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OpenTrials
Completed

NCT Number: NCT07063654

Mobile Health Program for Teens With Congenital Heart Disease

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.

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Key information

Conditions

Congenital Heart Disease in Adolescence Behavior Health Behavior

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of structural congenital heart disease
  • 12-18 years of age at time of study enrollment

Exclusion criteria

  • Cognitive impairments limiting the ability to complete surveys or interviews
  • Not proficient in the English language
  • Leaving the United States during the study period
  • Does not have access to a device that can connect to the internet

Treatment and study plan

Heart2Heart

Behavioral

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.

Primary outcomes

  1. Satisfaction with mHealth Program

    Time frame: Two weeks after receiving access to the mobile health 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").

  2. Usability of mHealth Program

    Time frame: Two weeks after receiving access to the mobile health 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").

Sponsors and collaborators

Lead sponsor

Kristen Fox

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • Ohio State University

Registry information

Official study title

Creating a Mobile Health Program for Teens With Congenital Heart Disease

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 14, 2025
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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