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

Telemedicine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03878212
• Other study ID #: mHSC-01
• Status: Completed
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: July 31, 2022

Study information

• Verified date: August 2022
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 221
• Est. completion date: July 31, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Telemedicine

Intervention

Other:
• mHealth application with interactivity
a mHealth device with interactivity with nurse case manager
• mHealth application
a mHealth device

Locations

Country	Name	City	State
Hong Kong	The Lutheran Group of social service	Hong Kong	Siu Sai Wan

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life (general well-being of individual)	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	depression	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
Secondary	self-efficacy	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
Secondary	pain score	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
Secondary	blood pressure	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
Secondary	capillary blood glucose	Capillary blood glucose level will be measured by a standard capillary glucose meter.	3-month
Secondary	health service utilization	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