Effectiveness of an mHealth Intervention for Youth With Congenital Heart Disease

Not Applicable

Completed

• Conditions: Congenital Heart Disease; Adolescent Behavior
• Interventions: Behavioral: an mHealth intervention

• Registration Number: NCT04264650
• Lead Sponsor: National Yang Ming Chiao Tung University

Brief Summary

The aims of this study were to evaluate the long-term effectiveness of the Care \& Organize Our Lifestyle (COOL) program, a self-regulation theory-based mHealth program, on improving disease knowledge and physical activity in youth with congenital heart disease (CHD). The COOL program is a 12-month randomized controlled trial that compared two active intervention groups to a standard-care control group (n = 47). Participants with simple and moderate CHD aged 15-24 years were recruited from pediatric or adult CHD outpatient departments. Participants in one active intervention group (n = 49) were provided with COOL Passport, a mobile healthcare application. Those in the other group (n = 47) were provided with access to the Health Promotion Cloud system and use of game-based interactive platforms along with COOL Passport. Outcomes were the Leuven Knowledge Questionnaire for CHD and the International Physical Activity Questionnaire-Taiwan Show-Card Version.

Detailed Description

Background: Mobile health initiatives may provide youth with congenital heart disease (CHD) relevant health information and a platform for managing the complex health care needs associated with undergoing transitional care.

Aims: To evaluate the long-term effectiveness of the Care \& Organize Our Lifestyle (COOL) program, a self-regulation theory-based mHealth program, on improving disease knowledge and physical activity in youth with CHD.

Methods: The COOL program is a 12-month randomized controlled trial that compared two active intervention groups to a standard-care control group (n = 47). Participants with simple and moderate CHD aged 15-24 years were recruited from pediatric or adult CHD outpatient departments. Participants in one active intervention group (n = 49) were provided with COOL Passport, a mobile healthcare application. Those in the other group (n = 47) were provided with access to the Health Promotion Cloud system and use of game-based interactive platforms along with COOL Passport. Outcomes were the Leuven Knowledge Questionnaire for CHD and the International Physical Activity Questionnaire-Taiwan Show-Card Version.

Study Timeline

• Study Start: 2016-06-01
• Primary Completion: 2018-02-28
• Study Completion: 2018-02-28
• Status Verified: 2020-02
• Study First Submitted: 2020-02-09
• Study First Submitted QC: 2020-02-09
• Last Update Submitted: 2020-02-09
• Study First Posted: 2020-02-11
• Last Update Posted: 2020-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 143

Inclusion Criteria

• being diagnosed with CHD by a pediatric cardiologist and qualifying as having simple or moderate CHD complexity according to the 2008 American College of Cardiology/American Heart Association guidelines;
• having a regular pulse;
• being 15-24 years of age;
• being conversant in Mandarin and Taiwanese;
• possessing a smartphone with Internet connection;
• agreeing to wear an exercise-monitoring wristband to record physiological data;
• agreeing to engage in exercises designed to test cardiopulmonary endurance;
• agreeing to participate in the study and sign an informed consent form for a relevant interview. For participants under 20 years of age, guardian approval by signing a written consent form was required.

Exclusion Criteria

• having cognitive impairment to the extent of being noncommunicative;
• having CHD complicated with other congenital abnormalities;
• having undergone a cardiac catheter-related intervention or surgery within the past 6 months;
• being pregnant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The other active intervention group	an mHealth intervention	provided with access to the Health Promotion Cloud system and use of game-based interactive platforms along with COOL Passport
One active intervention group	an mHealth intervention	provided with COOL Passport, a mobile healthcare application

Primary Outcome Measures

Name	Time	Method
Cardiac disease knowledge	12 months	measured by the Leuven Knowledge Questionnaire for CHD

Secondary Outcome Measures

Name	Time	Method
Physical activity	12 months	measured by the International Physical Activity Questionnaire-Taiwan Show-Card Version

Trial Locations

Locations (1)

National Yang-Ming University; 🇨🇳 Taipei, Taiwan