Patient response to a clinical study for diabetes education interventions: demographic differences between patients who enrolled and those not interested in participating [abstract] Abstract uri icon
  • Background and Aims: The Journey for Control of Diabetes: the IDEA Study, a randomized clinical study, is evaluating the effectiveness of an interactive, group-based learning experience using Conversation Maps. Patients with uncontrolled diabetes were sent letters describing the study and subsequently contacted to assess eligibility and interest. Recruitment, estimated to take 5 months, was extended to 11 months due to difficulties in obtaining a committed group of eligible participants. Because of these recruitment difficulties, we examined differences between the enrolled subgroup and those who indicated they were not interested in participation in an attempt to identify patient characteristics of those who enrolled. Methods: Of the 4197 patients sent recruitment letters, 286 enrolled, 1345 were not interested in participating, and the remaining 2567 were unable to participate for a variety of reasons. Demographic variables of interest were gender, age, ethnicity and A1C level. We used a software tool, GUESS, which utilizes surname to determine ethnicity. A logistic regression model predicting enrollment was fit to the data using a binary logit link. Results: The model had a strong predictive accuracy with a likelihood ratio test resulting in p<.0001. To further dissect the significance of the variables, individual maximum ratio tests were performed. Age was a very significant predictive variable (p<.0001) with older subjects less likely to enroll. Gender was not significant (p=.14). The subjects' A1C prior to recruitment was also significant (p<.0001) with the highest enrollment in the groups close to goal (A1C < 7.5) and those with very high A1C's (A1C > 9.0). Finally, ethnicity was significant (p=.0005) with white non-Hispanics more likely to enroll than Hispanics. Conclusions: Several demographic variables were used to assess their impact on a person's desire to participate in the IDEA Study. Of those who met the eligibility criteria, enrolled people were younger, fewer were Hispanic, and more had A1C's either almost at goal or extremely out of control. A better understanding of which potential participants may be more willing to enroll in a study could provide insight into more effective recruitment.

  • publication date
  • 2010
  • published in
  • Demography
  • Diabetes
  • Health Education
  • Randomized Controlled Trials
  • Recruitment
  • Additional Document Info
  • 8
  • issue
  • 3-4