NCT00210262

Brief Summary

Diabetes mellitus (DM) imposes a significant burden of early mortality and decreased quality of life on the 6% of Canadians affected by it. There is a growing body of research evidence showing that the use of certain medications (ACE inhibitors, blood pressure medications and cholesterol lowering agents) can reduce the major complications of diabetes such as heart, blood vessel and kidney disease and amputations. Unfortunately this research knowledge does not appear to be routinely translated into clinical practice. The proposed study examines the effect of simple mailed interventions to patients or physicians on improving the use of these therapies. The strategies to be tested are direct patient education with an emphasis on blood pressure and lipid control rather than use of particular drugs and, for physicians, the provision of confidential prescribing feedback together with targeted educational bulletins. With patient and physician consent, health care administrative data will be used to examine the impact of the interventions. If successful, the study will identify low cost reproducible interventions to promote the use of proven preventive therapies in clinical practice.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Oct 2002

Typical duration for not_applicable 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
Last Updated

September 21, 2005

Status Verified

November 1, 2003

First QC Date

September 15, 2005

Last Update Submit

September 15, 2005

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

  • rate of ACE inhibitor use in index patients

Secondary Outcomes (7)

  • rate of ACE inhibitor use in all patients

  • Rate of lipid-lowering drug use in index patients

  • Rate of lipid-lowering drug use in all patients

  • Rate of use of 2 or more antihypertensives in index patients

  • Rate of use of 2 or more antihypertensives in all patients

  • +2 more secondary outcomes

Interventions

Feedback and EducationBEHAVIORAL

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • age \>65 years
  • consent
  • within the practices of participating primary care physicians

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ICES

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Janet E. Hux, MD, SM

    ICES

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
ECT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 15, 2005

First Posted

September 21, 2005

Study Start

October 1, 2002

Study Completion

January 1, 2005

Last Updated

September 21, 2005

Record last verified: 2003-11

Locations

CA(1)