Congenital Heart Disease in AdolescenceNCT07063654
Mobile Health Program for Teens With Congenital Heart Disease
A study testing Heart2Heart in people with Congenital Heart Disease in Adolescence and Health Behavior, run by Kristen Fox at 1 site in United States.
Trial summary
The goal of this clinical trial is to understand what teens with congenital heart disease like and want in a mobile health program that helps them learn about their health and make healthy choices. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Congenital Heart Disease in Adolescence, 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
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2025to 2 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Diagnosis of structural congenital heart disease
- 12-18 years of age at time of study enrollment
Who cannot join
- Cognitive impairments limiting the ability to complete surveys or interviews
- Not proficient in the English language
- Leaving the United States during the study period
- Does not have access to a device that can connect to the internet
Trial locations and contacts
1 site in 1 country.
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 understand what teens with congenital heart disease like and want in a mobile health program that helps them learn about their health and make healthy choices. The main questions it aims to answer are:
Are participants satisfied with the program? Is the program easy to use?
Participants will: 1) complete two online surveys, 2) interact with the mobile health program, and 3) participate in an interview.
- Being tested
- Heart2Heart
- Medical subject headings
- 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 mobile health program 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 |
|---|---|---|
| Mobile Health Program | Experimental | Participants in this arm will receive access to Heart2Heart. Heart2Heart is a mobile health program for teens with congenital heart disease. It includes information and interactive features to help teens learn about staying healthy with congenital heart disease. Receives: Behavioral: Heart2Heart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction with mHealth Program
Participants' satisfaction with the mobile health program, for example, how much it increased their knowledge and how enjoyable it was. Participants respond to questions on a 4-point scale ("Strongly Disagree to Strongly Agree").
Measured: Two weeks after receiving access to the mobile health program
Usability of mHealth Program
How easy and enjoyable participants think the program is to use, for example, how easy it was to find information or how much they liked the images. Participants respond to questions on a 7-point scale (1="Very Unsatisfied", 7="Very Satisfied").
Measured: Two weeks after receiving access to the mobile health program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start17 Jul 2025
- Primary completion2 Nov 2025
- Study completion2 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart Disease in AdolescenceStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
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
- NCT07063654
- Sponsor's protocol ID
- STUDY00003377
- Other IDs
- K23HL166771
- Status last verified
- Nov 2025
- First submitted
- 3 Jul 2025
- Last updated
- 17 Jun 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 17 Jun 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
- NCT07063654
- Acronym / sponsor ID
- STUDY00003377
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Kristen FoxUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Ohio State University
- Study start
- 17 Jul 2025 (actual)
- Primary completion
- 2 Nov 2025 (actual)
- Study completion
- 2 Nov 2025 (actual)
- First posted
- 14 Jul 2025 (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 understand what teens with congenital heart disease like and want in a mobile health program that helps them learn about their health and make healthy choices. The main questions it aims to answer are:
Are participants satisfied with the program? Is the program easy to use?
Participants will: 1) complete two online surveys, 2) interact with the mobile health program, and 3) participate in an interview.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mobile Health Program | Experimental | Behavioral: Heart2HeartParticipants in this arm will receive access to Heart2Heart. Heart2Heart is a mobile health program for teens with congenital heart disease. It includes information and interactive features to help teens learn about staying healthy with congenital heart disease. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Diagnosis of structural congenital heart disease
- 12-18 years of age at time of study enrollment
Key exclusion criteria (4 listed)
- Cognitive impairments limiting the ability to complete surveys or interviews
- Not proficient in the English language
- Leaving the United States during the study period
- Does not have access to a device that can connect to the internet
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 mobile health program for teens with congenital heart disease. It includes information and interactive features to help teens learn about staying healthy with congenital heart disease. | Behavioural | Mobile Health Program |
Primary outcome
Satisfaction with mHealth Program
Time frame: Two weeks after receiving access to the mobile health program
Participants' satisfaction with the mobile health program, for example, how much it increased their knowledge and how enjoyable it was. Participants respond to questions on a 4-point scale ("Strongly Disagree to Strongly Agree").
Usability of mHealth Program
Time frame: Two weeks after receiving access to the mobile health program
How easy and enjoyable participants think the program is to use, for example, how easy it was to find information or how much they liked the images. Participants respond to questions on a 7-point scale (1="Very Unsatisfied", 7="Very Satisfied").
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 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. This study is not recruiting at the moment.
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 in Adolescence 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 17 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Satisfaction with mHealth Program (time frame: Two weeks after receiving access to the mobile health program). 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 17 Jun 2026.