Effectiveness of an mHealth Intervention for Youth With Congenital Heart Disease

Congenital Heart Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04264650
• Other study ID #: 201603045RINA
• Status: Completed
• Phase: N/A
• Start date: June 1, 2016
• Est. completion date: February 28, 2018

Study information

• Verified date: February 2020
• Source: National Yang Ming University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: February 28, 2018
• Est. primary completion date: February 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Behavior
• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

Behavioral:
• an mHealth intervention
The Care & Organize Our Lifestyle (COOL) program, a self-regulation theory-based mHealth program

Locations

Country	Name	City	State
Taiwan	National Yang-Ming University	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Yang Ming University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac disease knowledge	measured by the Leuven Knowledge Questionnaire for CHD	12 months
Secondary	Physical activity	measured by the International Physical Activity Questionnaire—Taiwan Show-Card Version	12 months