An interventional study of Heart2Heart in Congenital Heart Disease and Health Behavior, sponsored by Kristen Fox. Enrolling by invitation at 1 site in United States. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Kristen Fox · Not applicable, Interventional, and Prevention
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:
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:
991 studies on the registry are indexed under Heart Defects, Congenital; 251 are open to participants now.
This study's planned enrollment of 90 is above the median of 60 across 507 interventional studies indexed under Heart Defects, Congenital.
Browse Heart Defects, Congenital studies →Kristen Fox is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants in the control group will not receive access to Heart2Heart.
Participants in the intervention group will receive access to Heart2Heart.
Behavioral: Heart2Heart
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.
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).
Time frame: Feasibility will be evaluated throughout the recruitment, enrollment, and data collection process, lasting a period of three months.
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.
Time frame: Acceptability will be measured at the post-intervention survey, two weeks after participants are assigned to a study group.
Risk Behavior Diagnostics Scale for E-cigarettes (E-cigarette Efficacy)
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.
Time frame: Two weeks after participants are assigned to a study group
CATCH My Breath E-cigarette Attitude Survey (Perceived Positive Outcomes of E-cigarettes)
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).
Time frame: Two weeks after participants are assigned to a study group.
CATCH My Breath E-cigarette Knowledge Survey (E-cigarette Knowledge)
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.
Time frame: Two weeks after participants are assigned to a study group.
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Jul 2028, 23 months after the start.
Of 205 non-industry interventional studies with no phase under Heart Defects, Congenital, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 53. This study's planned 23 months is below that.
Counting every sponsor, half of 223 studies reached it within 34 months; a quarter within 17 and three quarters within 57.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Kristen Fox