Status:
COMPLETED
Enhancing Adherence in Type 2 Diabetes: The ENHANCE Study
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
National Institute of Nursing Research (NINR)
Conditions:
Diabetes Mellitus, Type 2
Diabetic Nephropathy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This randomized study will test a behavioral intervention, based on social cognitive theory (SCT), to improve regimen adherence in three different groups of people with type 2 diabetes; (1) those with...
Detailed Description
This randomized study, the ENHANCE Study (Enhancing Adherence to Diabetes Self-Management) will test a behavioral intervention, based on social cognitive theory (SCT), to improve regimen adherence in ...
Eligibility Criteria
Inclusion
- Study subjects will include those with: type 2 diabetes mellitus defined according to the 1997 ADA criteria and age of 18 years or greater. We will sample from three different patient populations: (1) 96 individuals who have HbA1c \< 8%, and no evidence of chronic renal insufficiency (a serum creatinine \<1.3mg/dl for women and \<1.5mg/dl for men). (2) 96 individuals with HbA1c \> 8%, and no evidence of chronic renal insufficiency, and (3) 96 individuals with evidence of chronic renal insufficiency (a serum creatinine \>1.3mg/dl for women and \>1.5mg/dl for men, but who have not yet progressed to dialysis), regardless of HbA1c level.
- \-
Exclusion
- Exclusion criteria were selected to enhance safety and ability to complete the study protocol. They include: (1) history of hypoglycemic coma/seizure within the last 12 months, (2) hypoglycemia requiring 3rd party assistance within the last 3 months, (3) history consistent with type 1 diabetes, (4) unwillingness to do capillary blood testing using the FreeStyle monitor, (5) unwillingness or inability to participate in scheduled group classes or individual counseling sessions, (7) subjects currently on renal dialysis, (8) any factors likely to preclude adherence to the study protocol including dementia, alcohol or substance abuse, plan to move within the next 8 months, lack of support from the subject's primary health care provider (i.e. PCP is aware of significant risks such as extreme variation in blood glucoses and/or comorbidities that would make participation in the study unsafe), failure to obtain informed consent from the participant, current participation in another clinical trial, and (9) subjects who are not available by telephone during the hours of 8am to 6pm.
- \-
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
288 Patients enrolled
Trial Details
Trial ID
NCT00222846
Start Date
May 1 2004
End Date
December 1 2009
Last Update
May 17 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, United States, 15213