Clinical trial NCT06879457: mHealth Person-centred Self-care Support for Homebound Older Adults: A Hybrid Effectiveness-implementation Study
Official title: Empowering Homebound Older Adults in Self-care Using a Mobile Health-assisted, Person-centred Care Approach: A Hybrid Effectiveness-implementation Design
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mobile Health
Person-Centred Care
Self-Care
Homebound
Older Adults
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2025-03-17
Enrollment: 130
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in self-efficacy assessed using the Chinese version of the General Self-Efficacy Scale
timeFrame: At baseline, 3 months post-intervention , and 6 months post-intervention.
measure: Change in instrumental activities of daily living assessed using the Chinese version of the Lawton Instrumental Activities of Daily Living Scale
timeFrame: At baseline, 3 months post-intervention , and 6 months post-intervention.
Secondary outcomes:
measure: Change in quality of life assessed using the Chinese version of the 12-item Short Form Health Survey version 2
timeFrame: At baseline, 3 months post-intervention , and 6 months post-intervention.
measure: Change in psychological distress assessed using the Chinese version of 21-item Depression Anxiety Stress Scale
timeFrame: At baseline, 3 months post-intervention , and 6 months post-intervention.
measure: Change in perceived loneliness assessed using the Chinese version of the UCLA 3-item Loneliness Scale
timeFrame: At baseline, 3 months post-intervention , and 6 months post-intervention.
measure: Change in functional mobility assessed using the Timed Up and Go Test
timeFrame: At baseline, 3 months post-intervention , and 6 months post-intervention.
measure: Change in sedentary behaviour assessed using the Chinese version of the Sedentary Behaviour Questionnaire for Elderly
timeFrame: At baseline, 3 months post-intervention , and 6 months post-intervention.
measure: Change in frequency of healthcare utilization assessed using the self-reported healthcare utilization survey
timeFrame: At baseline, 3 months post-intervention , and 6 months post-intervention.
measure: Participant reach and recruitment success measured by recruitment records
timeFrame: At baseline.
measure: Participant satisfaction with the intervention assessed using the Chinese version of four-dimension Client Satisfaction Questionnaire
timeFrame: At 3 months post-intervention and 6 months post-intervention.
measure: Service provider acceptability and adoption of person-centred care approach measured by focus group interview
timeFrame: At 3 months post-intervention.
measure: Implementation fidelity and adherence to person-centred care principles measured by session recordings and fidelity checklist
timeFrame: Ongoing monitoring during intervention.
measure: Long-term maintenance and retention of participants measured by cost-effectiveness analysis and retention and dropout records
timeFrame: At 6 months post-intervention.
measure: Barriers and Facilitators to the intervention measured by focus group interview
timeFrame: At 3 months post-intervention.
Other outcomes:
Locations:
Study officials:
affiliation: School of Nursing, The Hong Kong Polytechnic University
name: Prof. Arkers Wong
role: PRINCIPAL_INVESTIGATOR
References: