Heart2Heart for Teens With CHD

NCT07764510 | Not Yet Recruiting

• 2 other identifiers: STUDY#00003377K23HL166771
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Congenital Heart Disease; Health Behavior

Outcome Measures

Primary Outcomes (2)

• Percent of participants completing trial activities (Feasibility)

  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).

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

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

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

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

Other Outcomes (3)

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

  Two weeks after participants are assigned to a study group

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

  Two weeks after participants are assigned to a study group.

• CATCH My Breath E-cigarette Knowledge Survey (E-cigarette Knowledge)

  Two weeks after participants are assigned to a study group.

Study Arms (2)

Treatment-as-Usual

NO INTERVENTION

Participants in the control group will not receive access to Heart2Heart.

Heart2Heart

EXPERIMENTAL

Participants in the intervention group will receive access to Heart2Heart.

Behavioral: Heart2Heart

Interventions

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.

Heart2Heart

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kristen Fox: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Ohio State University: collaborator

MeSH Terms

Conditions

Heart Defects, Congenital; Health Behavior

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Behavior

Central Study Contacts

Kristen Fox, PhD

CONTACT

614-355-3692; kristen.fox@nationwidechildrens.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 14, 2026
• Study Start (Estimated): August 17, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: August 14, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share