- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07691398
An mHealth-based Healthcare Professional-Lay Health Worker Partnership Program (mHLPP)
A Feasibility Study of an mHealth-based Healthcare Professional-Lay Health Worker Partnership Program (mHLPP) Among Community-dwelling Impoverished Older Adults
The project aimed at training female food delivery workers from Food Angel to perform basic health checks for older adults living alone in the community.
After undergoing training, the female delivery workers will be equipped with basic health knowledge and the ability to measure physical vital signs, including blood oxygen levels, blood pressure, and pulse and pain indices, for around 100 older adults when they visit them to deliver meals. The health data collected by the delivery workers will be uploaded to the mHealth monitoring platform developed by Prof. Arkers Wong's research team. Registered nurses (RNs) will be given access to the platform to evaluate the health status of the older adults. When needed, an RN will give in-depth personal care and interventions via the mHealth app to the older adults. Referrals to allied health professionals or social workers can also be made by the RNs for early interventions.
The team hope that this first-of-its-kind grassroots community health model, undertaken in combination with the Health-Social Partnership, will provide scientific research evidence for the Hong Kong government to consider introducing the mHealth app and the service model to the community as a way to strengthen primary healthcare.
The mHealth app is a pilot health management mobile app with an interactive nurse support function. The app enables nurses to monitor the health status of users and allow users to communicate with nurses when they have health concerns. Research findings released by the team in March 2023 showed that older adults' use of the app for 3 to 6 months resulted in a significant increase in self-efficacy, a significant decrease in depression levels, a reduction in the use of medical services, and an improvement in quality of life.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Hong Kong
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Hong Kong, Hong Kong, Hong Kong, 999077
- Food Angel
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- age 60 or over
- member of the NGO (implying that they are not receiving any Government subsidize and their monthly income is less than HKD$ 6,050)
- living within the service area of the NGO
- able to sign an informed consent.
Exclusion Criteria:
- being diagnosed with dementia
- inability to communicate
- being bed-bound
- having an active psychiatric illness with recent hospital admission within the last six months
- being already engaged in other mHealth studies.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: mHealth-based Healthcare professional-Lay health worker Partnership Program (mHLPP)
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The participants are able to receive the services offered by this program.
During the six-month program, the lay health workers deliver the free meal provided by Food Angel at the participants' home and measure the participants' vital signs including blood pressure, pulse, oxygen saturation, and pain level (if any), and they upload the results to the mHealth app subsequently.
During the 6-month program, the participants receive eleven home visits from a nurse.
During the first month, the nurse visit the participants weekly.
The nurse visit the participants twice a week for two and three months.
The nurse only visit the participants once a month between the fourth and sixth month.
The nurse conduct a comprehensive health assessment and establish some health goals with the participants during the home visit.
She formulate an individual care plan, and record them on the app for the lay health worker to follow-up.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility of the program implementation: implementation facilitators/barriers and acceptability
Time Frame: At 6 months (T3) after baseline.
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Three separated semi-structured group interviews with healthcare professionals, lay health workers, and older adults will be conducted to explore their views on facilitating, hindering factors, and the acceptability of implementing the program in the community at six months.
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At 6 months (T3) after baseline.
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Feasibility of the program implementation: safety
Time Frame: At 6 months (T3) after baseline.
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Incidence of report of adverse events that is encountered by the older adults, lay health workers, and healthcare professionals will be measured to assess the safety of the program.
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At 6 months (T3) after baseline.
|
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Feasibility of the program implementation: fidelity
Time Frame: At 6 months (T3) after baseline.
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A performance checklist that developed by the research team according to the workflow of the program will be used to identify whether the program is implemented as intended.
The principal investigator of the research team will pay random quality assurance visits to evaluate whether the provided interventions are adhered to the planned content, duration, and frequency of the contact sessions.
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At 6 months (T3) after baseline.
|
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Feasibility of the study methods: program reach
Time Frame: At 6 months (T3) after baseline.
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The number of older adults and lay health workers who are eligible, invited, excluded, and enrolled to participate in the program will be counted and compared to non-participants on key demographic data such as age, sociodemographic background, and living area.
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At 6 months (T3) after baseline.
