Home-based Psychoeducation for Older Adults With Frailty: A Randomised Controlled Trial

May 10, 2024 updated by: TAO An

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

Recruiting

Study Type

Interventional

Enrollment (Estimated)

138

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

    • New Territories
      • Shatin, New Territories, Hong Kong
        • Recruiting
        • The Nethersole School of Nursing, The Chinese University of Hong Kong
        • Contact:

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

  • Older Adult

Accepts Healthy Volunteers

No

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

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: 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

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

Sponsor

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 (Estimated)

June 1, 2024

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

May 10, 2024

First Submitted That Met QC Criteria

May 10, 2024

First Posted (Actual)

May 16, 2024

Study Record Updates

Last Update Posted (Actual)

May 16, 2024

Last Update Submitted That Met QC Criteria

May 10, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023.585.M

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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