Congenital Heart DiseaseNCT07764510
Heart2Heart for Teens With CHD
A study testing Heart2Heart in people with Congenital Heart Disease and Health Behavior, run by Kristen Fox at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Congenital Heart Disease, Health Behavior
- What is being tested?
- Heart2Heart
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2026to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: Creating a Mobile Health Program for Teens With Congenital Heart Disease
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?
Read more
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
- Being tested
- Heart2Heart
- Medical subject headings
- Heart Defects, Congenital, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart2HeartBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Heart2Heart |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Acceptability will be measured at the post-intervention survey, two weeks after participants are assigned to a study group.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start18 Aug 2026
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kristen Fox
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kristen Fox, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07764510
- Sponsor's protocol ID
- STUDY#00003377
- Other IDs
- K23HL166771
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creating a Mobile Health Program for Teens With Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT07764510
- Acronym / sponsor ID
- STUDY#00003377
- Conditions
- Congenital Heart Disease, Health Behavior
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Kristen FoxUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Ohio State University
- Study start
- 18 Aug 2026 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 14 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment-as-Usual | No intervention | –Participants in the control group will not receive access to Heart2Heart. |
| Heart2Heart | Experimental | Behavioral: Heart2HeartParticipants in the intervention group will receive access to Heart2Heart. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heart2HeartHeart2Heart 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. | Behavioural | Heart2Heart |
Primary outcome
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).
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heart2Heart in people with Congenital Heart Disease and Health Behavior, run by Kristen Fox at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.