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Sponsored by: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
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Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
ClinicalTrials.gov Identifier: | NCT00142922 |
Performance of self-care recommendations is key to the successful treatment of diabetes. However, many patients have difficulty adhering to diabetes self-care recommendations. Recent results from our own studies and others have identified specific barriers to diabetes self-care. To evaluate the efficacy of a diabetes educator-led group intervention, the Breaking Down Barriers Program, that addresses barriers and therefore leads to improved adherence to diabetes self-care recommendations, we will randomize 222 (111 type 1 and 111 type 2) diabetes patients to one of three conditions: 1) the Breaking Down Barriers Program, 2) a cholesterol attention control condition, or 3) a 'usual care' control condition. We hypothesize that those assigned to the Breaking Down Barriers group will improve self-care behaviors and glycemic control more than those in the two control groups. We will follow study subjects for one year to determine whether their self-care behaviors and glycemic control improved and if the improvement was maintained over time.
Condition | Intervention |
---|---|
Type 1 Diabetes Type 2 Diabetes |
Behavioral: Breaking Down Barriers |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Breaking Down Barriers to Diabetes Self-Care |
Estimated Enrollment: | 222 |
Study Start Date: | October 2002 |
Estimated Study Completion Date: | October 2007 |
Arms | Assigned Interventions |
---|---|
1: Experimental
Attended Breaking Down Barriers program
|
Behavioral: Breaking Down Barriers
completed
|
2: Active Comparator
Attention control group
|
Behavioral: Breaking Down Barriers
completed
|
3: Active Comparator
Indivdual attention control group
|
Behavioral: Breaking Down Barriers
completed
|
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
For Patients With Type 1 Diabetes
For Patients With Type 2 Diabetes
Exclusion Criteria:
United States, Massachusetts | |
Joslin Diabetes Center | |
Boston, Massachusetts, United States, 02215 |
Principal Investigator: | Katie Weinger, EdD | Joslin Diabetes Center/Harvard Medical School |
Study ID Numbers: | DK 60115, DK 60115, CHS00-34 |
Study First Received: | August 31, 2005 |
Last Updated: | December 7, 2007 |
ClinicalTrials.gov Identifier: | NCT00142922 |
Health Authority: | United States: Federal Government |
Adherence self-care Behavioral intervention Diabetes |
Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |
Immune System Diseases |