- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06879457
mHealth Person-centred Self-care Support for Homebound Older Adults: A Hybrid Effectiveness-implementation Study
September 8, 2025 updated by: Arkers, Wong, The Hong Kong Polytechnic University
Empowering Homebound Older Adults in Self-care Using a Mobile Health-assisted, Person-centred Care Approach: A Hybrid Effectiveness-implementation Design
The aim of the study is to evaluate the effectiveness and implementation of the mobile health (mHealth)-assisted, person-centred care (PCC) self-care support programme for homebound older adults.
The researcher will compare PCC approach to a conventional care provider-led model.
Participants (n = 130) will receive the intervention of six bi-weekly WhatsApp video call sessions over three months with nurse case managers (NCMs).
Study Overview
Status
Recruiting
Detailed Description
This hybrid effectiveness-implementation, cluster-randomized controlled trial evaluates a mHealth-assisted, PCC self-care support programme for homebound older adults in Hong Kong.
Participants (n = 130) receive six bi-weekly WhatsApp video call sessions with NCMs over three months.
The study compares a PCC-based approach with a conventional provider-led model.
Effectiveness outcomes include self-efficacy, functional independence, and psychosocial well-being.
Implementation is assessed using the RE-AIM framework.
Findings will inform scalable, digital health interventions for aging populations, improving functional independence, self-care engagement, and healthcare accessibility for homebound older adults.
Study Type
Interventional
Enrollment (Estimated)
130
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
- Name: Prof. Arkers Wong
- Phone Number: +852 3400 3805
- Email: arkers.wong@polyu.edu.hk
Study Locations
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-
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Hong Kong, Hong Kong
- Recruiting
- Yan Oi Tong
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Contact:
- Ricky Liu, MSc
- Phone Number: +85234003805
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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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Aged 60 years or older;
- Unable to leave home more than twice per week due to physical or functional health problems;
- Own and have basic proficiency in using a smartphone;
- Speak Cantonese;
- Indicate sufficient cognitive ability; and
- Be moderately frail or below.
Exclusion Criteria:
- Unable to hear, see, or communicate effectively;
- Be completely bed-bound; or
- Reside in an area without stable internet coverage.
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: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group
The intervention group emphasizes shared decision-making, goal-setting, and interdisciplinary support.
The NCM will co-develop self-care plans with participants.
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Participants receive six bi-weekly WhatsApp video call sessions with a NCM over three months, using a person-centred care (PCC) approach.
|
|
Active Comparator: Control Group
The control group does not include shared decision-making or personalized goal-setting.
Self-care plans will be developed solely by the nurse case manager (NCM).
|
Participants receive six bi-weekly WhatsApp video call sessions with a NCM over three months, based on the conventional provider-led model.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in self-efficacy assessed using the Chinese version of the General Self-Efficacy Scale
Time Frame: At baseline, 3 months post-intervention , and 6 months post-intervention.
|
Unit of Measure: Mean score on self-efficacy.
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At baseline, 3 months post-intervention , and 6 months post-intervention.
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Change in instrumental activities of daily living assessed using the Chinese version of the Lawton Instrumental Activities of Daily Living Scale
Time Frame: At baseline, 3 months post-intervention , and 6 months post-intervention.
|
Unit of Measure: Mean score on instrumental activities of daily living.
|
At baseline, 3 months post-intervention , and 6 months post-intervention.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in quality of life assessed using the Chinese version of the 12-item Short Form Health Survey version 2
Time Frame: At baseline, 3 months post-intervention , and 6 months post-intervention.
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Unit of Measure: Mean score on quality of life.
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At baseline, 3 months post-intervention , and 6 months post-intervention.
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Change in psychological distress assessed using the Chinese version of 21-item Depression Anxiety Stress Scale
Time Frame: At baseline, 3 months post-intervention , and 6 months post-intervention.
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Unit of Measure: Mean score on psychological distress.
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At baseline, 3 months post-intervention , and 6 months post-intervention.
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Change in perceived loneliness assessed using the Chinese version of the UCLA 3-item Loneliness Scale
Time Frame: At baseline, 3 months post-intervention , and 6 months post-intervention.
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Unit of Measure: Mean score on perceived loneliness.
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At baseline, 3 months post-intervention , and 6 months post-intervention.
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Change in functional mobility assessed using the Timed Up and Go Test
Time Frame: At baseline, 3 months post-intervention , and 6 months post-intervention.
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Unit of Measure: Time in seconds.
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At baseline, 3 months post-intervention , and 6 months post-intervention.
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Change in sedentary behaviour assessed using the Chinese version of the Sedentary Behaviour Questionnaire for Elderly
Time Frame: At baseline, 3 months post-intervention , and 6 months post-intervention.
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Unit of Measure: Mean hours per day.
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At baseline, 3 months post-intervention , and 6 months post-intervention.
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Change in frequency of healthcare utilization assessed using the self-reported healthcare utilization survey
Time Frame: At baseline, 3 months post-intervention , and 6 months post-intervention.
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Unit of Measure: Number of visits.
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At baseline, 3 months post-intervention , and 6 months post-intervention.
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Participant reach and recruitment success measured by recruitment records
Time Frame: At baseline.
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Unit of Measure: Percentage of eligible enrollment.
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At baseline.
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Participant satisfaction with the intervention assessed using the Chinese version of four-dimension Client Satisfaction Questionnaire
Time Frame: At 3 months post-intervention and 6 months post-intervention.
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Unit of Measure: Mean score on satisfaction.
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At 3 months post-intervention and 6 months post-intervention.
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Service provider acceptability and adoption of person-centred care approach measured by focus group interview
Time Frame: At 3 months post-intervention.
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Unit of Measure: Thematic analysis of interview records.
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At 3 months post-intervention.
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Implementation fidelity and adherence to person-centred care principles measured by session recordings and fidelity checklist
Time Frame: Ongoing monitoring during intervention.
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Unit of Measure: 1).
Number and reasons for missed sessions; 2).
Percentage of sessions meeting fidelity criteria.
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Ongoing monitoring during intervention.
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Long-term maintenance and retention of participants measured by cost-effectiveness analysis and retention and dropout records
Time Frame: At 6 months post-intervention.
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Unit of Measure: 1).
Incremental cost-effectiveness ratio (ICER) per additional quality adjusted life year (QALY) gained; 2).
Number and reasons of dropout.
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At 6 months post-intervention.
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Barriers and Facilitators to the intervention measured by focus group interview
Time Frame: At 3 months post-intervention.
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Unit of Measure: Thematic analysis of interview records.
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At 3 months post-intervention.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Prof. Arkers Wong, School of Nursing, The Hong Kong Polytechnic University
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 (Actual)
March 10, 2025
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2027
Study Registration Dates
First Submitted
March 10, 2025
First Submitted That Met QC Criteria
March 14, 2025
First Posted (Actual)
March 17, 2025
Study Record Updates
Last Update Posted (Estimated)
September 15, 2025
Last Update Submitted That Met QC Criteria
September 8, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- HSEARS20240718004
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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