NCT04264650

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
143

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2018

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

February 9, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 11, 2020

Completed
Last Updated

February 11, 2020

Status Verified

February 1, 2020

Enrollment Period

1.7 years

First QC Date

February 9, 2020

Last Update Submit

February 9, 2020

Conditions

Congenital Heart DiseaseAdolescent Behavior

Outcome Measures

Primary Outcomes (1)

  • Cardiac disease knowledge

    measured by the Leuven Knowledge Questionnaire for CHD

    12 months

Secondary Outcomes (1)

  • Physical activity

    12 months

Study Arms (3)

Control group

NO INTERVENTION

Standard care

One active intervention group

EXPERIMENTAL

provided with COOL Passport, a mobile healthcare application

Behavioral: an mHealth intervention

The other active intervention group

EXPERIMENTAL

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

an mHealth interventionBEHAVIORAL

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

One active intervention groupThe other active intervention group

Eligibility Criteria

Age15 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Yang-Ming University

Taipei, 11221, Taiwan

Location

Related Publications (2)

  • 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.

    PMID: 34151444DERIVED

  • 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.

    PMID: 33112424DERIVED

MeSH Terms

Conditions

Heart Defects, CongenitalAdolescent Behavior

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesBehavior

Study Officials

  • Chi-Wen Chen, PhD

    National Yang Ming Chiao Tung University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 9, 2020

First Posted

February 11, 2020

Study Start

June 1, 2016

Primary Completion

February 28, 2018

Study Completion

February 28, 2018

Last Updated

February 11, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)