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Clinical Trials/NCT00149331
NCT00149331CompletedPhase 4

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

Hamilton Health Sciences Corporation1 site in 1 country86 target enrollmentStarted: July 1, 2005Last updated:
Conditions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
86
Locations
1
Primary Endpoint
Preference for Insulin therapy

Study Overview

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?

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
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Educational Counseling Training
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Preference for Insulin therapy

Secondary Outcomes

  • Perceptions about insulin therapy
  • Perceptions about injection
  • Satisfaction with the education session

Investigators

Sponsor Class
Other

Study Sites (1)

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