Clinical trial NCT04272918: Caregiver Support Model & Psycho-Education Program On Empowerment: Development and Validation
Official title: Caregiver Support Model & Psycho-Education Program On Empowerment: Development and Validation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Caregiver Burnout
Case Management
Empowerment
Keywords: caregiver support
intensive case management
empowerment for caregivers
Lead sponsor: City University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Simon K.Y.Lee Foundation
First posted: 2020-02-17
Enrollment: 590
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This Project aims to provide social workers and relevant human service professionals with a comprehensive, scientific, and validated service model and suggest a sustainable support framework on the working process of helping and empowering family caregivers of frail elders, reducing caregiving distress, and enhancing caregivers' quality of life.

The proposed Project consists of two parts to be conducted in 1 year. The first part focuses on the development and validation of Caregiver Support Model (CSM) with a Randomized Controlled Trial (RCT) study. The second part develops and validates a psycho-education program on empowering family caregivers with another Randomized Controlled design. In the first year, the Project Team have (1) developed and designed different components of the Caregiver Support Model (CSM), including a comprehensive need assessment tool, personalized Caregiver Intervention Plan Guidelines and Template, and online database on caregiver services and community resources, (2) designed a five-session psycho-education program on empowerment. The Caregiver Needs Assessment (CNA) tool was also pilot-tested with 320 community caregivers. Results from the survey, together with the systematic review on caregiver support, will form the backbone of the later CNA implementation. The working model will be validated using RCT design with 400 family caregivers recruited through 4 collaborating NGOs. At the same time, a psycho-education program on empowerment will be developed and validated using RCT design with another 190 caregivers.

Detailed description: Participants of CSM will be randomly assigned to CSM intervention and non-CSM intervention which is the usual practice of case handling by centre staff. Randomization will be based on centres to prevent exchange of information between the two groups, and thus causing contamination. Outcome data will be measured at 3 time-intervals: case intake, 3-month, and 6-month.

Participants of the psychoeducation program on empowerment (PPE) will be randomly assigned to the program group and the non-program group. For the former a 5-session psychoeducation program will be administered. For both groups, outcome measures will be collected at pre, post, and 3-month after post test.

Eligibility criteria: CSM Inclusion Criteria:

* Primary family caregivers aged 21 or above;
* Have not received major/ intensive services in the past three months;
* Providing care for elderly aged 60 or older;
* Care recipient has at least one difficulty in activities of daily living or instrumental activities of daily living that needs help from the caregiver (scored 3 or higher on at least one of the items in the ADL/IADL Checklist).

PPE Inclusion Criteria:

* Primary family caregivers aged 21 or above;
* Family caregiving in stable situation or care recipient passed away within 2 years;
* Have not received systematic psychoeducation in the past three months.

Primary outcomes:
measure: Change of score in Zarit Burden Interview (Zarit, Reever, Bach-Peterson, 1980)
timeFrame: CSM: Change between baseline, 3 months and 6 months
measure: Change of score in WHO-5 (Topp et al. 2015)
timeFrame: CSM: Change between baseline, 3 months and 6 months
measure: Change of score in Meaning in caregiving (Yen et al., 2009)
timeFrame: PPE: Change between Baseline, 1 month and 3 months
measure: Change of score in Attitudes towards helping others (Webb, Green & Brashear，2000)
timeFrame: PPE: Change between Baseline, 1 month and 3 months
measure: Change of score in Revised scale for caregiving self-efficacy (Steffen et al., 2002)
timeFrame: PPE: Change between Baseline, 1 month and 3 months
measure: Change of score in Family Empowerment Scale (Koren, DeChillo and Friesen, 1992)
timeFrame: PPE: Change between Baseline, 1 month and 3 months
measure: Change of score in 5-level EQ-5D (EQ-5D-5L; EuroQol Group, 2009)
timeFrame: CSM: Change between baseline, 3 months and 6 months
measure: Change of score in General Health Questionnaire-12 (Goldberg & Williams, 1988)
timeFrame: CSM: Change between baseline, 3 months and 6 months
measure: Change of score in 7-item Peace of Mind Scale (Lee et al., 2013)
timeFrame: CSM: Change between baseline, 3 months and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: City University of Hong Kong
Study officials:
affiliation: City University of Hong Kong
name: Tit-wing LO
role: STUDY_DIRECTOR
affiliation: City University of Hong Kong
name: Kin-Kit (Ben) LI
role: STUDY_DIRECTOR
affiliation: City University of Hong Kong
name: Yuen Lan Dannii YEUNG
role: STUDY_DIRECTOR
References:
citation: Zarit SH, Reever KE, Bach-Peterson J. Relatives of the impaired elderly: correlates of feelings of burden. Gerontologist. 1980 Dec;20(6):649-55. doi: 10.1093/geront/20.6.649. No abstract available.
citation: Topp CW, Ostergaard SD, Sondergaard S, Bech P. The WHO-5 Well-Being Index: a systematic review of the literature. Psychother Psychosom. 2015;84(3):167-76. doi: 10.1159/000376585. Epub 2015 Mar 28.
citation: Yen WJ, Huang XY, Ma WF, Lee S, Lee CH. A Chinese version of the Meaning in Caregiving Scale: an assessment of its reliability and validity. Perspect Psychiatr Care. 2009 Apr;45(2):140-50. doi: 10.1111/j.1744-6163.2009.00214.x.
citation: Webb, D. J., Green, C. L., & Brashear, T. G. Development and validation of scales to measure attitudes influencing monetary donations to charitable organizations. Journal of the academy of marketing science, 28(2), 299-309, 2000
citation: Steffen AM, Gallagher-Thompson D, Arenella KM, Au A, Cheng ST, Crespo M, Cristancho-Lacroix V, Lopez J, Losada-Baltar A, Marquez-Gonzalez M, Nogales-Gonzalez C, Romero-Moreno R. Validating the Revised Scale for Caregiving Self-Efficacy: A Cross-National Review. Gerontologist. 2019 Jul 16;59(4):e325-e342. doi: 10.1093/geront/gny004.
citation: Koren, P. E., DeChillo, N., & Friesen, B. J. Measuring empowerment in families whose children have emotional disabilities: a brief questionnaire. Rehabilitation psychology, 37(4), 305, 1992.
citation: Lou VW, Lau BH, Cheung KS. Positive aspects of caregiving (PAC): scale validation among Chinese dementia caregivers (CG). Arch Gerontol Geriatr. 2015 Mar-Apr;60(2):299-306. doi: 10.1016/j.archger.2014.10.019. Epub 2014 Nov 7.
citation: Goldberg, D., & Williams, P. General health questionnaire (GHQ). Swindon, Wiltshire, UK: nferNelson, 2000.
citation: Lee, Y. C., Lin, Y. C., Huang, C. L., & Fredrickson, B. L. The construct and measurement of peace of mind. Journal of Happiness studies, 14(2), 571-590, 2013