Mobile HealthNCT06879457
mHealth Person-centred Self-care Support for Homebound Older Adults: A Hybrid Effectiveness-implementation Study
A study testing PCC-based mHealth-assisted self-care support intervention and Provider-led mHealth-assisted self-care support intervention in people with Mobile Health and Person-Centred Care, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Mobile Health, Person-Centred Care, Self-Care
- What is being tested?
- PCC-based mHealth-assisted self-care support intervention and Provider-led mHealth-assisted self-care support intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteHong Kong
- Study dates
- 10 Mar 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Unable to hear, see, or communicate effectively;
- Be completely bed-bound; or
- Reside in an area without stable internet coverage.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Yan Oi Tong
Hong Kong
Ricky Liu, MSc, +85234003805
About this study
Official title: 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).
Read the 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.
- Conditions
- Mobile Health, Person-Centred Care, Self-Care, Homebound, Older Adults
- Being tested
- PCC-based mHealth-assisted self-care support intervention, Provider-led mHealth-assisted self-care support intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCC-based mHealth-assisted self-care support interventionBehavioural
Participants receive six bi-weekly WhatsApp video call sessions with a NCM over three months, using a person-centred care (PCC) approach.
Provider-led mHealth-assisted self-care support interventionBehavioural
Participants receive six bi-weekly WhatsApp video call sessions with a NCM over three months, based on the conventional provider-led model.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The intervention group emphasizes shared decision-making, goal-setting, and interdisciplinary support. The NCM will co-develop self-care plans with participants. Receives: Behavioral: PCC-based mHealth-assisted self-care support intervention |
| Control Group | Active comparator | 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). Receives: Behavioral: Provider-led mHealth-assisted self-care support intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self-efficacy assessed using the Chinese version of the General Self-Efficacy Scale
Unit of Measure: Mean score on self-efficacy.
Measured: 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
Unit of Measure: Mean score on instrumental activities of daily living.
Measured: At baseline, 3 months post-intervention , and 6 months post-intervention.
Secondary outcomes (12)
Change in quality of life assessed using the Chinese version of the 12-item Short Form Health Survey version 2
Unit of Measure: Mean score on quality of life.
Measured: 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
Unit of Measure: Mean score on psychological distress.
Measured: 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
Unit of Measure: Mean score on perceived loneliness.
Measured: At baseline, 3 months post-intervention , and 6 months post-intervention.
Change in functional mobility assessed using the Timed Up and Go Test
Unit of Measure: Time in seconds.
Measured: 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
Unit of Measure: Mean hours per day.
Measured: 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
Unit of Measure: Number of visits.
Measured: At baseline, 3 months post-intervention , and 6 months post-intervention.
Participant reach and recruitment success measured by recruitment records
Unit of Measure: Percentage of eligible enrollment.
Measured: At baseline.
Participant satisfaction with the intervention assessed using the Chinese version of four-dimension Client Satisfaction Questionnaire
Unit of Measure: Mean score on satisfaction.
Measured: 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
Unit of Measure: Thematic analysis of interview records.
Measured: At 3 months post-intervention.
Implementation fidelity and adherence to person-centred care principles measured by session recordings and fidelity checklist
Unit of Measure: 1). Number and reasons for missed sessions; 2). Percentage of sessions meeting fidelity criteria.
Measured: Ongoing monitoring during intervention.
Long-term maintenance and retention of participants measured by cost-effectiveness analysis and retention and dropout records
Unit of Measure: 1). Incremental cost-effectiveness ratio (ICER) per additional quality adjusted life year (QALY) gained; 2). Number and reasons of dropout.
Measured: At 6 months post-intervention.
Barriers and Facilitators to the intervention measured by focus group interview
Unit of Measure: Thematic analysis of interview records.
Measured: At 3 months post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start10 Mar 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mobile HealthStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arkers, Wong, The Hong Kong Polytechnic University
- Investigators
- Prof. Arkers Wong, Principal investigator, School of Nursing, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06879457
- Sponsor's protocol ID
- HSEARS20240718004
- Status last verified
- Sep 2025
- First submitted
- 10 Mar 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wong AKC, Wong FKY, Ng SSM, Wong MCS, Wolf A, Cheng ASK, Wu K, Choi NG, Lee PH, Kwan RYC, Liu R, Leung YP, Choi SY. Homebound older adults in self-care using a mobile health-assisted, person-centred care approach: study protocol for a hybrid effectiveness-implementation design. BMC Prim Care. 2026 Mar 29;27(1):181. doi: 10.1186/s12875-026-03287-5.
PubMed 41904377
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empowering Homebound Older Adults in Self-care Using a Mobile Health-assisted, Person-centred Care Approach: A Hybrid Effectiveness-implementation Design
- ClinicalTrials.gov ID
- NCT06879457
- Acronym / sponsor ID
- HSEARS20240718004
- Conditions
- Mobile Health, Person-Centred Care, Self-Care, Homebound, Older Adults
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: PCC-based mHealth-assisted self-care support interventionThe intervention group emphasizes shared decision-making, goal-setting, and interdisciplinary support. The NCM will co-develop self-care plans with participants. |
| Control Group | Active comparator | Behavioral: Provider-led mHealth-assisted self-care support interventionThe 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). |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Unable to hear, see, or communicate effectively;
- Be completely bed-bound; or
- Reside in an area without stable internet coverage.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCC-based mHealth-assisted self-care support interventionParticipants receive six bi-weekly WhatsApp video call sessions with a NCM over three months, using a person-centred care (PCC) approach. | Behavioural | Intervention Group |
| Provider-led mHealth-assisted self-care support interventionParticipants receive six bi-weekly WhatsApp video call sessions with a NCM over three months, based on the conventional provider-led model. | Behavioural | Control Group |
Primary outcome
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.
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.
12 secondary outcomes
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.
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.
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.
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.
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.
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.
Participant reach and recruitment success measured by recruitment records
Time frame: 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.
Service provider acceptability and adoption of person-centred care approach measured by focus group interview
Time frame: 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.
Long-term maintenance and retention of participants measured by cost-effectiveness analysis and retention and dropout records
Time frame: At 6 months post-intervention.
Barriers and Facilitators to the intervention measured by focus group interview
Time frame: At 3 months post-intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Derived from this study: PubMed 41904377Wong AKC, Wong FKY, Ng SSM, Wong MCS, Wolf A, Cheng ASK, Wu K, Choi NG, Lee PH, Kwan RYC, Liu R, Leung YP, Choi SY. Homebound older adults in self-care using a mobile health-assisted, person-centred care approach: study protocol for a hybrid effectiveness-implementation design. BMC Prim Care. 2026 Mar 29;27(1):181. doi: 10.1186/s12875-026-03287-5.
Related trials for Mobile Health
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Effects of Clinic Versus mHealth Application-Based Shoulder Rehabilitation in Patients With Adhesive Capsulitis
Adhesive Capsulitis
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruiting
Mobile Game-Based Versus Classic First Aid Education in Adolescents: Randomized Controlled Trial
First Aid, Health Education in Schoolchildren
Not yet recruiting
Testing a Smartphone App to Support a Mediterranean Diet and Strength Exercise
Treatment Adherence and Compliance, Resistance Exercise
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Prof. Arkers Wong principal investigator
School of Nursing, The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PCC-based mHealth-assisted self-care support intervention and Provider-led mHealth-assisted self-care support intervention in people with Mobile Health and Person-Centred Care, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prof. Arkers Wong (+852 3400 3805, arkers.wong@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06879457, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.