Breaking Down Barriers to Diabetes Self-Care

Type 2 Diabetes Clinical Trial

Official title:

Breaking Down Barriers to Diabetes Self-Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00142922
• Other study ID #: DK 60115 (completed)
• Secondary ID: DK 60115CHS00-34
• Status: Completed
• Phase: N/A
• First received: August 31, 2005
• Last updated: March 1, 2010
• Start date: October 2002
• Est. completion date: October 2007

Study information

• Verified date: March 2010
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus
• Type 1 Diabetes
• Type 2 Diabetes

Intervention

Behavioral:
• Breaking Down Barriers
completed

Locations

Country	Name	City	State
United States	Joslin Diabetes Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-Care Behaviors
Primary	Glycemic control (HbA1c)
Primary	fitness
Secondary	Quality of life
Secondary	Diabetes Related emaitonal distress