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Completed

NCT Number: NCT03878212

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

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.

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Key information

Conditions

Telemedicine Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Lutheran Group of social service

Hong Kong, Siu Sai Wan, 00000

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mHealth application with interactivity

Other

a mHealth device with interactivity with nurse case manager

mHealth application

Other

a mHealth device

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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. 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).

  4. 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).

  5. capillary blood glucose

    Time frame: 3-month

    Capillary blood glucose level will be measured by a standard capillary glucose meter.

  6. 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.

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 18, 2019
Registry last updated
Aug 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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