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Feasibility of the study methods: feasibility of recruitment procedures and eligibility criteria
Time Frame: At 6 months (T3) after baseline.
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The project manager of the study will be asked about the feasibility of the recruitment procedures, and the appropriateness of the eligibility criteria.
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At 6 months (T3) after baseline.
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Feasibility of the study methods: feasibility of data collection and analysis method
Time Frame: At 6 months (T3) after baseline.
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The research assistants will provide feedback on the length, clarity and acceptability of focus group interview questions and quantitative questionnaires, and ease of collecting data.
The principal investigator of the research team will and review the results from the focus groups interviews for indications of important issues relating to data collection or analysis.
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At 6 months (T3) after baseline.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Preliminary effectiveness on older adults: Blood pressure
Time Frame: Baseline assessments (T1), 3 months (T2) and 6 months (T3) after baseline.
|
Blood pressure measurement will be performed after 10 minutes of sitting rest.
A standard electronic sphygmomanometer will be used to measure supine blood pressure on the right arm of each candidate (unless contraindicated).
The results on blood pressure will be divided into systolic and diastolic blood pressure.
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Baseline assessments (T1), 3 months (T2) and 6 months (T3) after baseline.
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Preliminary effectiveness on older adults: HbA1c
Time Frame: Baseline assessments (T1), 3 months (T2) and 6 months (T3) after baseline.
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HbA1c is a standard assessment of glycemia and refers to the mean blood glucose levels over the previous 2 to 3 months.
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Baseline assessments (T1), 3 months (T2) and 6 months (T3) after baseline.
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Preliminary effectiveness on older adults: fasting lipid
Time Frame: Baseline assessments (T1), 3 months (T2) and 6 months (T3) after baseline.
|
Fasting lipid profile includes cholesterol level, and high- and low-density lipoprotein.
Both HbA1c and the fasting lipid profile will be drawn from participants' blood from their fingers at the third and sixth month when nurses have the home visits.
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Baseline assessments (T1), 3 months (T2) and 6 months (T3) after baseline.
|
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Preliminary effectiveness on older adults: body mass index (BMI)
Time Frame: Baseline assessments (T1), 3 months (T2) and 6 months (T3) after baseline.
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BMI results from dividing a subject's weight in kilograms by the square of their height in meters.
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Baseline assessments (T1), 3 months (T2) and 6 months (T3) after baseline.
|
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Preliminary effectiveness on older adults: quality of life
Time Frame: Baseline assessments (T1), 3 months (T2) and 6 months (T3) after baseline.
|
Quality of life will be measured by the version 2 of the 12-item Short Form Health Survey.
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Baseline assessments (T1), 3 months (T2) and 6 months (T3) after baseline.
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Preliminary effectiveness on older adults: perceived social support
Time Frame: Baseline assessments (T1), 3 months (T2) and 6 months (T3) after baseline.
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Perceived social support will be evaluated using the 32-item Chinese version of the Perceived Social Support Scale for Older Adults.
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Baseline assessments (T1), 3 months (T2) and 6 months (T3) after baseline.
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Preliminary effectiveness on older adults: self-care ability
Time Frame: Baseline assessments (T1), 3 months (T2) and 6 months (T3) after baseline.
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Self-care ability will be measured by the Chinese version of the Self-care Ability Scale for the Elderly (SASE).
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Baseline assessments (T1), 3 months (T2) and 6 months (T3) after baseline.
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Preliminary effectiveness on older adults: client empowerment
Time Frame: Baseline assessments (T1), 3 months (T2) and 6 months (T3) after baseline.
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Client empowerment will be evaluated by the Chinese version of the Client Empowerment Scale (CCES).
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Baseline assessments (T1), 3 months (T2) and 6 months (T3) after baseline.
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Preliminary effectiveness on older adults: health service utilization
Time Frame: Baseline assessments (T1), 3 months (T2) and 6 months (T3) after baseline.
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The outcomes of health services utilization include the total number of unscheduled visits to general out-patient departments, general practitioners (GP), emergency departments, and hospitals, and the total health service attendance.
The information will be relied on the appointment letter and the report from the subjects.
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Baseline assessments (T1), 3 months (T2) and 6 months (T3) after baseline.
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Collaborators and Investigators
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Z-JNT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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