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

Type 2 Diabetes Clinical Trial

Official title:

A Randomized Controlled Trial Comparing the Effects of Two Education Strategies About Insulin on Preferences and Perceptions About Insulin Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00149331
• Other study ID #: 04-2429
• Status: Completed
• Phase: Phase 4
• First received: September 6, 2005
• Last updated: September 7, 2006
• Start date: July 2005
• Est. completion date: March 2006

Study information

• Verified date: September 2006
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Behavioral:
• Structured education program

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences - Henderson Site	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preference for Insulin therapy
Secondary	Perceptions about insulin therapy
Secondary	Perceptions about injection
Secondary	Satisfaction with the education session