NCT00149331

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for phase_4 type-2-diabetes

Timeline
Completed

Started Jul 2005

Shorter than P25 for phase_4 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

September 11, 2006

Status Verified

September 1, 2006

First QC Date

September 6, 2005

Last Update Submit

September 7, 2006

Conditions

Type 2 Diabetes

Keywords

Diabetes, Insulin, Education

Outcome Measures

Primary Outcomes (1)

  • Preference for Insulin therapy

Secondary Outcomes (3)

  • Perceptions about insulin therapy

  • Perceptions about injection

  • Satisfaction with the education session

Interventions

Structured education programBEHAVIORAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamilton Health Sciences - Henderson Site

Hamilton, Ontario, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes MellitusInsulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Study Officials

  • Lisa Dolovich, PharmD MSc

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
ECT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 8, 2005

Study Start

July 1, 2005

Study Completion

March 1, 2006

Last Updated

September 11, 2006

Record last verified: 2006-09

Locations

CA(1)