Breaking Down Barriers to Diabetes Self-Care
Breaking Down Barriers to Diabetes Self-Care
This study has been completed.
Sponsored by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00142922
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
MedlinePlus related topics: Diabetes Diabetes Type 1
U.S. FDA Resources
Study Type:Interventional
Study Design:Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:Breaking Down Barriers to Diabetes Self-Care
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
1: Experimental
Attended Breaking Down Barriers program Behavioral: Breaking Down Barriers
completed
2: Active Comparator
Attention control group Behavioral: Breaking Down Barriers
completed
3: Active Comparator
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
Study ID Numbers:DK 60115, DK 60115, CHS00-34
First Received:August 31, 2005
Last Updated:December 7, 2007
ClinicalTrials.gov Identifier:NCT00142922 [history]
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
Study placed in the following topic categories:
Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Additional relevant MeSH terms:
Immune System Diseases
Votes:26
Comments: 0