Effectiveness of an mHealth Intervention for Youth With Congenital Heart Disease

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

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.

Study Overview

• Status: Completed
• Conditions: Congenital Heart Disease; Adolescent Behavior
• Intervention / Treatment: Behavioral: an mHealth intervention

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 Type: Interventional
• Enrollment (Actual): 143
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 11221
    • National Yang-Ming University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 24 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control group; Standard care
EXPERIMENTAL: One active intervention group; provided with COOL Passport, a mobile healthcare application	Behavioral: an mHealth intervention; The Care & Organize Our Lifestyle (COOL) program, a self-regulation theory-based mHealth program
EXPERIMENTAL: The other active intervention group; provided with access to the Health Promotion Cloud system and use of game-based interactive platforms along with COOL Passport	Behavioral: an mHealth intervention; The Care & Organize Our Lifestyle (COOL) program, a self-regulation theory-based mHealth program

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National Yang Ming University
• Investigators: Principal Investigator: Chi-Wen Chen, PhD, National Yang Ming University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2016
• Primary Completion (ACTUAL): February 28, 2018
• Study Completion (ACTUAL): February 28, 2018

Study Registration Dates

• First Submitted: February 9, 2020
• First Submitted That Met QC Criteria: February 9, 2020
• First Posted (ACTUAL): February 11, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 11, 2020
• Last Update Submitted That Met QC Criteria: February 9, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: 201603045RINA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No