Breaking Down Barriers to Diabetes Self-Care

Study Overview
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Brief Summary
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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.

Official Title
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Breaking Down Barriers to Diabetes Self-Care

Conditions
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Type 1 Diabetes, Type 2 Diabetes

Intervention / Treatment
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* Behavioral: Breaking Down Barriers


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For Patients With Type 1 Diabetes Aged 18-65 Presence of type 1 diabetes mellitus. 2-25 year duration. For Patients With Type 2 Diabetes Aged 25-65 years presence of type 2 diabetes mellitus. 2 years since initial diagnosis. Exclusion Criteria: Renal disease, microalbumin >300 ug/mg) Severe peripheral diabetic neuropathy and/or severe peripheral vascular disease Symptomatic severe autonomic neuropathy who may be at risk when increasing activity levels. Women who are currently pregnant proliferative diabetic retinopathy based on dilated eye examination within one year of study entry. Patients whose eye disease is successfully treated will be included. HbA1c levels less than 7.0% (normal range 4.0 - 6.0%). HbA1c levels greater than 14.0% patients who underwent intensive insulin treatment within one year a history of severe, unstable myocardial infarction, congestive heart failure or other severe cardiac disease, severe hypertension (systolic more than 160 mmHg or diastolic 90 mmHg) who may be at risk when mildly increasing physical activity a DSMIV diagnosis of eating disorders including anorexia nervosa, bulimia, and severe weight-related insulin omission. Patients with recent diagnosis (past 6 months) of bipolar disorder, schizophrenia, mental retardation, organic mental disorder, and alcohol or drug abuse Patients whose diabetes diagnosed cannot be clearly classified as type 1 or type 2.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Attended Breaking Down Barriers program | Behavioral: Breaking Down Barriers<br>* completed<br>|
| Active Comparator: 2<br>Attention control group | Behavioral: Breaking Down Barriers<br>* completed<br>|
| Active Comparator: 3<br>Indivdual attention control group | Behavioral: Breaking Down Barriers<br>* completed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-Care Behaviors |  |  | 
| Glycemic control (HbA1c) |  |  | 
| fitness |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  |  | 
| Diabetes Related emaitonal distress |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adherence, self-care, Behavioral intervention, Diabetes