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

Frailty Clinical Trial

Official title:

Effects of a Home-based Psychoeducation on Subjective Well-being for Older Adults With Frailty in the Community: A Randomised Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06415604
• Other study ID #: 2023.585.M
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: January 1, 2025

Study information

• Verified date: May 2024
• Source: Chinese University of Hong Kong
• Contact: An TAO
• Phone: (852) 39439929
• Email: andersontao[@]link.cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 138
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Frailty

Intervention

Other:
• Psychoeducation
The content of psychoeducation is based on "Five Ways of Well-being" which covers "Be active", "Connect", "Take Notice", "Keep learning" and "Giving".
• Attention control
The content of the sessions mainly focuses on physical health information, such as healthy eating, physical exercise, prevention of falls, and pain management.

Locations

Country	Name	City	State
Hong Kong	The Nethersole School of Nursing, The Chinese University of Hong Kong	Shatin	New Territories

Sponsors (1)

Lead Sponsor	Collaborator
TAO An

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective well-being	The Chinese 5-item World Health Organization Well-Being Index	baseline, 12 weeks post-allocation, 24 weeks post-allocation
Secondary	Frailty level	FRAIL scale	baseline, 12 weeks post-allocation, 24 weeks post-allocation
Secondary	Physical functioning	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
Secondary	Activities of daily living	Katz Index of Independence in Activities of Daily Living	baseline, 12 weeks post-allocation, 24 weeks post-allocation
Secondary	Instrumental activities of daily living	Lawton Instrumental Activities of Daily Living Scale	baseline, 12 weeks post-allocation, 24 weeks post-allocation
Secondary	Depressive symptoms	4-item Geriatric Depression scale	baseline, 12 weeks post-allocation, 24 weeks post-allocation
Secondary	Social support	10-item Duke Social Support Index	baseline, 12 weeks post-allocation, 24 weeks post-allocation
Secondary	Quality of life	EuroQol 5-Dimension 5-Level	baseline, 12 weeks post-allocation, 24 weeks post-allocation