Caregiver Support Model & Psycho-Education Program On Empowerment: Development and Validation

Caregiver Burnout Clinical Trial

Official title:

Caregiver Support Model & Psycho-Education Program On Empowerment: Development and Validation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04272918
• Other study ID #: Carer Project
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2020
• Est. completion date: August 15, 2021

Study information

• Verified date: February 2020
• Source: City University of Hong Kong
• Contact: Yu Lung Marcus Chiu
• Phone: 852 3442 5218
• Email: mylchiu[@]cityu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 590
• Est. completion date: August 15, 2021
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Burnout, Psychological
• Caregiver Burnout
• Case Management
• Empowerment

Intervention

Behavioral:
• Caregiver Support Model
Examine the effectiveness of the Caregiver Support Model (CSM) on improving caregivers' well-being.
• Psycho-education Program
Examine the effectiveness of the Psycho-education Program (PP-E) on capacity building, empowerment, and improving well-being.

Locations

Country	Name	City	State
Hong Kong	City University of Hong Kong	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
City University of Hong Kong	Simon K.Y.Lee Foundation

Country where clinical trial is conducted

Hong Kong, 

References & Publications (9)

Goldberg, D., & Williams, P. General health questionnaire (GHQ). Swindon, Wiltshire, UK: nferNelson, 2000.

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.

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

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. — View Citation

Steffen AM, Gallagher-Thompson D, Arenella KM, Au A, Cheng ST, Crespo M, Cristancho-Lacroix V, López J, Losada-Baltar A, Márquez-González M, Nogales-González 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. — View Citation

Topp CW, Østergaard SD, Søndergaard 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. Review. — View 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

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of score in Zarit Burden Interview (Zarit, Reever, Bach-Peterson, 1980)	Zarit Burden Interview is a 12-item scale, and each item is scored 1 to 5 (1 = never; 5 = Always). It measures subjective burden among caregiver of adults with dementia, including functional/behavioral impairments and home care situation. Items are worded to focus on the affective response of the caregiver.	CSM: Change between baseline, 3 months and 6 months
Primary	Change of score in WHO-5 (Topp et al. 2015)	The WHO-5 is a short questionnaire consisting of 5 simple and non-invasive questions, which access 5 aspects of subjective well-being of the respondents Each of the 5 items is scored from 5 (all of the time) to 0 (none of the time).	CSM: Change between baseline, 3 months and 6 months
Primary	Change of score in Meaning in caregiving (Yen et al., 2009)	Meaning in caregiving was measured via the 12-item Meaning in Caregiving Scale developed by Ciuliano et al. (1990), translated by Yen et al., 2009. The instrument used a 5-point Likert scale: 1 (Strongly Disagree) to 5 (Strongly Agree).	PPE: Change between Baseline, 1 month and 3 months
Primary	Change of score in Attitudes towards helping others (Webb, Green & Brashear,2000)	Attitude toward helping others (AHO) is a 4-item measurement developed by Webb, Green and Brashear (2000) to measuring one's tendency to help or assist other people. Respondents answer each item using a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree).	PPE: Change between Baseline, 1 month and 3 months
Primary	Change of score in Revised scale for caregiving self-efficacy (Steffen et al., 2002)	The RSCSE is a 15-item measurement which can assesses caregivers' confidence in responding to three domains of caregiving: obtaining respite, managing disruptive behaviors, and controlling upsetting thoughts. The scale is scored from 0 (cannot do at all) to 10 (certain can do).	PPE: Change between Baseline, 1 month and 3 months
Primary	Change of score in Family Empowerment Scale (Koren, DeChillo and Friesen, 1992)	The Family Empowerment Scale is a 34-item questionnaire developed by Koren, DeChillo and Friesen (1992) for assessing the 3 aspects of empowerment in family: family, service and community. A 5-point scale is used (1 = not at all; 5 = very true).	PPE: Change between Baseline, 1 month and 3 months
Primary	Change of score in 5-level EQ-5D (EQ-5D-5L; EuroQol Group, 2009)	The 5-level EQ-5D version (EQ-5D-5L) was introduced by the EuroQol Group (2009), assessing five dimensions including mobility, self-care,, usual activities, pain/discomfort and anxiety/depression on a 5-point scale, ranging from 1 to 5 (1 = no problem at all; 5 = extremely worse condition)	CSM: Change between baseline, 3 months and 6 months
Primary	Change of score in General Health Questionnaire-12 (Goldberg & Williams, 1988)	The General Health Questionnaire-12 is a shortened version of the General Health Questionnaire scored on a 4-point scale, developed by Goldberg and Williams (1998), designed to measure the risk of developing psychiatric disorders and assess general well-being of a person.	CSM: Change between baseline, 3 months and 6 months
Primary	Change of score in 7-item Peace of Mind Scale (Lee et al., 2013)	The Peace of Mind Scale consist of 7 items, measuring one's internal state of peacefulness and harmony among Chinese culture. It is scored 1 to 5 (1 = never; 5 = always)	CSM: Change between baseline, 3 months and 6 months