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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04272918
Enrollment
590
Registered
2020-02-17
Start date
2020-02-15
Completion date
2021-08-15
Last updated
2020-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caregiver Burnout, Case Management, Empowerment

Keywords

caregiver support, intensive case management, empowerment for caregivers

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.

Interventions

Examine the effectiveness of the Caregiver Support Model (CSM) on improving caregivers' well-being.

Examine the effectiveness of the Psycho-education Program (PP-E) on capacity building, empowerment, and improving well-being.

Sponsors

Simon K.Y.Lee Foundation
CollaboratorUNKNOWN
City University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

For CSM, participants will not know their status (treatment vs control) and the existence of the other group. For PPE, there will be no masked information but exchange of information and cross discussion between two groups will be discouraged. For outcome assessment, a coordinator will be used and assessors will not know beforehand whether the case to assess is from treatment or control group.

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes

Inclusion 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.

Design outcomes

Primary

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

Countries

Hong Kong

Contacts

Primary ContactYu Lung Marcus Chiu
mylchiu@cityu.edu.hk852 3442 5218

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026