Abstract
Purpose: :
Barriers prevent dissemination of results of important clinical trials to communities. Many of these barriers also affect the conduct of translational research (recruitment and retention activities) designed to improve the dissemination of successful clinical trials. We report preliminary results of an NIH funded clinical trial designed to improve adherence to ADA guidelines for patients in medically underserved communities with diabetes. The intervention includes a retinal evaluation by telemedicine.
Methods: :
A total of 200 patients from two community health centers (FQHC's) will be randomized to a 12–month diabetes self–management intervention delivered by telemedicine or usual care. The intervention group is offered a retinal evaluation in the health center using a digital retinal camera with remote interpretation. Inclusion criteria obtained from the practice electronic system includes patients evaluated in the clinic within the past year, a diagnosis of diabetes, ≥35 years of age, a most recent A1C >7% and individuals whose health status allows safe participation in the study. A medical records review confirms a diabetes diagnosis. Information on demographics, medical history, and medications to further determine eligibility is obtained during a screening telephone call (TS). Those eligible are scheduled for two visits to the health center prior to randomization to obtain written informed consent, "run–in" activities, and baseline metabolic and anthropometric data.
Results: :
Recruitment of 58 participants for the first of two recruitment waves was recently completed. Of the 667 medical records reviewed in Wave 1, 49% were eligible. Of those eligible, TS was completed on 49%, of which 56% were scheduled for the enrollment visits. Approximately 91% of those completed the enrollment visits and were randomized (n=30, Intervention; n=28, Usual Care). Approximately 79% of those randomized were female, 64% were African American. At 6 months into the 12 month intervention, 50% (15/30) had retinal evaluations; 14 by telemedicine. Of the 14, 8 had no DR, 5 had NPDR 36% (5/14), and 1 was not graded. Those graded with moderate NPDR or worse, PDR, CSDME, or those with images ungradeable were referred.
Conclusions: :
Randomized clinical trials designed to evaluate dissemination methods may be successful in medically underserved communities with a committed community health center, versatile electronic systems, use of culturally appropriate materials and the application of novel technology such as telemedicine.
Keywords: diabetic retinopathy • diabetes • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials