The Effects of Two Education Strategies About Insulin on Patient Preferences and Perceptions About Insulin Therapy - Full Text View

Sponsored by:	Hamilton Health Sciences
Information provided by:	McMaster University
ClinicalTrials.gov Identifier:	NCT00149331

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 IV

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Educational/Counseling/Training, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomized Controlled Trial Comparing the Effects of Two Education Strategies About Insulin on Preferences and Perceptions About Insulin Therapy

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

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

Investigators

Principal Investigator:

Lisa Dolovich, PharmD MSc

McMaster University

More Information

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

Keywords provided by McMaster University:

Diabetes, Insulin, Education

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009