled trial. The participants are caregivers of the community-dwelling dependent older adults. There will be around 105 participants to be recruited and randomly allocated into 3 groups. Caregiving training group will receive a evidence-based caregiving training delivered via home visit of community nurse. Caregiving training plus family resilience group will additionally receive a structured family resilience intervetion. Control group will receive usual community health care service by nurses. The primary outcomes are caregiving ability, family resilience and psychological distress, and the secondary outcomes are caregiving burden, resilience, coping, social support, and quality of life the caregivers and the older adults. The measurement will be conducted four times at baseline, after, 1-month and 3-month after intervention.

Primary Outcome Measures: family resilience, The Walsh Family Resilience Questionnaire Chinese Version (WFRQ-C) is used to measure the level of family resilience of primary caregivers. The questionnaire includes three dimensions and 26 items: family beliefs, communication and resolution, and external support. The questionnaire items are evaluated using a Likert 5-point rating system, with scores ranging from 1 to 5 from "never" to "always". The higher the score, the higher the level of family resilience. The Cronbach's alpha coefficient of the questionnaire is 0.93, with a test-retest reliability of 0.96, indicating good validity., There will be 4 measurements, before, immediately after and，1-month, 3-month after the intervention.|psychological distress, Distress thermometer (DT): used to assess the level of psychological distress of primary caregivers. This scale was designed by Roth and translated into China by Tang Lili et al. in 2011. DT is a visual analog scale scale ranging from 0 to 10 points (0 indicates no psychological distress, 10 indicates extreme psychological distress). The reliability of the Chinese version DT retest is r=0.80, and the calibration validity is good., There will be 4 measurements, before, immediately after,1-month, and 3-month after the intervention.|caregiving ability, Caregiver Task Inventory (FCTI): used to measure the caregiving ability of primary caregivers. This scale consists of 5 dimensions (adapting to caregiver roles, responding to needs and providing assistance, handling personal emotions, evaluating family and community resource professionals, and adjusting life to meet caregiving needs), with a total of 25 items.The total score is 50 points, with higher scores indicating more caregiving difficulties for caregivers. The Cronbach's alpha coefficient of the scale is 0.93, indicating good construct validity., There will be 4 measurements, before, immediately after,1-month, and 3-month after the intervention.
Secondary Outcome Measures: caregiving burden, The Zarit Burden Inventory (ZBI) is used to measure the caregiving burden of primary caregivers. This scale is a self-assessment scale consisting of two dimensions: personal burden and responsibility burden, with a total of 22 items. The Cronbach's alpha coefficient of this scale is 0.87., There will be 4 measurements, before, immediately after,1-month, and 3-month after the intervention.|resilience, The Connor Davidson Resilience Scale (CD-RISC) is used to assess the psychological resilience of primary caregivers.The Chinese version of CD-RISC includes 3 dimensions (resilience, strength, and optimism), 25 items, and is rated on a scale of 1-5, with higher scores indicating higher levels of psychological resilience. The Cronbach's alpha coefficient of the scale is 0.91, indicating good criterion related validity., There will be 4 measurements, before, immediately after,1-month, and 3-month after the intervention.|coping, Simplified Coping Style Questionnaire (SCSQ): used to assess the coping strategies of primary caregivers. This scale was developed by Jie Yaning in 1998. It includes two dimensions (positive coping and negative coping), with 20 items. The positive coping dimension includes items 1-12, and the negative coping dimension includes items 13-20. It is rated on a scale of 0-3 out of 4. The higher the total score of the positive dimension, the more likely the survey respondents are to adopt positive coping methods; The higher the total score of the negative coping dimension, the more inclined the survey respondents are to adopt negative coping strategies. The Cronbach's alpha coefficient of the positive coping style in this scale is 0.89, and the Cronbach's alpha coefficient of the negative coping style is 0.78., There will be 4 measurements, before, immediately after,1-month, and 3-month after the intervention.|social support, Perceived Social Support Scale (PSSS): used to measure the perceived level of social support among primary caregivers. This scale was developed by Zemit in 1987 and later translated into Chinese by Huang Li et al. and introduced into China. This scale consists of 3 dimensions (family support, friend support, and other support), with a total of 12 items. It uses a 7-point scoring system ranging from 1 to 7, with higher total scores indicating higher levels of social support. The Cronbach's alpha coefficient of this scale is 0.92, indicating good test-retest reliability and construct validity., There will be 4 measurements, before, immediately after,1-month, and 3-month after the intervention.|Quality of life of caregiver, The European Five Dimensional Five Level (EQ-5D-5L) health scale: used to measure the quality of life of disabled elderly and primary caregivers. This scale was developed by the European Society for Quality of Life and includes a brief descriptive system questionnaire and a visual analog scale. The Cronbach's alpha coefficient of this scale is 0.857, indicating good validity., There will be 4 measurements, before, immediately after,1-month, and 3-month after the intervention.|Quality of life of older adults, The European Five Dimensional Five Level (EQ-5D-5L) health scale: used to measure the quality of life of disabled elderly and primary caregivers. This scale was developed by the European Society for Quality of Life and includes a brief descriptive system questionnaire and a visual analog scale. The Cronbach's alpha coefficient of this scale is 0.857, indicating good validity., There will be 4 measurements, before, immediately after, 1-month, and 3-month after the intervention.