- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06415604
Home-based Psychoeducation for Older Adults With Frailty: A Randomised Controlled Trial
Effects of a Home-based Psychoeducation on Subjective Well-being for Older Adults With Frailty in the Community: A Randomised Controlled Trial
This study aims to examine the effectiveness of a 12-week home-based telerehabilitation programme on improving subjective well-being among community-dwelling older people with frailty.
The main question it aims to answer is
- Could home-based psychoeducation significantly enhance subjective well-being in older adults with frailty in the community?
Participants will receive 12 weekly online group-based sessions at their homes. The content for the experimental group and control group is different:
- Intervention group: psychoeducation
- Control group: physical health education Participants will receive three home visits for data collection. Some of participants in experimental group will receive interview for process evaluation.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: An TAO
- Phone Number: (852) 39439929
- Email: andersontao@link.cuhk.edu.hk
Study Locations
-
-
New Territories
-
Shatin, New Territories, Hong Kong
- Recruiting
- The Nethersole School of Nursing, The Chinese University of Hong Kong
-
Contact:
- An TAO
- Phone Number: (+852) 39439929
- Email: andersontao@link.cuhk.edu.hk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
(1) Aged 65 or older; (2) Identified as frail by the FRAIL scale (score ≥3); (3) Mentally competent as determined by the Abbreviated Mental Test (AMT ≥6); (4) Able to speak and understand Cantonese; (5) Living at home; (6) Experienced in using a smartphone (e.g., sending messages, watching videos).
Exclusion Criteria:
(1) Have visual or hearing impairments or language barriers that may impact communication or understanding; (2) Unfit for home-based exercise, as indicated by a score of 1 or higher on the 25-item HOME-FAST, a tool for identifying home fall hazards; (3) Currently engaging in exercise for at least 150 minutes per week over the past four weeks; (4) Undergoing active psychiatric or antidepressant treatment or participating in other physical exercise or rehabilitation programs.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental group
Participants will receive 60-minute weekly online group-based psychoeducation sessions for 12 weeks.
|
The content of psychoeducation is based on "Five Ways of Well-being" which covers "Be active", "Connect", "Take Notice", "Keep learning" and "Giving".
|
Active Comparator: Control group
Participants will receive 60-minute weekly online group-based physical health sessions for 12 weeks.
|
The content of the sessions mainly focuses on physical health information, such as healthy eating, physical exercise, prevention of falls, and pain management.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subjective well-being
Time Frame: baseline, 12 weeks post-allocation, 24 weeks post-allocation
|
The Chinese 5-item World Health Organization Well-Being Index
|
baseline, 12 weeks post-allocation, 24 weeks post-allocation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frailty level
Time Frame: baseline, 12 weeks post-allocation, 24 weeks post-allocation
|
FRAIL scale
|
baseline, 12 weeks post-allocation, 24 weeks post-allocation
|
Physical functioning
Time Frame: baseline, 12 weeks post-allocation, 24 weeks post-allocation
|
The Senior Fitness Test: It covers four dimensions, including muscle endurance, balance, flexibility, and tolerance measured by 30-sec arm-curl test, 30-sec chair-stand test, back-scratch test, chair sit-and-reach test, 8-foot up-and-go test, two-min step test
|
baseline, 12 weeks post-allocation, 24 weeks post-allocation
|
Activities of daily living
Time Frame: baseline, 12 weeks post-allocation, 24 weeks post-allocation
|
Katz Index of Independence in Activities of Daily Living
|
baseline, 12 weeks post-allocation, 24 weeks post-allocation
|
Instrumental activities of daily living
Time Frame: baseline, 12 weeks post-allocation, 24 weeks post-allocation
|
Lawton Instrumental Activities of Daily Living Scale
|
baseline, 12 weeks post-allocation, 24 weeks post-allocation
|
Depressive symptoms
Time Frame: baseline, 12 weeks post-allocation, 24 weeks post-allocation
|
4-item Geriatric Depression scale
|
baseline, 12 weeks post-allocation, 24 weeks post-allocation
|
Social support
Time Frame: baseline, 12 weeks post-allocation, 24 weeks post-allocation
|
10-item Duke Social Support Index
|
baseline, 12 weeks post-allocation, 24 weeks post-allocation
|
Quality of life
Time Frame: baseline, 12 weeks post-allocation, 24 weeks post-allocation
|
EuroQol 5-Dimension 5-Level
|
baseline, 12 weeks post-allocation, 24 weeks post-allocation
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023.585.M
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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