Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07764510

Heart2Heart for Teens With CHD

The goal of this clinical trial is to learn if teens living with congenital heart disease like and will use Heart2Heart and if it affects how they think and feel about e-cigarettes. Heart2Heart is a website that provides health information for teens with congenital heart disease. The main questions this trial aims to answer are:

* Will teens enroll in the trial and complete the trial activities? * Do teens use and like Heart2Heart? * Does using Heart2Heart affect how teens think and feel about e-cigarettes?

Researchers will compare the Heart2Heart group to a group that does not use Heart2Heart to see if it affects teens' thoughts and feelings about e-cigarettes.

Participants will:

* Complete online surveys * If assigned, explore the Heart2Heart website * If invited, share their opinions about Heart2Heart in an online discussion

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Congenital Heart Disease Behavior Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Health Behavior Heart Defects, Congenital Heart Diseases

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 12-18 years of age
  • diagnosis of structural congenital heart disease
  • if under 18, has a parent or legal guardian proficient in English or Spanish

Exclusion criteria

  • teen not proficient in English
  • teen has cognitive impairments that interfere with completion of the study activities
  • teen was a participant in one of the Heart2Heart development studies
  • teen does not have access to a device that can connect to the internet
  • teen is leaving the United States during their study period

Treatment and study plan

Heart2Heart

Behavioral

Heart2Heart is a website 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. Percent of participants completing trial activities (Feasibility)

    Time frame: Feasibility will be evaluated throughout the recruitment, enrollment, and data collection process.

    The following aspects of feasibility will be evaluated: recruitment rate (number enrolled/number invited), retention rate (number completing trial activities/number randomized to a group), and assessment completion rate (percent of participants completing the trial surveys).

  2. Percent of participants with favorable satisfaction and usability ratings (Acceptability)

    Time frame: Acceptability will be measured at the post-intervention survey, two weeks after participants are assigned to a study group.

    To evaluate acceptability, the percentage of teens with favorable (the highest two ratings on the scale) usability and satisfaction ratings will be calculated.

Other outcomes

  1. Risk Behavior Diagnostics Scale for E-cigarettes (E-cigarette Efficacy)

    Time frame: Two weeks after participants are assigned to a study group

    Six statements assessing self-efficacy (e.g., "I am confident I can avoid using vaping devices") and response efficacy (e.g., "The health effects of using vaping devices are serious"). Items are rated on a 1 (Strongly Disagree) to 5 (Strongly Agree) scale.

  2. CATCH My Breath E-cigarette Attitude Survey (Perceived Positive Outcomes of E-cigarettes)

    Time frame: Two weeks after participants are assigned to a study group.

    Four items measuring perceived positive outcomes of vaping (e.g., "Using e-cigarettes would help me to deal with problems or stress") rated on a 4-point scale ranging from 0 (strongly disagree) to 3 (strongly agree).

  3. CATCH My Breath E-cigarette Knowledge Survey (E-cigarette Knowledge)

    Time frame: Two weeks after participants are assigned to a study group.

    Six questions or statements related to knowledge and beliefs of e-cigarettes (e.g., "E-cigarette vapor contains mostly water"). Respondents select "yes," "no," or "I don't know", or select the correct response from a list of choices.

Study contacts

Contact information is provided by the study sponsor or research team.

Kristen Fox, PhD

CONTACT

[email protected]

614-355-3692

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
2026
Primary completion
2028
Study completion
2028
First posted
Aug 14, 2026
Registry last updated
Aug 14, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.