Effects of mHealth on Promoting Self-care Health Management Among Older Adults in the Community

August 1, 2022 updated by: Arkers, Wong, The Hong Kong Polytechnic University

Effects of mHealth on Promoting Self-care Health Management Among Older Adults in the Community: A 3-arm Randomized Controlled Trial

Many of the existing mobile health (mHealth) apps designed in a reactive care approach, in which people do not receive individualized care until they consulted health care professionals through the apps. This proposal endeavors to develop a proactive mHealth application on promoting self-care ability and health among older adults to examine the differential benefits of adding nurse interaction supported by an integrated health-social partnership model in the use of mHealth.

Study Overview

Detailed Description

Objectives: Many of the existing mobile health (mHealth) apps designed in a reactive care approach, in which people do not receive individualized care until they consulted health care professionals through the apps. This proposal endeavors to develop a proactive mHealth application on promoting self-care ability and health among older adults to examine the differential benefits of adding nurse interaction supported by an integrated health-social partnership model in the use of mHealth.

Hypothesis to be tested: There is no difference in self-management outcomes, individual and societal benefits between the subjects receiving mHealth+Interactivity, mHealth, and usual care.

Design and subjects: This is a single-blinded, three-armed randomized controlled trial. The subjects are people who are aged 60 or above with chief complaints of either pain, hypertension, or diabetes mellitus.

Instruments: mHealth application designed by the research team with the information technological support by Smartone.

Interventions: mHealth with interactivity group receives both mHealth app and nurse case management supported by a social service team in community. mHealth group will have access to health content on mHealth platform only. Usual care group receives usual community services.

Main outcome measures: Self-management outcomes (self-efficacy, pain score, blood pressure, capillary blood glucose), individual (quality of life, depression) and societal benefits (institutionalization and health service utilization).

Data analysis: Generalized Estimating Equation (GEE) is used to determine the between-group effects, within-group effects, and the interaction effects.

Expected results: Older adults would benefit from supported self-care equipping them with sufficient knowledge, skills and confidence to lead to relatively independent life at home.

Study Type

Interventional

Enrollment (Actual)

221

Phase

  • 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 Locations

    • Siu Sai Wan
      • Hong Kong, Siu Sai Wan, Hong Kong, 00000
        • The Lutheran Group of social service

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

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • people who are aged 60 or above
  • with chief complaints of either pain, hypertension, or diabetes mellitus
  • living within the service areas and (4) using smartphone

Exclusion Criteria:

  • already engaged in other mHealth programs
  • diagnosed with psychiatric problems
  • bed-bound
  • living in area with no 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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mHealth+I
This group of participants will receive a proactive mHealth with interactivity program which includes two main elements: 1) mHealth application designed by the research team with the information technological support by Smartone and 2) nurse case management supported by a social service team
a mHealth device with interactivity with nurse case manager
Active Comparator: mHealth
The mHealth group will have access to the health content on the mHealth platform. This group 2018 HMRF Open Call Proposal Section 13: Proposed Research Project 5 will enjoy the same content and client-initiated help if needed. Same as the above group, the client is invited to use the mHealth application. A reminder message will pop up on the screen of smartphone when participants have not used it for more than one week. The participants are encouraged to read the self-care information that is featured in the app. There is a button for the client-imitated call if they would like to consult a nurse.
a mHealth device
No Intervention: Control
All groups will receive usual community services. The study district provides community-based health talks and basic health checks such as measuring blood pressure and blood glucose that are accessible to all residents, and their participation is voluntary. Both health and social services are available in the community for those who need help, including referral for further help if appropriate. These services are however episodic with design for continuity of care. No mHealth application will be provided to the participants in this group but the individuals are free to do their own surfing for e-health information.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life (general well-being of individual)
Time Frame: 3-month
Quality of life will be measured by SF-12v2 (physical and psychological component) version which has been translated, validated and proven reliable for use among the Hong Kong Chinese population.This questionnaire is a generic measure, as opposed to one that targets a specific age and disease. It has shown useful in Chinese elderly patients. The scale ranged from 0 to 100, with 50 indicating the standardized norm scale
3-month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
depression
Time Frame: 3-month
Depression will be measured by the Chinese version of the Geriatric Depression Scale. Good validity and reliability were reported in this scale, with criterion-related validity 0.95 and test-retest reliability 0.85 among the elderly Chinese population. The questionnaire consists of 15 questions which are used to explore the feelings of participants with the dichotomous answers. The scale has ranged from 0 to 15, higher scores indicated higher depressive severity.
3-month
self-efficacy
Time Frame: 3-month
Self-efficacy will be measured by General Self-Efficacy Scale. This scale is used to determine how people judge their ability to handle difficult situations or solve their own problems, and thus can be a way to assess the effectiveness of empowerment programs. All 10-item in the Chinese version are rated on a 4-point Likert scale ranging from 1= not at all true to 4= exactly true. Scores on the scale are summated and higher scores indicate greater self-efficacy.Measuring general self-efficacy can provide a way to evaluate the effectiveness of empowerment interventions.
3-month
pain score
Time Frame: 3-month
Pain score is measured by Visual Analog Scale that installed in the app. Pain score is ranging from 0 (no pain) to 10 (severe pain).
3-month
blood pressure
Time Frame: 3-month
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).
3-month
capillary blood glucose
Time Frame: 3-month
Capillary blood glucose level will be measured by a standard capillary glucose meter.
3-month
health service utilization
Time Frame: 3-month
Health service utilization will be measured by the number of attendance to government out-patient clinics (GOPC), and number of unscheduled visits to the emergency department and hospital admission.
3-month

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Arkers Wong, Master, The Hong Kong Polytechnic University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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)

December 1, 2020

Primary Completion (Actual)

April 30, 2022

Study Completion (Actual)

July 31, 2022

Study Registration Dates

First Submitted

March 12, 2019

First Submitted That Met QC Criteria

March 14, 2019

First Posted (Actual)

March 18, 2019

Study Record Updates

Last Update Posted (Actual)

August 3, 2022

Last Update Submitted That Met QC Criteria

August 1, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • mHSC-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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