Heart Disease Risk Factors
Conditions
Keywords
Primary Health Care
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.
Interventions
BEHAVIORALmHealth-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.
BEHAVIORALConventional Health coaching
Three individual consultation sessions delivered by a nurse.
Sponsors
Food and Health Bureau, Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Health-promoting behaviours | 3-month post-allocation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-efficacy | 6-month post-allocation | 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. |
| INTERHEART risk score | 3-month post-allocation | 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. |
| automatic retinal image analysis | 3-month post-allocation | 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. |
| automatic retinal image analysis (ARIA) | 6-month post-allocation | 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. |
| Psychological distress | 3-month post-allocation | 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. |
| Self-efficacy of adopting health-promoting behaviours | 3-month post-allocation | 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. |
| Change in Body mass index (BMI) | Between baseline and 3-month post-allocation | 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. |
| Change in Body mass index(BMI) | Between 3-month and 6-month post-allocation | 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. |
| Change in Waist-hip ratio (WHR) | Between baseline and 3-month post-allocation | 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. |
| Change in Fasting blood glucose | Between baseline and 3-month post-allocation | Blood samples will be taken by an experienced nurse and sent to accredited commercial biochemistry laboratories for analysis. |
| Change in Blood lipid profile | Between baseline and 3-month post-allocation | 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. |
| Change in Blood pressure | Between baseline and 3-month post-allocation | 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. |
Countries
Hong Kong
Contacts
Primary ContactHelen Y Chan, Ph.D
Outcome results
None listed