CompletedNCT04264650Updated Feb 11, 2020

Effectiveness of an mHealth Intervention for Youth With Congenital Heart Disease

An interventional study of an mHealth intervention in Congenital Heart Disease and Adolescent Behavior, sponsored by National Yang Ming Chiao Tung University. Completed at 1 site in Taiwan. Open to participants aged 15 Years to 24 Years. Per ClinicalTrials.gov, last updated 2020-02-11.

Sponsored by National Yang Ming Chiao Tung University · Not applicable, Interventional, and Health services research

From the registry’s dates

Registered 3 years 8 months after the study started (first participant enrolled Jun 2016, registered Feb 2020).

Phase: Not applicable
Study type: Interventional
Enrollment: 143
Allocation: Randomized
Ages: 15 Years to 24 Years
Sex: All

Study 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.

Read the 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.

Conditions studied

Congenital Heart Disease
Adolescent Behavior

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In context

Heart Diseases

3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's enrollment of 143 is above the median of 100 across 1,778 interventional studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

National Yang Ming Chiao Tung University is the lead sponsor of 201 studies on the registry; 58 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 15 Years to 24 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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 design

Phase: Not applicable
Primary purpose: Health services research
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Participant)
Enrollment: 143 participants (actual)

Study arms

No intervention
Control group
Standard care
Experimental
One active intervention group
provided with COOL Passport, a mobile healthcare application
Behavioral: an mHealth intervention
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

Interventions

Behavioralan mHealth intervention
The Care \& Organize Our Lifestyle (COOL) program, a self-regulation theory-based mHealth program

What researchers measure

Primary outcomes

Cardiac disease knowledge
measured by the Leuven Knowledge Questionnaire for CHD
Time frame: 12 months

Secondary outcomes

Physical activity
measured by the International Physical Activity Questionnaire-Taiwan Show-Card Version
Time frame: 12 months

Study locations

1 site

National Yang-Ming University
Taipei, 11221, Taiwan

References and documents

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. PubMed 34151444 ↗
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. PubMed 33112424 ↗

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 11, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04264650
Lead sponsor: National Yang Ming Chiao Tung University
Responsible party: Chi-Wen Chen (Professor, National Yang Ming Chiao Tung University) — Principal investigator
First posted: Feb 11, 2020
Start date: Jun 1, 2016
Primary completion: Feb 28, 2018
Completion: Feb 28, 2018
Last update: Feb 11, 2020

Study contacts

Chi-Wen Chen, PhD

principal investigator · National Yang Ming Chiao Tung University

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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