Status:
COMPLETED
Self-Management in African Americans With Diabetes and Hypertension
Lead Sponsor:
Rush University Medical Center
Conditions:
Diabetes
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The primary aim of the study is to design a group-based, culturally appropriate self-management skills training intervention for disadvantaged African-Americans with both diabetes and hypertension and...
Eligibility Criteria
Inclusion
- Diagnosis of type 2 diabetes mellitus (HgA1c\>7%), requiring the patient to take at least one tablet per day or one insulin injection per day and a diagnosis of hypertension (130/80) requiring them to take at least one medication per day;
- Participants must identify themselves as African-American;
- Participant resides in or proximal to the North Lawndale neighborhood;
- Secure written permission from their physician to engage in moderate physical activity. This set of participants may be at high risk for cardiac disease and this exclusion avoids putting them at undue risk;
- BMI ≥ 25. Participant must be overweight because the main goal of our intervention is weight loss of 5% or more of initial body weight.
Exclusion
- Diet-controlled diabetes;
- Hypertension controlled with lifestyle modification only;
- Endstage renal disease, stroke with paresis, congestive heart failure (NYHA class 3 or 4), or other major endorgan complication of diabetes;
- Comorbid conditions limiting probable life span to \<4 years (e.g. cancer, AIDS) or indication of end-stage complications of diabetes (kidney dialysis, or transplant, blindness, or lower extremity amputation);
- Receiving treatment for a major psychiatric disorder (i.e. schizophrenia);
- Unable to give informed consent;
- Are under the age of 18-While type-2 diabetes and hypertension are increasing in those under the age of 18, adolescent medicine is a separate specialty area from adult medicine. Interventions should be targeted specifically toward this age group to take into consideration the specific emotional and psychological needs of adolescents;
- Alcoholism as measured by the CAGE.screener for alcohol abuse.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT01244152
Start Date
July 1 2008
End Date
July 1 2010
Last Update
November 19 2010
Active Locations (1)
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1
Rush University Medical Center
Chicago, Illinois, United States, 60612