Do Group Insulin Education Visits Reduce Barriers to Insulin Initiation?

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00645528
First received: March 21, 2008
Last updated: July 2, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention
Diabetes Mellitus, Type 2
Other: Group Education

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Do Group Insulin Education Visits Reduce Barriers to Insulin Initiation?

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Change in "Barriers to Insulin Treatment (BIT)" score from before to after the classes [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent of patients who begin insulin [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients experiencing hypoglycemic symptoms; proportion of patients requiring sugar intake to manage hypoglycemia; proportion of patients requiring assistance to manage hypoglycemia [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
  • Percent of patients who are referred to the class, but either cancel without rescheduling or fail to report [ Time Frame: 2-4 weeks ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: April 2008
Study Completion Date: September 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Participation in an insulin educational class
Other: Group Education
Participation in an insulin educational class

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00645528

Locations
United States, Virginia
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, United States, 23249
Sponsors and Collaborators
Investigators
Principal Investigator: Sonja F Fredrickson, MD Hunter Holmes McGuire VA Medical Center
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00645528     History of Changes
Other Study ID Numbers: SHP 08-198
Study First Received: March 21, 2008
Last Updated: July 2, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
insulin
teaching

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014