Clinical trial NCT05422729: mHealth-supported Coach
Official title: A Multidisciplinary-led Personalised mHealth-supported Coach for Reducing Midlife Stroke Risk
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Disease Risk Factors
Keywords: Primary Health Care
Lead sponsor: Food and Health Bureau, Hong Kong
Sponsor class: OTHER_GOV
First posted: 2022-06-16
Enrollment: 164
Sex: ALL
Minimum age (years): 40
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Health-promoting behaviours
timeFrame: 3-month post-allocation
measure: Health-promoting behaviours
timeFrame: 6-month post-allocation
Secondary outcomes:
measure: Self-efficacy of adopting health-promoting behaviours
timeFrame: 3-month post-allocation
measure: Self-efficacy
timeFrame: 6-month post-allocation
measure: INTERHEART risk score
timeFrame: 3-month post-allocation
measure: INTERHEART risk score
timeFrame: 6-month post-allocation
measure: automatic retinal image analysis
timeFrame: 3-month post-allocation
measure: automatic retinal image analysis (ARIA)
timeFrame: 6-month post-allocation
measure: Psychological distress
timeFrame: 3-month post-allocation
measure: Psychological distress
timeFrame: 6-month post-allocation
measure: Change in Blood pressure
timeFrame: Between baseline and 3-month post-allocation
measure: Change in Blood pressure
timeFrame: Between 3-month and 6-month post-allocation
measure: Change in Body mass index (BMI)
timeFrame: Between baseline and 3-month post-allocation
measure: Change in Body mass index(BMI)
timeFrame: Between 3-month and 6-month post-allocation
measure: Change in Waist-hip ratio (WHR)
timeFrame: Between baseline and 3-month post-allocation
measure: Change in Waist-hip ratio (WHR)
timeFrame: Between 3-month and 6-month post-allocation
measure: Change in Fasting blood glucose
timeFrame: Between baseline and 3-month post-allocation
measure: Change in Fasting blood glucose
timeFrame: Between 3-month and 6-month post-allocation
measure: Change in Blood lipid profile
timeFrame: Between baseline and 3-month post-allocation
measure: Change in Blood lipid profile
timeFrame: Between 3-month and 6-month post-allocation
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Helen Y Chan, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: