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

This study has been completed.
Sponsor:
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00149331
First received: September 6, 2005
Last updated: September 7, 2006
Last verified: September 2006
  Purpose

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 Intervention Phase
Type 2 Diabetes
Behavioral: Structured education program
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Preference for Insulin therapy

Secondary Outcome Measures:
  • Perceptions about insulin therapy
  • Perceptions about injection
  • Satisfaction with the education session

Estimated Enrollment: 86
Study Start Date: July 2005
Estimated Study Completion Date: March 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00149331     History of Changes
Other Study ID Numbers: 04-2429
Study First Received: September 6, 2005
Last Updated: September 7, 2006
Health Authority: Canada: Health Canada

Keywords provided by McMaster University:
Diabetes, Insulin, Education

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 August 21, 2014