- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06415617
Home-based Psychoeducation for Older Adults With Frailty: A Feasibility Trial
Effects of A Home-based Psychoeducation Programme on Subjective Well-being for Older Adults With Frailty in the Community: A Feasibility Trial
This study aims to test the feasibility and acceptability of home-based psychoeducation in older adults with frailty in the community. The main questions it aims to answer are
- Are the proposed eligibility criteria for participants and the study process in recruiting and retaining the participants appropriate?
- Is home-based psychoeducation feasible and acceptable for 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 two home visits for data collection. An individual interview will be conducted with participants in the experimental group to explore their experiences.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New Territories
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Shatin, New Territories, Hong Kong
- The Nethersole School of Nursing, The Chinese University of Hong Kong
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
(1) aged 65 years or over; (2) meeting frailty criteria by FRAIL scale (score 3 or above) ; (3) mentally competent screened by The Abbreviated Mental Test (AMT≥6) ; (4) able to speak and understand Cantonese; (5) living at home; (6) having experience using a smartphone (e.g.: sending messages, watching videos)
Exclusion Criteria:
(1) have a visual or hearing problem or a language barrier that may affect their communication or understanding; (2) being unfit for home-based exercise, as defined by having one point or above at either the 25-item Home Falls and Accidents self-reported screening tool (HOME-FAST), which is a comprehensive tool for identify home hazards for fall (3) are currently practising exercise for at least 150 minutes per week in previous four weeks; (4) are receiving active psychiatric or antidepressant treatment or joining other physical exercises or rehabilitation programmes
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.
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The content of psychoeducation is based on "Five Ways of Well-being" which covers "Be active", "Connect", "Take Notice", "Keep learning" and "Giving" .
The participants will be engaged in psychoeducation through group discussion, individualised goal setting and reflective exercises.
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Active Comparator: Control group
Participants will receive 60-minute weekly online group-based physical health sessions for 12 weeks.
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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 |
|---|---|---|
|
Participation rate, self-reported intervention adherence, and attrition rate.
Time Frame: 12 weeks post-allocation
|
The feasibility of the study will be measured in terms of participation rate, self-reported intervention adherence, and attrition rate.
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12 weeks post-allocation
|
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Acceptability
Time Frame: 12 weeks post-allocation
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A 5-item satisfaction survey will be conducted by the end of the intervention for participants to rate the intervention in terms of appropriates of the session content, length of each session, overall intervention duration and delivery mode, from 1 (very dissatisfied) to 5 (very satisfied).
|
12 weeks post-allocation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Frailty level
Time Frame: 12 weeks post-allocation
|
FRAIL scale
|
12 weeks post-allocation
|
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Physical functioning
Time Frame: 12 weeks post-allocation
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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.
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12 weeks post-allocation
|
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Activities of daily living
Time Frame: 12 weeks post-allocation
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Katz Index of Independence in Activities of Daily Living
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12 weeks post-allocation
|
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Instrumental activities of daily living
Time Frame: 12 weeks post-allocation
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Lawton Instrumental Activities of Daily Living Scale
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12 weeks post-allocation
|
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Subjective well-being
Time Frame: 12 weeks post-allocation
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The Chinese 5-item World Health Organization Well-Being Index
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12 weeks post-allocation
|
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Depressive symptoms
Time Frame: 12 weeks post-allocation
|
4-item Geriatric Depression scale
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12 weeks post-allocation
|
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Social support
Time Frame: 12 weeks post-allocation
|
10-item Duke Social Support Index
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12 weeks post-allocation
|
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Quality of life
Time Frame: 12 weeks post-allocation
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EuroQol 5-Dimension 5-Level
|
12 weeks post-allocation
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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.p
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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