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Completed

NCT Number: NCT01026688

Evaluation of a Toolkit to Improve Cardiovascular Disease Screening and Treatment for People With Type 2 Diabetes

Diabetes is a common and serious chronic disease. However, there is a large gap between the level of care that people should receive (based on research and guidelines) and the level of care they actually receive. With the release of their 2008 Clinical Practice Guidelines, the Canadian Diabetes Association has a strategy to improve heart disease screening and treatment for people with diabetes. This study will evaluate whether the strategy works. The focus of the strategy was to give all family physicians in Canada a Toolkit in June 2009 to help them delivery better care for their diabetic patients. In Ontario, only half of doctors received this Toolkit. We will compare the quality of care received by diabetic patients whose doctors received this Toolkit versus those who doctors did not.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute for Clinical Evaluative Sciences

Toronto, Ontario, M4N 3M5, Canada

About this study

A cardiovascular disease Toolkit was developed by the Canadian Diabetes Association and mailed to family physician with the Spring/Summer 2009 edition of the newsletter, Canadian Diabetes. The Toolkit was packaged in a brightly-coloured box with Canadian Diabetes Association branding, and contained: 1) an introductory letter from the Chair of the practice guidelines' Dissemination and Implementation Committee; 2) an eight page summary of selected sections of the practice guidelines targeted towards primary care physicians; 3) a four page synopsis of the key guideline elements pertaining to cardiovascular disease risk; 4) a small double-sided laminated card with a simplified algorithm for cardiovascular risk assessment, vascular protection strategies and screening for cardiovascular disease; and 5) a pad of tear-off sheets for patients with a cardiovascular risk self-assessment tool and a list of recommended risk reduction strategies.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient with diagnosed diabetes
  • Seen in the office of a participating family physician at least once between July 2009 and April 2010
  • At high risk for cardiovascular events:
  • Previous cardiovascular disease (including AMI, angina, stroke, TIA, claudication); or
  • Men aged >= 45 years, women aged >= 50 years; or
  • Men aged < 45 years, women aged < 50 years with at least one of the following:
  • Macrovascular disease (silent myocardial infarction, or evidence of peripheral arterial, carotid or cerebrovascular disease)
  • Microvascular disease (nephropathy or retinopathy)
  • Family history of premature coronary or cerebrovascular disease in a first-degree relative
  • Duration of diabetes > 15 years with age > 30 years

Treatment and study plan

Toolkit

Other

Cardiovascular Disease Toolkit mailed by the Canadian Diabetes Association to family physicians, accompanying the Spring/Summer 2009 edition of the quarterly newsletter, Canadian Diabetes. (Mailed in June 2009.) The Toolkit includes a summary of selected sections of the practice guidelines targeted towards primary care physicians; a synopsis of the key messages pertaining to cardiovascular disease risk; a laminated card with a simplified algorithm for cardiovascular risk assessment and treatment; and a pad of tear-off sheets for patients with a cardiovascular risk self-assessment tool.

Control

Other

The Spring/Summer 2009 issue of the quarterly newsletter, Canadian Diabetes, mailed on its own. The Cardiovascular Toolkit was mailed to Control arm physicians with the May 2010 issue of the newsletter.

Primary outcomes

  1. Patient is receiving a statin

    Time frame: July 2009 to April 2010

Secondary outcomes

  1. Patient is receiving an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker

    Time frame: July 2009 to April 2010

  2. A1c level

    Time frame: Last observation between July 2009 and April 2010

  3. Blood pressure level

    Time frame: Last observation between July 2009 and April 2010

  4. LDL-cholesterol level

    Time frame: Last observation between July 2009 and April 2010

  5. Total- to HDL-cholesterol ratio

    Time frame: Last observation between July 2009 and April 2010

  6. Body mass index

    Time frame: Last observation between July 2009 and April 2010

  7. Waist circumference

    Time frame: Last observation between July 2009 and April 2010

  8. Change in treatment recommended following an A1c level above 0.070

    Time frame: At the next patient visit after the abnormal measurement

  9. Change in treatment recommended following a systolic blood pressure above 130 or a diastolic blood pressure above 80

    Time frame: At the patient visit of the abnormal measurement

  10. Change in treatment recommended following an LDL-cholesterol level above 2.0 mmol/L

    Time frame: At the next patient visit after the abnormal measurement

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Collaborators

  • Institute for Clinical Evaluative Sciences
  • Unity Health Toronto

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Dec 4, 2009
Registry last updated
Nov 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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