NCT01152957 - 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)

Carrasquillo O, Lebron C, Alonzo Y, Li H, Chang A, Kenya S
Effect of a Community Health Worker Intervention Among Latinos With Poorly Controlled Type 2 Diabetes: The Miami Healthy Heart Initiative Randomized Clinical Trial. JAMA Intern Med. 2017 Jul 1;17
Carrasquillo O, Patberg E, Alonzo Y, Li H, Kenya S
Rationale and design of the Miami Healthy Heart Initiative: a randomized controlled study of a community health worker intervention among Latino patients with poorly controlled diabetes. Int J Gen Med. 2014 Feb 27;7:115-26. doi: 10.2147/IJGM.S56250. eCollection 2014.
Chang A, Kenya S, Ilangovan K, Li H, Koru-Sengul T, Alonzo Y, Carrasquillo O
Is greater acculturation associated with an increased prevalence of cardiovascular risk factors among Latinos in South Florida? Med Care. 2015 May;53(5):417-22. doi: 10.1097/MLR.0000000000000337.
Chang A, Patberg E, Cueto V, Li H, Singh B, Kenya S, Alonzo Y, Carrasquillo O
Community Health Workers, Access to Care, and Service Utilization Among Florida Latinos: A Randomized Controlled Trial. Am J Public Health. 2018 Sep;108(9):1249-1251. doi: 10.2
Kenya S, Lebron CN, Chang AY, Li H, Alonzo YA, Carrasquillo O
A profile of Latinos with poorly controlled diabetes in South Florida. J Community Hosp Intern Med Perspect. 2015 Apr 1;5(2):26586. doi: 10.3402/jchimp.v5.26586. eCollection 2015.
Lebron CN, Reyes-Arrechea E, Castillo A, Carrasquillo O, Kenya S
Tales from the Miami Healthy Heart Initiative: the experiences of two community health workers. J Health Care Poor Underserved. 2015 May;26(2):453-62. doi: 10.1353/hpu.2015.0033.

Miami Healthy Heart Initiative (MHHI) a Randomized Study of Behavioral Risk Factors for Cardiovascular Disease in Latino and Hispanic Patients With Poorly Controlled Diabetes

Details for clinical trial NCT01152957

Clinical trial NCT01152957 - References