CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 160 enrolled
Drug / intervention
"Care4Heart" programmebehavioral
Likely dose
Not stated in record
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Search/NCT03744650
NCT03744650N/ACompleted

Improving Awareness, Knowledge and Heart-related Lifestyle of Coronary Heart Disease Among Working Population Through a mHealth Programme

National University of Singapore·interventional·Posted Nov 16, 2018·Updated Nov 20, 2018

In Brief

A clinical study evaluating "Care4Heart" programme for CHD - Coronary Heart Disease and 2 related conditions. Completed, enrolled 160 participants.

Detailed Summary

Background: Coronary heart disease (CHD), the most prevalent type of cardiovascular disease among adults, has been identified as one of the chronic diseases which are epidemic in the world. Teaching and encouraging the working population to adopt a healthier lifestyle could favor in preventing and/or decreasing the incidence of CHD among this population. The use of mobile application (app) is the next logical wave of healthcare support tools to prevent and manage chronic diseases like CHD. Aims: The aims of the study are to develop a mHealth programme, entitled "Care4Heart" for the working population in Singapore, and thereafter examine its feasibility and effectiveness in increasing the awareness and knowledge of coronary heart disease (CHD) as well as improving their heart-related lifestyle. Methods: A two-phase study design will be adopted. Phase 1 is a pilot, two-arm randomized controlled trial (RCT) study and phase 2 is a single group pretest and repeated posttest longitudinal study. The study will be conducted in National University of Singapore. A convenience sampling will be used, and a total of 240 healthy working adults will be recruited via posters advertising in campus canteens, which comprising 80 participants in Phase 1 and 160 participants in Phase 2 study. The first recruited 80 participants will be randomly allocated to an intervention group and a control group, and only those in the intervention group will receive 4-week "Care4Heart" programme. For the participants recruited in phase 2 (n = 160), the newly developed mobile app will be installed onto their' smartphones, and a well-trained research assistant will brief the participants about the utilization of the app. The main outcomes will be measured using the survey questionnaires: Awareness of CHD, Heart Disease Fact Questionnaire-2, Behavioral Risk Factor Surveillance System and Perceived Stress Scale. Data will be collected at baseline, and at the 4th week for phase 1 study while a third data collection at the 6th month thereafter will be conducted for phase 2 participants. Data will be analyzed using IBM SPSS 22.0. Applications: If this project is proved to be feasible and effective, "Care4Heart" app, a novel CHD prevention programme will be popularized nationwide to promote knowledge and elicit positive heart-related behavioral changes for the working population in Singapore

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
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Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 16, 2018
Enrollment StartNov 1, 2014
Primary CompletionApr 30, 2017
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 7.6 years ago

Interventions

"Care4Heart" programmebehavioral

A 4-week mHealth programme in the form of a smartphone app, named "Care4Heart", has been developed. The content and scope of the design are developed by a thorough literature review and an extensive analysis of existing education leaflets and brochures used to prevent CHD. The contents are specified and tailored to the working population. The app is developed by a team of software engineers from Computing School of NUS. Several functions include: (1) app using instructional video; (2) easy-to-read information on healthy lifestyle toward heart health, including information about the disease, CHD risk factors (e.g. diet, smoking cessation), stress, physical exercises and relaxation techniques; and (3) scheduled reminders for doing exercise and relaxation