Do Group Insulin Education Visits Reduce Barriers to Insulin Initiation?

NCT00645528 | Completed Results

• 1 other identifier: SHP 08-198
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

insulin; teaching

Outcome Measures

Primary Outcomes (3)

• 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

• 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)

• 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)

Secondary Outcomes (3)

• Percent of Patients Who Begin Insulin

  2 weeks

• Number of Subjects Experiencing Hypoglycemic Symptoms

  2 weeks

• Number of Patients Experiencing a Severe Hypoglycemic Event

  2 weeks

Study Arms (1)

Insulin Education Class Participants

EXPERIMENTAL

Participation in an insulin educational class at week 0 and again at week 2

Other: Insulin Education Class

Interventions

Insulin Education Class OTHER

Participation in an Insulin Education Class at week 0 and week 2

Insulin Education Class Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, 23249, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Limitations and Caveats

This was a pilot study. Limitations include the small sample size and lack of a control group.

Results Point of Contact

• Title: Sonja K Fredrickson, MD
• Organization: Hunter Holmes McGuire VA Medical Center

sonja.fredrickson@va.gov

804-675-5151

Study Officials

• Sonja K Fredrickson, MD

  Hunter Holmes McGuire VA Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2008
• First Posted: March 27, 2008
• Study Start: April 1, 2008
• Primary Completion: August 1, 2008
• Study Completion: September 1, 2008
• Last Updated: May 8, 2015
• Results First Posted: May 8, 2015

Record last verified: 2015-05

Locations

US (1)