Clinical trial NCT04264650: Effectiveness of an mHealth Intervention for Youth With Congenital Heart Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Heart Disease
Adolescent Behavior
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2020-02-11
Enrollment: 143
Sex: ALL
Minimum age (years): 15
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Cardiac disease knowledge
timeFrame: 12 months
Secondary outcomes:
measure: Physical activity
timeFrame: 12 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Yang-Ming University
Study officials:
affiliation: National Yang Ming Chiao Tung University
name: Chi-Wen Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lin PJ, Fanjiang YY, Wang JK, Lu CW, Lin KC, Cheong IM, Pan KY, Chen CW. Long-term effectiveness of an mHealth-tailored physical activity intervention in youth with congenital heart disease: A randomized controlled trial. J Adv Nurs. 2021 Aug;77(8):3494-3506. doi: 10.1111/jan.14924. Epub 2021 Jun 21.
citation: Williams CA, Wadey C, Pieles G, Stuart G, Taylor RS, Long L. Physical activity interventions for people with congenital heart disease. Cochrane Database Syst Rev. 2020 Oct 28;10(10):CD013400. doi: 10.1002/14651858.CD013400.pub2.