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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06415617
Other study ID # 2023.585.p
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 24, 2023
Est. completion date April 9, 2024

Study information

Verified date May 2024
Source Chinese University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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 1. Are the proposed eligibility criteria for participants and the study process in recruiting and retaining the participants appropriate? 2. 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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date April 9, 2024
Est. primary completion date April 9, 2024
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


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" . The participants will be engaged in psychoeducation through group discussion, individualised goal setting and reflective exercises.
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 Participation rate, self-reported intervention adherence, and attrition rate. The feasibility of the study will be measured in terms of participation rate, self-reported intervention adherence, and attrition rate. 12 weeks post-allocation
Primary Acceptability 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
Secondary Frailty level FRAIL scale 12 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. 12 weeks post-allocation
Secondary Activities of daily living Katz Index of Independence in Activities of Daily Living 12 weeks post-allocation
Secondary Instrumental activities of daily living Lawton Instrumental Activities of Daily Living Scale 12 weeks post-allocation
Secondary Subjective well-being The Chinese 5-item World Health Organization Well-Being Index 12 weeks post-allocation
Secondary Depressive symptoms 4-item Geriatric Depression scale 12 weeks post-allocation
Secondary Social support 10-item Duke Social Support Index 12 weeks post-allocation
Secondary Quality of life EuroQol 5-Dimension 5-Level 12 weeks post-allocation
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