Mobile Health Program for Teens With Congenital Heart Disease
Creating a Mobile Health Program for Teens With Congenital Heart Disease
2 other identifiers
interventional
17
1 country
1
Brief Summary
The goal of this clinical trial is to understand what teens with congenital heart disease like and want in a mobile health program that helps them learn about their health and make healthy choices. The main questions it aims to answer are: Are participants satisfied with the program? Is the program easy to use? Participants will: 1) complete two online surveys, 2) interact with the mobile health program, and 3) participate in an interview.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 3, 2025
CompletedFirst Posted
Study publicly available on registry
July 14, 2025
CompletedStudy Start
First participant enrolled
July 17, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 2, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 2, 2025
CompletedNovember 12, 2025
November 1, 2025
4 months
July 3, 2025
November 7, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Satisfaction with mHealth Program
Participants' satisfaction with the mobile health program, for example, how much it increased their knowledge and how enjoyable it was. Participants respond to questions on a 4-point scale ("Strongly Disagree to Strongly Agree").
Two weeks after receiving access to the mobile health program
Usability of mHealth Program
How easy and enjoyable participants think the program is to use, for example, how easy it was to find information or how much they liked the images. Participants respond to questions on a 7-point scale (1="Very Unsatisfied", 7="Very Satisfied").
Two weeks after receiving access to the mobile health program
Study Arms (1)
Mobile Health Program
EXPERIMENTALParticipants in this arm will receive access to Heart2Heart. Heart2Heart is a mobile health program for teens with congenital heart disease. It includes information and interactive features to help teens learn about staying healthy with congenital heart disease.
Interventions
Heart2Heart is a mobile health program for teens with congenital heart disease. It includes information and interactive features to help teens learn about staying healthy with congenital heart disease.
Eligibility Criteria
You may qualify if:
- Diagnosis of structural congenital heart disease
- years of age at time of study enrollment
You may not qualify if:
- Cognitive impairments limiting the ability to complete surveys or interviews
- Not proficient in the English language
- Leaving the United States during the study period
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kristen Foxlead
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
- Ohio State Universitycollaborator
Study Sites (1)
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 3, 2025
First Posted
July 14, 2025
Study Start
July 17, 2025
Primary Completion
November 2, 2025
Study Completion
November 2, 2025
Last Updated
November 12, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share