NCT03231020 - 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)

Black AK, Sadanala UK, Mascio CE, Hornung CA, Keller BB
Challenges in implementing a pediatric cardiovascular home telehealth project. Telemed J E Health. 2014 Sep;20(9):858-67. doi: 10.1089/tmj.2013.0343. Epub 2014 Aug 1.
Rempel GR, Harrison MJ
Safeguarding precarious survival: parenting children who have life-threatening heart disease. Qual Health Res. 2007 Jul;17(6):824-37.
Shirali G, Erickson L, Apperson J, Goggin K, Williams D, Reid K, Bradley-Ewing A, Tucker D, Bingler M, Spertus J, Rabbitt L, Stroup R
Harnessing Teams and Technology to Improve Outcomes in Infants With Single Ventricle. Circ Cardiovasc Qual Outcomes. 2016 May;9(3):303-11. doi: 10.1161/CIRCOUTCOMES.115.002452. Epub 2016 May 10.
Yin RK
Enhancing the quality of case studies in health services research. Health Serv Res. 1999 Dec;34(5 Pt 2):1209-24. Review.

Parental Experience in the Single Ventricle Interstage Utilizing a mHealth Innovation: A Comparative Case Study

Clinical trial NCT03231020 - References