NCT06415604

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
138

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 16, 2024

Completed
16 days until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

May 16, 2024

Status Verified

May 1, 2024

Enrollment Period

7 months

First QC Date

May 10, 2024

Last Update Submit

May 10, 2024

Conditions

Keywords

Subjective well-beingfrailtypsychoeducation

Outcome Measures

Primary Outcomes (1)

  • Subjective well-being

    The Chinese 5-item World Health Organization Well-Being Index

    baseline, 12 weeks post-allocation, 24 weeks post-allocation

Secondary Outcomes (7)

  • Frailty level

    baseline, 12 weeks post-allocation, 24 weeks post-allocation

  • Physical functioning

    baseline, 12 weeks post-allocation, 24 weeks post-allocation

  • Activities of daily living

    baseline, 12 weeks post-allocation, 24 weeks post-allocation

  • Instrumental activities of daily living

    baseline, 12 weeks post-allocation, 24 weeks post-allocation

  • Depressive symptoms

    baseline, 12 weeks post-allocation, 24 weeks post-allocation

  • +2 more secondary outcomes

Study Arms (2)

Experimental group

EXPERIMENTAL

Participants will receive 60-minute weekly online group-based psychoeducation sessions for 12 weeks.

Other: Psychoeducation

Control group

ACTIVE COMPARATOR

Participants will receive 60-minute weekly online group-based physical health sessions for 12 weeks.

Other: Attention control

Interventions

The content of psychoeducation is based on "Five Ways of Well-being" which covers "Be active", "Connect", "Take Notice", "Keep learning" and "Giving".

Experimental group

The content of the sessions mainly focuses on physical health information, such as healthy eating, physical exercise, prevention of falls, and pain management.

Control group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • (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).

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Nethersole School of Nursing, The Chinese University of Hong Kong

Shatin, New Territories, Hong Kong

RECRUITING

MeSH Terms

Conditions

FrailtyPsychological Well-Being

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsPersonal SatisfactionBehavior

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Mr

Study Record Dates

First Submitted

May 10, 2024

First Posted

May 16, 2024

Study Start

June 1, 2024

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

May 16, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations