DETECT-Diabetes Cardiovascular Risk-Evaluation: Targets and Essential Data for Commitment of Treatment

Sponsor
Technische Universität Dresden (Other)
Overall Status
Completed
CT.gov ID
NCT01076608
Collaborator
Johann Wolfgang Goethe University Hospital (Other), Max-Planck-Institute of Psychiatry (Other), University of Magdeburg (Other), Medical University of Graz (Other), Universitätsklinikum Hamburg-Eppendorf (Other)
55,518
63

Study Details

Study Description

Brief Summary

Cardiovascular diseases are, along with cancer, the most frequent causes for mortality and morbidity in the industrialized nations. Numerous clinical efficient approaches to reduce the known risk factors have been introduced in clinical routine care; yet with quite limited success, e.g. modification of behavioral risk factors, drug treatment and the combination of both. On the population level only marginal changes have been demonstrated, i.e. the mortality from myocardial infarction and stroke remains high.

To answer questions about underlying factors, for this unsatisfactory status, we might profit tremendously from studies that examine the situation, where treatment of patients most frequently take place: in primary care. This approach pays attention to the General Practitioner's (GP) in their gate keeping function in health care. Information from primary care in particular is largely lacking as recently stated by the "Sachverständigenrat für die konzertierte Aktion im Gesundheitswesen" in 2001. The DETECT study has been designed to address these critical issues.

On 16th and 18th September 2003, 3,188 GPs completed a standardised assessment of the diagnostic and therapeutic profile of 55,518 unselected consecutive patients. All patients completed a questionnaire on their demographic data, their complaints, their illness history, their knowledge about selected diseases and their attitude towards those. A sub sample of 7,519 patients additionally attended a standardized laboratory screening program. In this screening the focus was on blood constituents connected with cardiovascular diseases and diabetes, including e. g. cholesterol, lipoproteins, triglycerides and HbA1c. These patients were assessed a second time in the follow up period after one year in 2004 and for a final time after completion of the five-year follow-up period.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    What kind of information will DETECT provide?

    1. From the cross sectional part (descriptive epidemiological part on 16th/18th September
    • Frequency, characteristics and severity of cardiovascular diseases, selected associated metabolic syndromes and atherosclerotic diseases and syndromes

    • Identification and determination of the proportion of patients with high-risk constellations (e.g., post myocardial infarction, associated morbidities, laboratory measures)

    • Rates of General Practitioners recognition, diagnostic and therapeutic profiles

    • Assessment of quality of care (comparison with guidelines)

    • Indicators of undertreatment, overtreatment and inadequate treatment

    1. From the longitudinal part
    Changes of laboratory parameters and diagnoses after one and five years, in relation to:
    • Initial diagnostic and therapeutic status

    • Selected intervention criteria

    • Composition of risk indicators, and comparison with existing indices (PROCAM, Framingham, Score etc.)

    • Measurement of frequency and point of critical outcomes e.g., myocardial infarction, associated morbidity, hospitalisation, critical medical interventions

    • Significance of established and "new" cardiovascular risk factors

    • Prognostic value of biomarkers for risk stratification

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    55518 participants
    Observational Model:
    Ecologic or Community
    Time Perspective:
    Prospective
    Official Title:
    Diabetes Cardiovascular Risk-Evaluation: Targets and Essential Data for Commitment of Treatment (DETECT)
    Study Start Date :
    Sep 1, 2003
    Actual Primary Completion Date :
    Sep 1, 2008
    Actual Study Completion Date :
    Dec 1, 2008

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      Yes
      Inclusion Criteria:
      • unselected primary care patients
      Exclusion Criteria:
      • none

      Contacts and Locations

      Locations

      No locations specified.

      Sponsors and Collaborators

      • Technische Universität Dresden
      • Johann Wolfgang Goethe University Hospital
      • Max-Planck-Institute of Psychiatry
      • University of Magdeburg
      • Medical University of Graz
      • Universitätsklinikum Hamburg-Eppendorf

      Investigators

      • Principal Investigator: Hans-Ullrich Wittchen, Prof. Dr., Director of the Institute of Clinical Psychology and Psychotherapy at the Technical University of Dresden

      Study Documents (Full-Text)

      None provided.

      More Information

      Additional Information:

      Publications

      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT01076608
      Other Study ID Numbers:
      • 149092003
      First Posted:
      Feb 26, 2010
      Last Update Posted:
      Feb 26, 2010
      Last Verified:
      Feb 1, 2010
      Keywords provided by , ,
      Additional relevant MeSH terms:

      Study Results

      No Results Posted as of Feb 26, 2010