Do Group Insulin Education Visits Reduce Barriers to Insulin Initiation?
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Insulin Education Class
Sponsored by

About this trial
This is an interventional health services research trial for Diabetes Mellitus, Type 2 focused on measuring insulin, teaching
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
Sites / Locations
- Hunter Holmes McGuire VA Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Insulin Education Class Participants
Arm Description
Participation in an insulin educational class at week 0 and again at week 2
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Percent of Patients Who Begin Insulin
Number of Subjects Experiencing Hypoglycemic Symptoms
Number of subjects who reported subjective symptoms of hypoglycemia in the two weeks between study visits
Number of Patients Experiencing a Severe Hypoglycemic Event
Severe hypoglycemia is defined as requiring the help of another person to treat the hypoglycemia
Full Information
NCT ID
NCT00645528
First Posted
March 21, 2008
Last Updated
May 6, 2015
Sponsor
US Department of Veterans Affairs
1. Study Identification
Unique Protocol Identification Number
NCT00645528
Brief Title
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
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
insulin, teaching
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Insulin Education Class Participants
Arm Type
Experimental
Arm Description
Participation in an insulin educational class at week 0 and again at week 2
Intervention Type
Other
Intervention Name(s)
Insulin Education Class
Intervention Description
Participation in an Insulin Education Class at week 0 and week 2
Primary Outcome Measure Information:
Title
Change in "Barriers to Insulin Treatment (BIT)" Score From Before to After the Classes
Description
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.
Time Frame
2 weeks
Title
Barriers to Insulin Treatment Total Sum Score Visit 1 (Week 0)
Description
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.
Time Frame
Visit 1 (week 0)
Title
Barriers to Insulin Treatment Total Sum Score Visit 2 (Week 2)
Description
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.
Time Frame
Visit 2 (week 2)
Secondary Outcome Measure Information:
Title
Percent of Patients Who Begin Insulin
Time Frame
2 weeks
Title
Number of Subjects Experiencing Hypoglycemic Symptoms
Description
Number of subjects who reported subjective symptoms of hypoglycemia in the two weeks between study visits
Time Frame
2 weeks
Title
Number of Patients Experiencing a Severe Hypoglycemic Event
Description
Severe hypoglycemia is defined as requiring the help of another person to treat the hypoglycemia
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sonja K Fredrickson, MD
Organizational Affiliation
Hunter Holmes McGuire VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hunter Holmes McGuire VA Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
12. IPD Sharing Statement
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