Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Breaking Down Barriers to Diabetes Self-Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00142922
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : March 2, 2010
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Type 2 Diabetes Behavioral: Breaking Down Barriers Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 222 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Breaking Down Barriers to Diabetes Self-Care
Study Start Date : October 2002
Study Completion Date : October 2007

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Self-Care Behaviors
  2. Glycemic control (HbA1c)
  3. fitness

Secondary Outcome Measures :
  1. Quality of life
  2. Diabetes Related emaitonal distress

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00142922


Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Katie Weinger, EdD Joslin Diabetes Center/Harvard Medical School
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00142922    
Other Study ID Numbers: DK 60115 (completed)
DK 60115
CHS00-34
First Posted: September 2, 2005    Key Record Dates
Last Update Posted: March 2, 2010
Last Verified: March 2010
Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Adherence
self-care
Behavioral intervention
Diabetes
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases