mHealth-supported Coach

NCT ID: NCT05422729

Last Updated: 2023-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-05

Study Completion Date

2024-09-04

Brief Summary

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A randomised controlled trial to evaluate the effects of a personalised mHealth-supported coach programme in the middle-aged group with stroke risk.

Detailed Description

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Aim: To evaluate the effects of a personalised mHealth-supported coach programme on the adoption of health-promoting behaviours in the middle-aged group, in comparison with usual care.

Design: A 24-month prospective two-arm, parallel-group, single-blinded, repeated-measure randomised controlled trial will be conducted.

Participants: People who aged between 40 and 64, mentally competent, have a non-laboratory INTERHEART risk score (IHRS) of 10 or higher, communicable in Chinese and free from stroke and transient ischemic attack (TIA) or other cardiovascular disease will be eligible to the study. A total of 164 participants will be recruited through a district community centre and randomly assigned on 1:1 ratio to the intervention group or the control group.

Intervention: A theory-based mHealth-supported coach programme, including individual consultation sessions and a mobile application with a virtual sharing platform, is developed by a multidisciplinary team for the intervention group over three months, whereas the control group receives usual care.

Conditions

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Heart Disease Risk Factors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Personalised mHeatlh-supported coaching programme

Three monthly individual consultation session, supported with a specific mobile application.

Group Type EXPERIMENTAL

mHealth-supported coaching

Intervention Type BEHAVIORAL

The intervention includes two components. Three individual consultation sessions based on a health coaching protocol developed by a multidisciplinary team. A mobile application provides educational information about healthy lifestyles, knowledge quizzes, telemonitoring function and virtual platform for sharing.

Traditional in-person health coaching programme

Three monthly individual consultation sessions.

Group Type ACTIVE_COMPARATOR

Conventional Health coaching

Intervention Type BEHAVIORAL

Three individual consultation sessions delivered by a nurse.

Interventions

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mHealth-supported coaching

The intervention includes two components. Three individual consultation sessions based on a health coaching protocol developed by a multidisciplinary team. A mobile application provides educational information about healthy lifestyles, knowledge quizzes, telemonitoring function and virtual platform for sharing.

Intervention Type BEHAVIORAL

Conventional Health coaching

Three individual consultation sessions delivered by a nurse.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Chinese ethnic
* able to read Chinese and communicate in Cantonese/Mandarin
* with non-laboratory IHRS score 10 or higher

Exclusion Criteria

* mentally incompetent
* previously diagnosed with stroke, TIA, MI, coronary heart disease, heart failure or atrial fibrillation
* with eye or retinal disease
* with terminal disease with an expected life expectancy less than six months
* being pregnant
* have enrolled in other lifestyle-based or exercise-based projects
* do have mobile devices or internet service to access the mobile application
Minimum Eligible Age

40 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Food and Health Bureau, Hong Kong

OTHER_GOV

Sponsor Role lead

Responsible Party

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Dr. Helen YL Chan

Associate Professor (Dr)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Helen Y Chan, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

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The Chinese University of Hong Kong

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Helen Y Chan, Ph.D

Role: CONTACT

+85239438099

Facility Contacts

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Helen Chan

Role: primary

Other Identifiers

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05200218

Identifier Type: -

Identifier Source: org_study_id

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