Digital health program for children with congenital heart disease and their families

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to develop and evaluate a 12-week digital lifestyle intervention designed for children aged 8-13 with congenital heart disease and their guardians. Participants will use a Garmin Vivofit Jr. 2 wearable device to monitor their physical activity levels continuously. The intervention focuses on increasing moderate to vigorous physical activity, improving daily activity, enhancing quality of life, and boosting health literacy for both children and their parents. The study will assess the effectiveness of this digital approach in promoting healthier lifestyles among affected families.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Ages 8-14 years
* Presence of a congenital heart defect (must be moderate or complex according to ACC criteria)
* NYHA Class I or II
* Presence of written informed consent

Exclusion Criteria:

* Cognitive impairments that inhibit patients from understanding the tasks
* No sports clearance by paediatric cardiologists

Where it's running

• Department of Paediatric Cardiology and Congenital Heart Defects, German Heart Center of the State Bavaria (Munich), Technical University of Munich (TUM)
  München, Germany Recruiting

Study contacts

• Principal investigator: Jan Müller, Prof. Dr. — Technical University of Munich, Chair of preventive perdiatrics
• Study coordinator: Jan Müller, Prof. Dr.
• Email: j.mueller@tum.de
• Phone: ‭0176 21149304‬

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Evaluating heart and muscle function during exercise in children with heart disease

  This study is testing how well the hearts and muscles of kids with heart disease work during exercise to see if a special workout program can help them get stronger and healthier.

  Recruiting University of Alberta · Edmonton, Alberta · NCT06325280

• Home-based high intensity interval training for youth with congenital heart disease

  This study is testing if a home workout program using a special bike can help kids and teens with heart problems get stronger and feel better over eight weeks.

  Recruiting University of Alberta · Edmonton, Alberta · NCT04575883

• Nature-based program feasibility in preschools near public housing

  This feasibility study tests whether a nature-based program in preschools near public housing can be run smoothly and whether families will participate and benefit.

  Recruiting University Hospital Bispebjerg and Frederiksberg · Frederiksberg · NCT07780123

• Adapting and testing PEN-Plus in Zambian primary care

  Aiming to see if the PEN-Plus package can be adapted and used in two Zambian hospitals to better manage chronic diseases like heart disease, diabetes, hypertension, and sickle cell in primary care.

  Recruiting Centre for Infectious Disease Research in Zambia · Lusaka, Lusaka Province · NCT07753681

• Wireless NIRS Sensor Use in the NICU for Monitoring on Neonates

  A wireless NIRS sensor is tested on infants in the NICU to see how well it stays on and how it notes brain signals when used alongside standard wired sensors.

  Recruiting McGill University Health Centre/Research Institute of the McGill University Health Centre · Montreal, Quebec · NCT07732244

• Screening for lipid disorders in children and teens with chronic diseases to flag cardiovascular risk

  This study tests a blood test and a questionnaire to screen children and teens with chronic conditions for lipid metabolism disorders and familial hyperlipidemia.

  Recruiting Jena University Hospital · Jena · NCT07716488

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.