Effectiveness of an mHealth Intervention for Youth With Congenital Heart Disease
Primary Purpose
Congenital Heart Disease, Adolescent Behavior
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
an mHealth intervention
Sponsored by
About this trial
This is an interventional health services research trial for Congenital Heart Disease
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
Sites / Locations
- National Yang-Ming University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Control group
One active intervention group
The other active intervention group
Arm Description
Standard care
provided with COOL Passport, a mobile healthcare application
provided with access to the Health Promotion Cloud system and use of game-based interactive platforms along with COOL Passport
Outcomes
Primary Outcome Measures
Cardiac disease knowledge
measured by the Leuven Knowledge Questionnaire for CHD
Secondary Outcome Measures
Physical activity
measured by the International Physical Activity Questionnaire-Taiwan Show-Card Version
Full Information
NCT ID
NCT04264650
First Posted
February 9, 2020
Last Updated
February 9, 2020
Sponsor
National Yang Ming University
1. Study Identification
Unique Protocol Identification Number
NCT04264650
Brief Title
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
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2016 (Actual)
Primary Completion Date
February 28, 2018 (Actual)
Study Completion Date
February 28, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Yang Ming University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease, Adolescent Behavior
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
143 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Standard care
Arm Title
One active intervention group
Arm Type
Experimental
Arm Description
provided with COOL Passport, a mobile healthcare application
Arm Title
The other active intervention group
Arm Type
Experimental
Arm Description
provided with access to the Health Promotion Cloud system and use of game-based interactive platforms along with COOL Passport
Intervention Type
Behavioral
Intervention Name(s)
an mHealth intervention
Intervention Description
The Care & Organize Our Lifestyle (COOL) program, a self-regulation theory-based mHealth program
Primary Outcome Measure Information:
Title
Cardiac disease knowledge
Description
measured by the Leuven Knowledge Questionnaire for CHD
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Physical activity
Description
measured by the International Physical Activity Questionnaire-Taiwan Show-Card Version
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chi-Wen Chen, PhD
Organizational Affiliation
National Yang Ming University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Yang-Ming University
City
Taipei
ZIP/Postal Code
11221
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34151444
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.
Results Reference
derived
PubMed Identifier
33112424
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.
Results Reference
derived
Learn more about this trial
Effectiveness of an mHealth Intervention for Youth With Congenital Heart Disease
We'll reach out to this number within 24 hrs