- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03878212
Effects of mHealth on Promoting Self-care Health Management Among Older Adults in the Community
Effects of mHealth on Promoting Self-care Health Management Among Older Adults in the Community: A 3-arm Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Siu Sai Wan
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Hong Kong, Siu Sai Wan, Hong Kong, 00000
- The Lutheran Group of social service
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
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a mHealth device with interactivity with nurse case manager
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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.
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a mHealth device
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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.
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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
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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
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3-month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
depression
Time Frame: 3-month
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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.
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3-month
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self-efficacy
Time Frame: 3-month
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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.
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3-month
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pain score
Time Frame: 3-month
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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).
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3-month
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blood pressure
Time Frame: 3-month
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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).
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3-month
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capillary blood glucose
Time Frame: 3-month
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Capillary blood glucose level will be measured by a standard capillary glucose meter.
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3-month
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health service utilization
Time Frame: 3-month
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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.
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3-month
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Collaborators and Investigators
Investigators
- Principal Investigator: Arkers Wong, Master, The Hong Kong Polytechnic University
Publications and helpful links
General Publications
- Wong AKC, Wong FKY, Chow KKS, Wong SM, Bayuo J, Ho AKY. Effect of a Mobile Health Application With Nurse Support on Quality of Life Among Community-Dwelling Older Adults in Hong Kong: A Randomized Clinical Trial. JAMA Netw Open. 2022 Nov 1;5(11):e2241137. doi: 10.1001/jamanetworkopen.2022.41137.
- Wong AKC, Wong FKY, Bayuo J, Chow KKS, Wong SM, Lee AYL. A randomized controlled trial of an mHealth application with nursing interaction to promote quality of life among community-dwelling older adults. Front Psychiatry. 2022 Oct 18;13:978416. doi: 10.3389/fpsyt.2022.978416. eCollection 2022.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
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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