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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
130

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Yan Oi Tong
        • Contact:
          • Ricky Liu, MSc
          • Phone Number: +85234003805

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: PCC-based mHealth-assisted self-care support intervention
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).
Behavioral: Provider-led mHealth-assisted self-care support intervention
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
At baseline, 3 months post-intervention , and 6 months post-intervention.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
Unit of Measure: Mean score on quality of life.
At baseline, 3 months post-intervention , and 6 months post-intervention.
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.
Unit of Measure: Mean score on psychological distress.
At baseline, 3 months post-intervention , and 6 months post-intervention.
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.
Unit of Measure: Mean score on perceived loneliness.
At baseline, 3 months post-intervention , and 6 months post-intervention.
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.
Unit of Measure: Time in seconds.
At baseline, 3 months post-intervention , and 6 months post-intervention.
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.
Unit of Measure: Mean hours per day.
At baseline, 3 months post-intervention , and 6 months post-intervention.
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.
Unit of Measure: Number of visits.
At baseline, 3 months post-intervention , and 6 months post-intervention.
Participant reach and recruitment success measured by recruitment records
Time Frame: At baseline.
Unit of Measure: Percentage of eligible enrollment.
At baseline.
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.
Unit of Measure: Mean score on satisfaction.
At 3 months post-intervention and 6 months post-intervention.
Service provider acceptability and adoption of person-centred care approach measured by focus group interview
Time Frame: At 3 months post-intervention.
Unit of Measure: Thematic analysis of interview records.
At 3 months post-intervention.
Implementation fidelity and adherence to person-centred care principles measured by session recordings and fidelity checklist
Time Frame: Ongoing monitoring during intervention.
Unit of Measure: 1). Number and reasons for missed sessions; 2). Percentage of sessions meeting fidelity criteria.
Ongoing monitoring during intervention.
Long-term maintenance and retention of participants measured by cost-effectiveness analysis and retention and dropout records
Time Frame: At 6 months post-intervention.
Unit of Measure: 1). Incremental cost-effectiveness ratio (ICER) per additional quality adjusted life year (QALY) gained; 2). Number and reasons of dropout.
At 6 months post-intervention.
Barriers and Facilitators to the intervention measured by focus group interview
Time Frame: At 3 months post-intervention.
Unit of Measure: Thematic analysis of interview records.
At 3 months post-intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hong Kong Polytechnic University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 10, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 17, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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