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

This study has been completed.
Sponsor:
Collaborators:
Johann Wolfgang Goethe University Hospitals
Max-Planck-Institute of Psychiatry
University of Magdeburg
Medical University of Graz
Universitätsklinikum Hamburg-Eppendorf
Information provided by:
Technische Universität Dresden
ClinicalTrials.gov Identifier:
NCT01076608
First received: February 25, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted

February 25, 2010
February 25, 2010
September 2003
September 2008   (final data collection date for primary outcome measure)
Not Provided
Not Provided
No Changes Posted
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DETECT-Diabetes Cardiovascular Risk-Evaluation: Targets and Essential Data for Commitment of Treatment
Diabetes Cardiovascular Risk-Evaluation: Targets and Essential Data for Commitment of Treatment (DETECT)

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.

What kind of information will DETECT provide?

I. From the cross sectional part (descriptive epidemiological part on 16th/18th September 2003)

  • 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

II. 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
Observational
Observational Model: Ecologic or Community
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

whole blood, serum

Probability Sample

Representative random sample of 3188 General Practitioners in Germany (general practitioners and internists serving as GPs), who included patients:

  • Main study: 55,518 (unselected consecutive)
  • Longitudinal observation study in a random subset of 7519 patients
Cardiovascular Diseases
Not Provided
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Wittchen HU, Glaesmer H, März W, Stalla G, Lehnert H, Zeiher AM, Silber S, Koch U, Böhler S, Pittrow D, Ruf G; DETECT-Study Group. Cardiovascular risk factors in primary care: methods and baseline prevalence rates--the DETECT program. Curr Med Res Opin. 2005 Apr;21(4):619-30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55518
December 2008
September 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • unselected primary care patients

Exclusion Criteria:

  • none
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01076608
149092003
Yes
Prof. Dr. H-U.Wittchen, Institute for Clinical Psychology and Psychotherapy, Technical University of Dresden, Germany
Technische Universität Dresden
  • Johann Wolfgang Goethe University Hospitals
  • Max-Planck-Institute of Psychiatry
  • University of Magdeburg
  • Medical University of Graz
  • Universitätsklinikum Hamburg-Eppendorf
Principal Investigator: Hans-Ullrich Wittchen, Prof. Dr. Director of the Institute of Clinical Psychology and Psychotherapy at the Technical University of Dresden
Technische Universität Dresden
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP