NCT05479630 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

de Hosson M, De Backer J, De Wolf D, De Groote K, Demulier L, Mels S, Vandekerckhove K, Goossens E
Development of a transition program for adolescents with congenital heart disease. Eur J Pediatr. 2020 Feb;179(2):339-348. doi: 10.1007/s00431-019-03515-4. Epub 2019 Nov 22.
Moons P, De Volder E, Budts W, De Geest S, Elen J, Waeytens K, Gewillig M
What do adult patients with congenital heart disease know about their disease, treatment, and prevention of complications? A call for structured patient education. Heart. 2001 Jul;86(1):74-80. doi: 10.1136/heart.86.1.74.
van Staa A, Sattoe JN
Young adults' experiences and satisfaction with the transfer of care. J Adolesc Health. 2014 Dec;55(6):796-803. doi: 10.1016/j.jadohealth.2014.06.008. Epub 2014 Aug 19.
Warnes CA, Liberthson R, Danielson GK, Dore A, Harris L, Hoffman JI, Somerville J, Williams RG, Webb GD
Task force 1: the changing profile of congenital heart disease in adult life. J Am Coll Cardiol. 2001 Apr;37(5):1170-5. doi: 10.1016/s0735-1097(01)01272-4. No abstract available.

A Prospective Quasi-Experimental Study to Evaluate Transition With a Heart, a Transition Project for Adolescents With Congenital Heart Disease and Their Parents With Focus on Disease Knowledge and Transitional Skills

Details for clinical trial NCT05479630

Clinical trial NCT05479630 - References