mHealth-supported Coach

A Multidisciplinary-led Personalised mHealth-supported Coach for Reducing Midlife Stroke Risk

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

Study Overview

• Status: Recruiting
• Conditions: Heart Disease Risk Factors
• Intervention / Treatment: Behavioral: mHealth-supported coaching; Behavioral: Conventional Health coaching

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.

• Study Type: Interventional
• Enrollment (Estimated): 164
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Helen Y Chan, Ph.D; Phone Number: +85239438099; Email: helencyl@cuhk.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong, 00000
    • Recruiting
    • The Chinese University of Hong Kong
    • Contact: Helen Chan; Phone Number: 39438099; Email: helencyl@cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 64 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Personalised mHeatlh-supported coaching programme; Three monthly individual consultation session, supported with a specific mobile application.	Behavioral: 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.
Active Comparator: Traditional in-person health coaching programme; Three monthly individual consultation sessions.	Behavioral: Conventional Health coaching; Three individual consultation sessions delivered by a nurse.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-promoting behaviours	Four subscales, including health responsibility, nutrition, physical activity and stress management, of the Health Promoting Lifestyle Profile II. The possible score range from 34 to 136, with a higher score meaning healthier lifestyles were adopted.	3-month post-allocation
Health-promoting behaviours	Four subscales, including health responsibility, nutrition, physical activity and stress management, of the Health Promoting Lifestyle Profile II. The possible score range from 34 to 136, with a higher score meaning healthier lifestyles were adopted.	6-month post-allocation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-efficacy of adopting health-promoting behaviours	The adapted version of the Diabetes Mellitus Type II Self Efficacy Scale will be used. Participants will rate their level of confidence in various behaviours, in diet control, weight control and lifestyle management, by using a five-point Likert scale. The possible scores ranged from 7 to 35, with a higher score meaning a higher level of self-efficacy.	3-month post-allocation
Self-efficacy	The adapted version of the Diabetes Mellitus Type II Self Efficacy Scale will be used. Participants will rate their level of confidence in various behaviours, in diet control, weight control and lifestyle management, by using a five-point Likert scale. The possible scores ranged from 7 to 35, with a higher score meaning a higher level of self-efficacy.	6-month post-allocation
INTERHEART risk score	The score was calculated based on the weighted sum of nine risk factors, including age, sex, lifestyles and psychosocial wellbeing, which were significantly related to cardiovasuclar diseases. The possible score range was 0 - 48, in which a higher score corresponds to higher risk.	3-month post-allocation
INTERHEART risk score	The score was calculated based on the weighted sum of nine risk factors, including age, sex, lifestyles and psychosocial wellbeing, which were significantly related to cardiovasuclar diseases. The possible score range was 0 - 48, in which a higher score corresponds to higher risk.	6-month post-allocation
automatic retinal image analysis	Retinal fundus image will be obtained from both eyes of the participant using a non-mydriatic digital retinal camera (Canon CR-2 AF, U.S.A., Inc). Stroke risk estimation will be determined through fractural analysis, statistical texture analysis and high-order spectra analysis based on the retinal vessel parameters. The ARIA-stroke algorithm developed using R and Matlab software has a sensitivity and a specificity of 94.7% and 100%, respectively. The value between 0.5 and 0.7 is considered as moderate risk, while high risk is considered at 0.7 or higher.	3-month post-allocation
automatic retinal image analysis (ARIA)	Retinal fundus image will be obtained from both eyes of the participant using a non-mydriatic digital retinal camera (Canon CR-2 AF, U.S.A., Inc). Stroke risk estimation will be determined through fractural analysis, statistical texture analysis and high-order spectra analysis based on the retinal vessel parameters. The ARIA-stroke algorithm developed using R and Matlab software has a sensitivity and a specificity of 94.7% and 100%, respectively. The value between 0.5 and 0.7 is considered as moderate risk, while high risk is considered at 0.7 or higher.	6-month post-allocation
Psychological distress	The Depression Anxiety Stress Scale (DASS-21)includes 21 items, with 7 in each subscale: depression, anxiety and stress. Participants will rate their level of agreement with the statements on a 4-point Likert scale, from 0 (not apply to me at all) to 3 (applied to me very much). The potential scores range from 0 to 63, with a higher score means higher level of distress experienced.	3-month post-allocation
Psychological distress	The Depression Anxiety Stress Scale (DASS-21)includes 21 items, with 7 in each subscale: depression, anxiety and stress. Participants will rate their level of agreement with the statements on a 4-point Likert scale, from 0 (not apply to me at all) to 3 (applied to me very much). The potential scores range from 0 to 63, with a higher score means higher level of distress experienced.	6-month post-allocation
Change in Blood pressure	Blood pressure measurement will be carried out, after 10 min of rest, on the left arm in a sitting posture by using an electronic sphygmomanometer.	Between baseline and 3-month post-allocation
Change in Blood pressure	Blood pressure measurement will be carried out, after 10 min of rest, on the left arm in a sitting posture by using an electronic sphygmomanometer.	Between 3-month and 6-month post-allocation
Change in Body mass index (BMI)	BMI will be calculated by dividing the weight (in kilogram) by the height (in meter) squared. The height will be measured using a stadiometer, and body weight will be measured using an electronic scale.	Between baseline and 3-month post-allocation
Change in Body mass index(BMI)	BMI will be calculated by dividing the weight (in kilogram) by the height (in meter) squared. The height will be measured using a stadiometer, and body weight will be measured using an electronic scale.	Between 3-month and 6-month post-allocation
Change in Waist-hip ratio (WHR)	WHR will be used for determining body fat distribution. Waist circumference will be measured at the mid-point between the lowest rib and the iliac crest, whereas hip circumference will be measured at the widest level over the great trochanters. The two measurements will be measured to the nearest 0.1 cm by using a measuring tape.	Between baseline and 3-month post-allocation
Change in Waist-hip ratio (WHR)	WHR will be used for determining body fat distribution. Waist circumference will be measured at the mid-point between the lowest rib and the iliac crest, whereas hip circumference will be measured at the widest level over the great trochanters. The two measurements will be measured to the nearest 0.1 cm by using a measuring tape.	Between 3-month and 6-month post-allocation
Change in Fasting blood glucose	Blood samples will be taken by an experienced nurse and sent to accredited commercial biochemistry laboratories for analysis.	Between baseline and 3-month post-allocation
Change in Fasting blood glucose	Blood samples will be taken by an experienced nurse and sent to accredited commercial biochemistry laboratories for analysis.	Between 3-month and 6-month post-allocation
Change in Blood lipid profile	The profile includes ncluding triglyceride, total Cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C). Blood samples will be taken by an experienced nurse and sent to accredited commercial biochemistry laboratories for analysis.	Between baseline and 3-month post-allocation
Change in Blood lipid profile	The profile includes ncluding triglyceride, total Cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C). Blood samples will be taken by an experienced nurse and sent to accredited commercial biochemistry laboratories for analysis.	Between 3-month and 6-month post-allocation

Collaborators and Investigators

• Sponsor: Food and Health Bureau, Hong Kong
• Investigators: Principal Investigator: Helen Y Chan, Ph.D, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2022
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): September 4, 2024

Study Registration Dates

• First Submitted: June 8, 2022
• First Submitted That Met QC Criteria: June 13, 2022
• First Posted (Actual): June 16, 2022

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 18, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Primary Health Care
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases
• Other Study ID Numbers: 05200218

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No