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

February 20, 2020 updated by: Dr. CHIU Yu Lung Marcus, City University of Hong Kong

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

590

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong, KLN
        • Recruiting
        • City University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: CSM condition
Social Worker 1 of CSM conditions will work with caregivers according to the guidelines and template of the Care Support Model, including the formulation of the intervention plan based on CNA scores of different need domains, the use of the caregiver intervention plan template, service matching drawing reference from caregiver resource database, service formulation based on CNA scores of different strength domains, the use of the case monitoring template and guideline.
Behavioral: Caregiver Support Model
Examine the effectiveness of the Caregiver Support Model (CSM) on improving caregivers' well-being.
NO_INTERVENTION: Non-CSM condition
Social Worker 2 of the Control Group will not be notified of the CNA scores of his/her caregivers. The intervention plan, services assignment and case management of participants of the control group will be based on Social Worker 2's own judgement using the information shared by the caregivers, and the social worker's own observation.
EXPERIMENTAL: PP-E condition
Experimental Group will be led a consultant who is an expert, with the help of a degree-holder social worker to facilitate capacity building, empowerment and long-term well-being. Measurement of outcome variables will be conducted before the start of the program, at the end of the program, and 3 months after the program ended.
Behavioral: Psycho-education Program
Examine the effectiveness of the Psycho-education Program (PP-E) on capacity building, empowerment, and improving well-being.
NO_INTERVENTION: Non PP-E condition
Measurement of outcome variables will be conducted at the same point of time as PP-E condition. There will be no treatment or intervention for the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of score in Zarit Burden Interview (Zarit, Reever, Bach-Peterson, 1980)
Time Frame: CSM: Change between baseline, 3 months and 6 months
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
Change of score in WHO-5 (Topp et al. 2015)
Time Frame: CSM: Change between baseline, 3 months and 6 months
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
Change of score in Meaning in caregiving (Yen et al., 2009)
Time Frame: PPE: Change between Baseline, 1 month and 3 months
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
Change of score in Attitudes towards helping others (Webb, Green & Brashear，2000)
Time Frame: PPE: Change between Baseline, 1 month and 3 months
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
Change of score in Revised scale for caregiving self-efficacy (Steffen et al., 2002)
Time Frame: PPE: Change between Baseline, 1 month and 3 months
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
Change of score in Family Empowerment Scale (Koren, DeChillo and Friesen, 1992)
Time Frame: PPE: Change between Baseline, 1 month and 3 months
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
Change of score in 5-level EQ-5D (EQ-5D-5L; EuroQol Group, 2009)
Time Frame: CSM: Change between baseline, 3 months and 6 months
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
Change of score in General Health Questionnaire-12 (Goldberg & Williams, 1988)
Time Frame: CSM: Change between baseline, 3 months and 6 months
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
Change of score in 7-item Peace of Mind Scale (Lee et al., 2013)
Time Frame: CSM: Change between baseline, 3 months and 6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City University of Hong Kong

Collaborators

Simon K.Y.Lee Foundation

Investigators

  • Study Director: Tit-wing LO, City University of Hong Kong
  • Study Director: Kin-Kit (Ben) LI, City University of Hong Kong
  • Study Director: Yuen Lan Dannii YEUNG, City University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

February 15, 2020

Primary Completion (ANTICIPATED)

December 30, 2020

Study Completion (ANTICIPATED)

August 15, 2021

Study Registration Dates

First Submitted

February 9, 2020

First Submitted That Met QC Criteria

February 14, 2020

First Posted (ACTUAL)

February 17, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 21, 2020

Last Update Submitted That Met QC Criteria

February 20, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Carer Project

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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