Creating a Mobile Health Program for Teens With Congenital Heart Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Percent of participants with favorable satisfaction and usability ratings (Acceptability)
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 12 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Treatment-as-Usual
Participants in the control group will not receive access to Heart2Heart.
Heart2Heart
Participants in the intervention group will receive access to Heart2Heart.
Intervention: Heart2Heart (Behavioral)
Outcomes
Primary Outcomes
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.
Percent of participants completing trial activities (Feasibility)
Time Frame: Feasibility will be evaluated throughout the recruitment, enrollment, and data collection process, lasting a period of three months.
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).
Secondary Outcomes
No secondary outcomes reported
Investigators
Kristen Fox
Principal Investigator
Nationwide Children's Hospital