Clinical trial NCT00645528: Do Group Insulin Education Visits Reduce Barriers to Insulin Initiation?
Official title: Do Group Insulin Education Visits Reduce Barriers to Insulin Initiation?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: insulin
teaching
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2008-03-27
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this research is to determine if meeting in a group with other subjects with diabetes can reduce barriers to starting insulin.

Detailed description: Diabetes is a common, morbid and expensive disease among veterans. Achieving and maintaining adequate glycemic control can reduce the devastating complications of diabetes. Unfortunately a large percentage of veterans with type 2 diabetes continue to have poorly controlled blood sugars. Insulin is the most potent medication for reducing glycemia, but is not used often enough due to barriers that are both patient and provider driven.

We propose to conduct a pilot study to evaluate the feasibility of establishing an insulin education group that would serve to educate patients about insulin, to initiate insulin in a group setting, and to provide appropriate follow-up of those who start insulin. If the intervention is successful, we plan to develop a multicenter study to test rigorously the effect of this approach.

Specific Aims:

To determine if psychological barriers to insulin initiation in patients with uncontrolled type 2 diabetes are favorably affected by a group insulin education and insulin initiation visit, as measured by the Barriers to Insulin Treatment (BIT) Questionaire before and after the intervention.

To evaluate the feasibility of the intervention as measured by the percent of patients who are referred to the class, but either cancel without rescheduling or fail to report and the percent of patients who begin insulin.

To evaluate the safety of the intervention as measured by the proportion of patients experiencing hypoglycemic symptoms; proportion of patients requiring sugar intake to manage hypoglycemia; and the proportion of patients requiring assistance to manage hypoglycemia.

Eligibility criteria: Inclusion Criteria:

* Primary care patient at McGuire Veterans Affairs Medical Center in Richmond, Virginia
* Age \> 18 years
* Inadequately controlled diabetes (HbA1c \> 8.0%) and not on insulin (using most recent HbA1c, within 1 month of the first visit)
* Primary Care Provider referral to insulin initiation/education group
* Patient brings home glucose readings to first visit

Exclusion Criteria:

* Patient is reluctant to participate in a group visit for any reason
* Patient unwilling to sign consent form

Primary outcomes:
measure: Change in "Barriers to Insulin Treatment (BIT)" Score From Before to After the Classes
timeFrame: 2 weeks
measure: Barriers to Insulin Treatment Total Sum Score Visit 1 (Week 0)
timeFrame: Visit 1 (week 0)
measure: Barriers to Insulin Treatment Total Sum Score Visit 2 (Week 2)
timeFrame: Visit 2 (week 2)
Secondary outcomes:
measure: Percent of Patients Who Begin Insulin
timeFrame: 2 weeks
measure: Number of Subjects Experiencing Hypoglycemic Symptoms
timeFrame: 2 weeks
measure: Number of Patients Experiencing a Severe Hypoglycemic Event
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Hunter Holmes McGuire VA Medical Center
state: Virginia
Study officials:
affiliation: Hunter Holmes McGuire VA Medical Center
name: Sonja K Fredrickson, MD
role: PRINCIPAL_INVESTIGATOR
References: