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AzTrials

TelemedicineNCT03878212

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

A study testing mHealth application with interactivity and mHealth application in people with Telemedicine, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Telemedicine
What is being tested?
mHealth application with interactivity and mHealth application
Could I receive a placebo?
No, everyone receives an active treatment
How many people
221 participants
Where
1 siteHong Kong
Study dates
1 Dec 2020to 31 Jul 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • already engaged in other mHealth programs
  • diagnosed with psychiatric problems
  • bed-bound
  • living in area with no internet coverage

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

  • The Lutheran Group of social service

    Hong Kong, Siu Sai Wan, 00000

Other trials in Hong Kong

About this study

Official title: 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.

Read the 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.

Conditions
Telemedicine
Being tested
mHealth application with interactivity, mHealth application
Keywords
mHealth, app
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mHealth application with interactivityOther

    a mHealth device with interactivity with nurse case manager

  • mHealth applicationOther

    a mHealth device

Study groups in NCT03878212
Study groupRoleWhat they receive
mHealth+IExperimentalThis 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
Receives: Other: mHealth application with interactivity
mHealthActive comparatorThe 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.
Receives: Other: mHealth application
ControlNo interventionAll 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 3-month

Secondary outcomes (6)

  1. 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.

    Measured: 3-month

  2. 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.

    Measured: 3-month

  3. 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).

    Measured: 3-month

  4. 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).

    Measured: 3-month

  5. capillary blood glucose

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

    Measured: 3-month

  6. 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.

    Measured: 3-month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2019
  2. Study start1 Dec 2020
  3. Primary completion30 Apr 2022
  4. Study completion31 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
221 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03878212
Sponsor's protocol ID
mHSC-01
Status last verified
Aug 2022
First submitted
12 Mar 2019
Last updated
3 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wong AKC, Bayuo J, Wong FKY, Chow KKS, Wong SM, Lau ACK. The Synergistic Effect of Nurse Proactive Phone Calls With an mHealth App Program on Sustaining App Usage: 3-Arm Randomized Controlled Trial. J Med Internet Res. 2023 May 1;25:e43678. doi: 10.2196/43678.

    PubMed 37126378

  • 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.

    PubMed 36350651

  • 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.

    PubMed 36329920

Questions about this trial

What is this clinical trial studying?

A study testing mHealth application with interactivity and mHealth application in people with Telemedicine, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of life (general well-being of individual) (time frame: 3-month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03878212, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2022.

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