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Caregiver BurnoutNCT04272918

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

A study testing Caregiver Support Model and Psycho-education Program in people with Caregiver Burnout and Case Management, run by City University of Hong Kong at 1 site in Hong Kong.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 21 years and olderHealthy volunteers can take part
Conditions the study is for
Caregiver Burnout, Case Management, Empowerment
What is being tested?
Caregiver Support Model and Psycho-education Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
590 participants
Where
1 siteHong Kong
Study dates
15 Feb 2020to 15 Aug 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Trial locations and contacts

1 site in 1 country.

Yu Lung Marcus Chiu contact

852 3442 5218 ext. 5218

mylchiu@cityu.edu.hk

Hong Kong1 site, 1 recruiting

  • City University of Hong Kong

    Hong Kong, KLN

    Recruiting

Other trials in Hong Kong

About this study

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.

Read the 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.

Being tested
Caregiver Support Model, Psycho-education Program
Keywords
caregiver support, intensive case management, empowerment for caregivers
Medical subject headings
Caregiver Burden, Empowerment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Caregiver Support ModelBehavioural

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

  • Psycho-education ProgramBehavioural

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

Study groups in NCT04272918
Study groupRoleWhat they receive
CSM conditionExperimentalSocial 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.
Receives: Behavioral: Caregiver Support Model
Non-CSM conditionNo interventionSocial 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.
PP-E conditionExperimentalExperimental 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.
Receives: Behavioral: Psycho-education Program
Non PP-E conditionNo interventionMeasurement 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: CSM: Change between baseline, 3 months and 6 months

  2. 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).

    Measured: CSM: Change between baseline, 3 months and 6 months

  3. 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).

    Measured: PPE: Change between Baseline, 1 month and 3 months

  4. 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).

    Measured: PPE: Change between Baseline, 1 month and 3 months

  5. 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).

    Measured: PPE: Change between Baseline, 1 month and 3 months

  6. 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).

    Measured: PPE: Change between Baseline, 1 month and 3 months

  7. 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)

    Measured: CSM: Change between baseline, 3 months and 6 months

  8. 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.

    Measured: CSM: Change between baseline, 3 months and 6 months

  9. 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)

    Measured: CSM: Change between baseline, 3 months and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2020
  2. Study start15 Feb 2020 (estimated)
  3. Primary completion30 Dec 2020 (estimated)
  4. Study completion15 Aug 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
590 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04272918
Sponsor's protocol ID
Carer Project
Status last verified
Feb 2020
First submitted
9 Feb 2020
Last updated
21 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 7203086

  • 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.

    PubMed 25831962

  • 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.

    PubMed 19366424

  • 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

  • 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.

    PubMed 29546334

  • 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.

  • 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.

    PubMed 25488014

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

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Caregiver Support Model and Psycho-education Program in people with Caregiver Burnout and Case Management, run by City University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yu Lung Marcus Chiu (852 3442 5218 ext. 5218, mylchiu@cityu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of score in Zarit Burden Interview (Zarit, Reever, Bach-Peterson, 1980) (time frame: CSM: Change between baseline, 3 months and 6 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04272918, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2020.

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