The mission of a TrialNet Center is to engage subjects at risk for type 1 diabetes (T1D) in clinical trials to prevent or delay the onset of the disease. TrialNet's importance is emphasized by persistently high rates of nephropathy among people with T1D, despite declines in other microvascular complications and a recently reported increase in mortality among teens with T1D. With a population of 5.5 million, some 20,000 Atlantans have T1D. Thus, there is enormous opportunity to increase number of local TrialNet participants. This Center application proposes a 4-year plan to triple the current rate of TrialNet enrollment by the Emory University team and to improve the retention rate of autoantibody-positive subjects from 67 to 85 percent. These goals will be attained by expanding our recruiting outreach that has focused so far on the Emory pediatric diabetes clinic. We now propose to span all of Atlanta's pediatric endocrinology offices and selected, productive adult endocrinology practices. A history of collaboration among Atlanta's pediatric endocrinologists and the convergence of virtually all of the area's pediatric T1D patients on Children's Healthcare of Atlanta (CHOA) assure us access to virtually every family with an affected child. We further propose a series of office-based recruiting methods to introduce TrialNet to adult endocrinology offices in Atlanta. A greeter will make initial contact with patients visiting their endocrinologis for routine T1D care and facilitate methods to identify potentially interested relatives who will atten a screening event or enter TrialNet through a local laboratory. A custom mobile phone application will be designed to ease the patient's outreach to their family while keeping communications confidential. The greeter will rotate through the offices with a focus point being an off-hours screening event to be held at their physicians office in the coming month. These multi-media events will include educational exhibits/activities constructed by senior biomedical engineering students attending the Georgia Institute of Technology. The events and other TrialNet activities will be supported by a website hosted by Emory Pediatric Endocrinology and CHOA. Retention rates will be improved by implementing a motivational interviewing intervention. The intervention will be launched by completion of a 12-item questionnaire on Survey Monkey both before and after screening results are reported to subjects. It will determine each subject's motivation for participating in TrialNet and explore potential barriers to further activity should they turn out to be autoantibody-positive. After receiving a report of a positive autoantibody, a pediatric psychologist with expertise in motivational interviewing will us the survey information to guide an interview aimed at reducing barriers and encouraging retention in TrialNet. A TrialNet Center at Emory University will bring real growth to TrialNet without impinging on the activities of existing TrialNet Centers. It offers a highly trained staff, collaborations with innovative faculty and private practitioners, the ingenuity of bioengineers at Georgia Tech, and support from the many sites of the Atlanta Clinical and Translational Science Institute.

Public Health Relevance

Type 1 diabetes causes profound health complications and early death for as many as 3 million Americans. The TrialNet consortium aims to find treatments that prevent or delay the onset of type 1 diabetes. This proposal outlines methods for recruiting and retaining eligible participants in TrialNet throughout the Atlanta Metropolitan Service Area.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01DK106994-04
Application #
9478170
Study Section
Special Emphasis Panel (ZDK1)
Program Officer
Leschek, Ellen W
Project Start
2015-07-20
Project End
2019-04-30
Budget Start
2018-05-01
Budget End
2019-04-30
Support Year
4
Fiscal Year
2018
Total Cost
Indirect Cost
Name
Emory University
Department
Pediatrics
Type
Schools of Medicine
DUNS #
066469933
City
Atlanta
State
GA
Country
United States
Zip Code
30322
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