NCT05709470 Mind the Heart - Mental Health in Children and Adolescents With Congenital Heart Defects
| NCT ID | NCT05709470 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rigshospitalet, Denmark |
| Condition | Heart Defects, Congenital |
| Study Type | OBSERVATIONAL |
| Enrollment | 4,800 participants |
| Start Date | 2023-03-17 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 4,800 participants in total. It began in 2023-03-17 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The aim of the Mind the Heart study is to document the feasibility of an online parent/child administered screening model for mental disorders (MDs) in Danish children and adolescents with congenital heart disease (CHD). As MDs in children and adolescents with chronic somatic health issues are frequently underdiagnosed and undertreated, we further aim to develop a website with evidence based information on mental health in children and adolescents with CHD in order to promote knowledge and awareness among families and health professionals across sectors.
Eligibility Criteria
Inclusion Criteria: * Born with a Congenital Heart Defect * Age 5-17y * (Living in Denmark) Exclusion Criteria: * Younger than 5years of age * Older than 17years of age * Lacking sufficient Danish language skills to answer the questionnaire
Contact & Investigator
Vibeke E Hjortdal, M.D, PhD, professor
STUDY DIRECTOR
University of Copenhagen
Frequently Asked Questions
Who can join the NCT05709470 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 17 Years, studying Heart Defects, Congenital. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05709470 currently recruiting?
Yes, NCT05709470 is actively recruiting participants. Contact the research team at sara.hirani.lau-jensen@regionh.dk for enrollment information.
Where is the NCT05709470 trial being conducted?
This trial is being conducted at Copenhagen, Denmark.
Who is sponsoring the NCT05709470 clinical trial?
NCT05709470 is sponsored by Rigshospitalet, Denmark. The principal investigator is Vibeke E Hjortdal, M.D, PhD, professor at University of Copenhagen. The trial plans to enroll 4,800 participants.