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Clinical Trials/NCT04264650
NCT04264650
Completed
Not Applicable

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

National Yang Ming Chiao Tung University1 site in 1 country143 target enrollmentJune 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Congenital Heart Disease
Sponsor
National Yang Ming Chiao Tung University
Enrollment
143
Locations
1
Primary Endpoint
Cardiac disease knowledge
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2016
End Date
February 28, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Chi-Wen Chen

Professor

National Yang Ming Chiao Tung University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Cardiac disease knowledge

Time Frame: 12 months

measured by the Leuven Knowledge Questionnaire for CHD

Secondary Outcomes

  • Physical activity(12 months)

Study Sites (1)

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