Do Group Insulin Education Visits Reduce Barriers to Insulin Initiation?

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Do Group Insulin Education Visits Reduce Barriers to Insulin Initiation?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00645528
• Other study ID #: SHP 08-198
• Status: Completed
• Phase: N/A
• First received: March 21, 2008
• Last updated: May 6, 2015
• Start date: April 2008
• Est. completion date: September 2008

Study information

• Verified date: May 2015
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: September 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Other:
• Insulin Education Class
Participation in an Insulin Education Class at week 0 and week 2

Locations

Country	Name	City	State
United States	Hunter Holmes McGuire VA Medical Center	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in "Barriers to Insulin Treatment (BIT)" Score From Before to After the Classes	The Barriers to Insulin Treatment Questionnaire (BIT) was completed at the start of the first visit and at the end of the second visit. The BIT is a 14 item self-administered questionnaire with 5 subscales, each representing a different psychological barrier to insulin treatment. Scales are scored 1-10, representing the mean answer of the 10-point Likert questions for the relevant scale. The higher the score, the greater the barriers to insulin treatment, with the exception of the 2nd scale ("Expectations regarding positive insulin-related outcomes") where the lower the score, the greater the barriers to insulin treatment. An overall sum score is calculated the same way, after inverting the items of the 2nd scale. The overall sum scale is scored 1-10, representing the mean answers of the 10-point Likert questions. The higher the score, the greater the barriers to insulin treatment. Reported here is the change in BIT score from baseline. This was assessed by paired t-test.	2 weeks	No
Primary	Barriers to Insulin Treatment Total Sum Score Visit 1 (Week 0)	The Barriers to Insulin Treatment Questionnaire (BIT) was completed at the start of the first visit and at the end of the second visit. The BIT is a 14 item self-administered questionnaire with 5 subscales, each representing a different psychological barrier to insulin treatment. Scales are scored 1-10, representing the mean answer of the 10 point Likert questions for the relevant scale. The higher the score, the greater the barriers to insulin treatment, with the exception of the 2nd scale ("Expectations regarding positive insulin-related outcomes") where the lower the score, the greater the barriers to insulin treatment. An overall sum score can be calculated the same way, after inverting the items of the 2nd scale. The overall sum scale is scored 1-10, representing the mean answers of the 10-point Likert questions. The higher the score, the greater the barriers to insulin treatment. The Total Sum Score and each subscale at Visit 1 is reported here.	Visit 1 (week 0)	No
Primary	Barriers to Insulin Treatment Total Sum Score Visit 2 (Week 2)	The Barriers to Insulin Treatment Questionnaire (BIT) was completed at the start of the first visit and at the end of the second visit. The BIT is a 14 item self-administered questionnaire with 5 subscales, each representing a different psychological barrier to insulin treatment. Scales are scored 1-10, representing the mean answer of the 10-point Likert questions for the relevant scale. The higher the score, the greater the barriers to insulin treatment, with the exception of the 2nd scale ("Expectations regarding positive insulin-related outcomes") where the lower the score, the greater the barriers to insulin treatment. An overall sum score is calculated the same way, after inverting the items of the 2nd scale. The overall sum scale is scored 1-10, representing the mean answers of the 10-point Likert questions. The higher the score, the greater the barriers to insulin treatment. The Total Sum Score and each subscale at Visit 2 is reported here.	Visit 2 (week 2)	No
Secondary	Percent of Patients Who Begin Insulin		2 weeks	No
Secondary	Number of Subjects Experiencing Hypoglycemic Symptoms	Number of subjects who reported subjective symptoms of hypoglycemia in the two weeks between study visits	2 weeks	Yes
Secondary	Number of Patients Experiencing a Severe Hypoglycemic Event	Severe hypoglycemia is defined as requiring the help of another person to treat the hypoglycemia	2 weeks	Yes