NCT07691398

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
230

participants targeted

Target at P75+ for not_applicable

Timeline
29mo left

Started Apr 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress50%
Apr 2024Nov 2028

Study Start

First participant enrolled

April 5, 2024

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

June 29, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 8, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2028

Last Updated

July 8, 2026

Status Verified

June 1, 2026

Enrollment Period

2.7 years

First QC Date

June 29, 2026

Last Update Submit

July 2, 2026

Conditions

Outcome Measures

Primary Outcomes (6)

  • Feasibility of the program implementation: implementation facilitators/barriers and acceptability

    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.

    At 6 months (T3) after baseline.

  • Feasibility of the program implementation: safety

    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.

    At 6 months (T3) after baseline.

  • Feasibility of the program implementation: fidelity

    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.

    At 6 months (T3) after baseline.

  • Feasibility of the study methods: program reach

    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.

    At 6 months (T3) after baseline.

  • Feasibility of the study methods: feasibility of recruitment procedures and eligibility criteria

    The project manager of the study will be asked about the feasibility of the recruitment procedures, and the appropriateness of the eligibility criteria.

    At 6 months (T3) after baseline.

  • Feasibility of the study methods: feasibility of data collection and analysis method

    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.

    At 6 months (T3) after baseline.

Secondary Outcomes (9)

  • Preliminary effectiveness on older adults: Blood pressure

    Baseline assessments (T1), 3 months (T2) and 6 months (T3) after baseline.

  • Preliminary effectiveness on older adults: HbA1c

    Baseline assessments (T1), 3 months (T2) and 6 months (T3) after baseline.

  • Preliminary effectiveness on older adults: fasting lipid

    Baseline assessments (T1), 3 months (T2) and 6 months (T3) after baseline.

  • Preliminary effectiveness on older adults: body mass index (BMI)

    Baseline assessments (T1), 3 months (T2) and 6 months (T3) after baseline.

  • Preliminary effectiveness on older adults: quality of life

    Baseline assessments (T1), 3 months (T2) and 6 months (T3) after baseline.

  • +4 more secondary outcomes

Study Arms (1)

mHealth-based Healthcare professional-Lay health worker Partnership Program (mHLPP)

EXPERIMENTAL
Other: mHealth-Based Healthcare Professional-Lay Health Worker Partnership Program (mHLPP)

Interventions

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.

mHealth-based Healthcare professional-Lay health worker Partnership Program (mHLPP)

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Food Angel

Hong Kong, Hong Kong, 999077, Hong Kong

Location

Related Publications (1)

  • Wong AKC, Liu T, Liu LZ, Bayuo J, Tao X, Wong FKY. Healthcare and Social Needs of Older Adults in Underserved Urban Communities: Insights from Community Health Workers. J Urban Health. 2025 Oct;102(5):1057-1068. doi: 10.1007/s11524-025-01011-9.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 29, 2026

First Posted

July 8, 2026

Study Start

April 5, 2024

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

November 30, 2028

Last Updated

July 8, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations