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Breaking Down Barriers to Diabetes Self-Care

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00142922
First received: August 31, 2005
Last updated: March 1, 2010
Last verified: March 2010
History of Changes
  Purpose

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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Breaking Down Barriers to Diabetes Self-Care

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • Self-Care Behaviors
  • Glycemic control (HbA1c)
  • fitness

Secondary Outcome Measures:
  • Quality of life
  • Diabetes Related emaitonal distress

Estimated Enrollment: 222
Study Start Date: October 2002
Estimated Study Completion Date: October 2007
Arms Assigned Interventions
Experimental: 1
Attended Breaking Down Barriers program
 Behavioral: Breaking Down Barriers
completed
Active Comparator: 2
Attention control group
 Behavioral: Breaking Down Barriers
completed
Active Comparator: 3
Indivdual attention control group
 Behavioral: Breaking Down Barriers
completed

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00142922

Locations
United States, Massachusetts
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Katie Weinger, EdD Joslin Diabetes Center/Harvard Medical School
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00142922     History of Changes
Other Study ID Numbers: DK 60115 (completed), DK 60115, CHS00-34
Study First Received: August 31, 2005
Last Updated: March 1, 2010
Health Authority: United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Adherence
self-care
Behavioral intervention
Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013