Breaking Down Barriers to Diabetes Self-Care

NCT ID: NCT00142922

Last Updated: 2010-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 222 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-10-31
• Study Completion Date: 2007-10-31

Brief 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.

Conditions

Type 1 Diabetes; Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

1

Attended Breaking Down Barriers program

Group Type: EXPERIMENTAL

Breaking Down Barriers

Intervention Type: BEHAVIORAL

completed

2

Attention control group

Group Type: ACTIVE_COMPARATOR

Breaking Down Barriers

Intervention Type: BEHAVIORAL

completed

3

Indivdual attention control group

Group Type: ACTIVE_COMPARATOR

Breaking Down Barriers

Intervention Type: BEHAVIORAL

completed

Interventions

Breaking Down Barriers

completed

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: lead

Principal Investigators

Katie Weinger, EdD

Role: PRINCIPAL_INVESTIGATOR

Joslin Diabetes Center/Harvard Medical School

Locations

Joslin Diabetes Center

Boston, Massachusetts, United States

Countries

United States

References

Weinger K, Beverly EA, Lee Y, Sitnokov L, Ganda OP, Caballero AE. The effect of a structured behavioral intervention on poorly controlled diabetes: a randomized controlled trial. Arch Intern Med. 2011 Dec 12;171(22):1990-9. doi: 10.1001/archinternmed.2011.502. Epub 2011 Oct 10.

Reference Type: DERIVED

PMID: 21986346 (View on PubMed)

Other Identifiers

DK 60115

Identifier Type: -

Identifier Source: secondary_id

CHS00-34

Identifier Type: -

Identifier Source: secondary_id

DK 60115 (completed)

Identifier Type: -

Identifier Source: org_study_id