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

21. november 2014 opdateret af: Sunnybrook Health Sciences Centre
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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1592

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Institute for Clinical Evaluative Sciences

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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:

      1. Macrovascular disease (silent myocardial infarction, or evidence of peripheral arterial, carotid or cerebrovascular disease)
      2. Microvascular disease (nephropathy or retinopathy)
      3. Family history of premature coronary or cerebrovascular disease in a first-degree relative
      4. Duration of diabetes > 15 years with age > 30 years

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Intervention
Andet: Værktøjskasse
Cardiovascular Disease Toolkit sendt af Canadian Diabetes Association til familielæger, som ledsager foråret/sommeren 2009-udgaven af ​​det kvartalsvise nyhedsbrev, Canadian Diabetes. (Sendt i juni 2009.) Værktøjssættet indeholder et resumé af udvalgte afsnit af praksisretningslinjerne rettet mod primære læger; en synopsis af nøglebudskaberne vedrørende risikoen for hjertekarsygdomme; et lamineret kort med en forenklet algoritme til kardiovaskulær risikovurdering og behandling; og en blok af afrivningsark til patienter med et værktøj til selvvurdering af kardiovaskulær risiko.
Andet: Styring
Andet: Control
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Patient is receiving a statin
Tidsramme: July 2009 to April 2010
July 2009 to April 2010

Sekundære resultatmål

Resultatmål
Tidsramme
Patient is receiving an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker
Tidsramme: July 2009 to April 2010
July 2009 to April 2010
A1c level
Tidsramme: Last observation between July 2009 and April 2010
Last observation between July 2009 and April 2010
Blood pressure level
Tidsramme: Last observation between July 2009 and April 2010
Last observation between July 2009 and April 2010
LDL-cholesterol level
Tidsramme: Last observation between July 2009 and April 2010
Last observation between July 2009 and April 2010
Total- to HDL-cholesterol ratio
Tidsramme: Last observation between July 2009 and April 2010
Last observation between July 2009 and April 2010
Body mass index
Tidsramme: Last observation between July 2009 and April 2010
Last observation between July 2009 and April 2010
Waist circumference
Tidsramme: Last observation between July 2009 and April 2010
Last observation between July 2009 and April 2010
Change in treatment recommended following an A1c level above 0.070
Tidsramme: At the next patient visit after the abnormal measurement
At the next patient visit after the abnormal measurement
Change in treatment recommended following a systolic blood pressure above 130 or a diastolic blood pressure above 80
Tidsramme: At the patient visit of the abnormal measurement
At the patient visit of the abnormal measurement
Change in treatment recommended following an LDL-cholesterol level above 2.0 mmol/L
Tidsramme: At the next patient visit after the abnormal measurement
At the next patient visit after the abnormal measurement

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sunnybrook Health Sciences Centre

Samarbejdspartnere

Unity Health Toronto
Institute for Clinical Evaluative Sciences

Efterforskere

  • Ledende efterforsker: Baiju R Shah, MD PhD, Institute for Clinical Evaluative Sciences

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 2010

Primær færdiggørelse (Faktiske)

1. maj 2011

Studieafslutning (Faktiske)

1. maj 2011

Datoer for studieregistrering

Først indsendt

2. december 2009

Først indsendt, der opfyldte QC-kriterier

3. december 2009

Først opslået (Skøn)

4. december 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

24. november 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. november 2014

Sidst verificeret

1. november 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Shah-1

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Kardiovaskulær sygdom

Kliniske forsøg med Værktøjskasse

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Poland

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner