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The Effects of Two Education Strategies About Insulin on Patient Preferences and Perceptions About Insulin Therapy

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ClinicalTrials.gov Identifier: NCT00149331
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : September 11, 2006
Sponsor:
Information provided by:

Study Description
Brief Summary:

This study compared the impact of two educational strategies (an education program versus a pamphlet) on participants preferences for insulin and their perceptions about insulin and injections after attending an educational session with a diabetes educator about insulin.

Main research question: Among adults with type 2 diabetes who are potential candidates for insulin therapy, does an education strategy that involves a personal letter from the family physician, a presentation about insulin, and information about giving an injection, versus a pamphlet education strategy, effect: preference to accept insulin therapy; perceptions about insulin therapy; or perception about the injection?


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Behavioral: Structured education program Phase 4

Detailed Description:
Many people with type 2 diabetes who need insulin therapy are often reluctant to start using insulin to manage their diabetes. This may be because they are worried about giving an injection and do not know enough about insulin to make an informed choice. This research is important because it will help researchers and health care providers better understand the feelings and educational support that patients need when they are thinking about starting insulin. This can help health care providers to better tailor the care they give to patients.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Educational/Counseling/Training
Official Title: A Randomized Controlled Trial Comparing the Effects of Two Education Strategies About Insulin on Preferences and Perceptions About Insulin Therapy
Study Start Date : July 2005
Estimated Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Preference for Insulin therapy

Secondary Outcome Measures :
  1. Perceptions about insulin therapy
  2. Perceptions about injection
  3. Satisfaction with the education session

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 18 years of age
  • Have a diagnosis of type 2 diabetes mellitus in their medical chart
  • Have suboptimal glycosylated hemoglobin (HgA1c > 7.5%) recorded in their chart as the most recent lab result
  • Currently perform self-monitoring of blood glucose
  • Able to understand written and spoken English

Exclusion Criteria:

  • Are currently using, or have previously used insulin
  • Have cognitive, visual, hearing or other medical impairment
  • Have terminal malignancies or dementia
  • Have psychiatric illness not controlled with medications
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00149331


Locations
Canada, Ontario
Hamilton Health Sciences - Henderson Site
Hamilton, Ontario, Canada
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Investigators
Principal Investigator: Lisa Dolovich, PharmD MSc McMaster University
More Information

ClinicalTrials.gov Identifier: NCT00149331     History of Changes
Other Study ID Numbers: 04-2429
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: September 11, 2006
Last Verified: September 2006

Keywords provided by McMaster University:
Diabetes, Insulin, Education

Additional relevant MeSH terms:
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs