NCT06415617

Brief 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

  • 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 24, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 9, 2024

Completed
1 month until next milestone

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
Last Updated

May 16, 2024

Status Verified

May 1, 2024

Enrollment Period

5 months

First QC Date

May 10, 2024

Last Update Submit

May 10, 2024

Conditions

Keywords

Subjective well-beingfrailtypsychoeducation

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (8)

  • Frailty level

    12 weeks post-allocation

  • Physical functioning

    12 weeks post-allocation

  • Activities of daily living

    12 weeks post-allocation

  • Instrumental activities of daily living

    12 weeks post-allocation

  • Subjective well-being

    12 weeks post-allocation

  • +3 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" . The participants will be engaged in psychoeducation through group discussion, individualised goal setting and reflective exercises.

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 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)

You may not qualify if:

  • (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

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

Location

MeSH Terms

Conditions

FrailtyPsychological Well-Being

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsPersonal SatisfactionBehavior

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

November 24, 2023

Primary Completion

April 9, 2024

Study Completion

April 9, 2024

Last Updated

May 16, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations