Clinical trial NCT00142922: Breaking Down Barriers to Diabetes Self-Care
Official title: Breaking Down Barriers to Diabetes Self-Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Type 2 Diabetes
Keywords: Adherence
self-care
Behavioral intervention
Diabetes
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2005-09-02
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


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.

Primary outcomes:
measure: Self-Care Behaviors
measure: Glycemic control (HbA1c)
measure: fitness
Secondary outcomes:
measure: Quality of life
measure: Diabetes Related emaitonal distress
Other outcomes:
Locations:
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
Study officials:
affiliation: Joslin Diabetes Center/Harvard Medical School
name: Katie Weinger, EdD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.