Effectiveness of an mHealth Intervention for Youth With Congenital Heart Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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Long-term Effectiveness of an mHealth Intervention for Improving the Disease Knowledge and Physical Activity of Youth With Congenital Heart Disease: A Randomized Controlled Trial

Conditions
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Congenital Heart Disease, Adolescent Behavior

Intervention / Treatment
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* Behavioral: an mHealth intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Standard care | |
| Experimental: One active intervention group<br>provided with COOL Passport, a mobile healthcare application | Behavioral: an mHealth intervention<br>* The Care & Organize Our Lifestyle (COOL) program, a self-regulation theory-based mHealth program<br>|
| Experimental: The other active intervention group<br>provided with access to the Health Promotion Cloud system and use of game-based interactive platforms along with COOL Passport | Behavioral: an mHealth intervention<br>* The Care & Organize Our Lifestyle (COOL) program, a self-regulation theory-based mHealth program<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac disease knowledge | measured by the Leuven Knowledge Questionnaire for CHD | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity | measured by the International Physical Activity Questionnaire-Taiwan Show-Card Version | 12 months |