mHealth Lifestyle Intervention on CHD Primary Prevention

NCT03744650 | Completed DMC

• 1 other identifier: B-15-059
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

CHD - Coronary Heart Disease; Health Knowledge, Attitudes, Practice; Health Behavior

Keywords

Pirmary prevention; Coronary Heart Disease; mHealth

Outcome Measures

Primary Outcomes (3)

• Awareness of Coronary Heart Disease

  Questions that assess participants' awareness of CHD in Singapore will be developed based on the statistic facts of CHD in Singapore, for example: (1) the percentage of deaths by CHD in Singapore; and (2) the second leading cause of death in Singapore

  baseline

• Awareness of Coronary Heart Disease

  Questions that assess participants' awareness of CHD in Singapore will be developed based on the statistic facts of CHD in Singapore, for example: (1) the percentage of deaths by CHD in Singapore; and (2) the second leading cause of death in Singapore

  4th week from the baseline

• Awareness of Coronary Heart Disease

  Questions that assess participants' awareness of CHD in Singapore will be developed based on the statistic facts of CHD in Singapore, for example: (1) the percentage of deaths by CHD in Singapore; and (2) the second leading cause of death in Singapore

  6th months from the baseline

Secondary Outcomes (9)

• Heart Disease Fact Questionnaire-2 (HDFQ-2)

  baseline

• Heart Disease Fact Questionnaire-2 (HDFQ-2)

  4th week from the baseline

• Heart Disease Fact Questionnaire-2 (HDFQ-2)

  6th months from the baseline

• Behavioral Risk Factor Surveillance System (BRFSS) Questionnaire

  baseline

• Behavioral Risk Factor Surveillance System (BRFSS) Questionnaire

  4th week from the baseline

Other Outcomes (9)

• Age

  Baseline

• Gender

  Baseline

• Marital Status

  Baseline

Study Arms (1)

"Care4Heart" programme

EXPERIMENTAL

The single group pretest and repeated posttest longitudinal study design is adopted in the main study. All the recruited participants received the study intervention

Behavioral: "Care4Heart" programme

Interventions

"Care4Heart" programme BEHAVIORAL

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

"Care4Heart" programme

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• working full-time;
• aged between 21-65 years;
• use a smartphone (e.g. Samsung, iPhone) in their daily lives frequently; and
• able to read, speak and understand English.

You may not qualify if:

• have a clinical diagnosis of CHD or other heart diseases (e.g. congestive heart failure);
• work in a health-relevant school/department/environment (e.g. school of medicine, school of public health, department of dentistry, school of pharmacy; university health centre); and
• have reading difficulties.

Sponsors & Collaborators

• National University of Singapore: lead

Related Publications (24)

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  PMID: 24185949 BACKGROUND

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  PMID: 24166575 BACKGROUND

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  BACKGROUND

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  BACKGROUND

• Centres of Disease Control and Prevention (2013). Behavioural Risk Factors Surveillance System Questionnaire. Retrieved from http://www.cdc.gov/brfss. Oct. 2013.

  BACKGROUND

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  BACKGROUND

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  BACKGROUND

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  BACKGROUND

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  BACKGROUND

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  PMID: 22053522 BACKGROUND

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  PMID: 22169081 BACKGROUND

• Singapore Heart Foundation (2011). Deaths from Cardiovascular Disease. Retrieved from http://www.myheart.org.sg/heart-facts/statistics/ Oct. 2011.

  BACKGROUND

• Singapore Heart Foundation (2014). Heart4Life Phase 1. Retrieved from http://www.myheart.org.sg/article/heart-safe-singapore/heart4life-mobile-app/about/186/ January 2014.

  BACKGROUND

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  BACKGROUND

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  PMID: 15950840 BACKGROUND

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  BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Behavior; Health Behavior; Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Wenru Wang, PhD

  National University of Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: A/Prof

Model Details: 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.

Study Record Dates

• First Submitted: November 13, 2018
• First Posted: November 16, 2018
• Study Start: November 1, 2014
• Primary Completion: April 30, 2017
• Study Completion: April 30, 2017
• Last Updated: November 20, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share