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
  Purpose

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
Cardiovascular Diseases

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Diabetes Cardiovascular Risk-Evaluation: Targets and Essential Data for Commitment of Treatment (DETECT)

Resource links provided by NLM:


Further study details as provided by Technische Universität Dresden:

Biospecimen Retention:   Samples Without DNA

whole blood, serum


Enrollment: 55518
Study Start Date: September 2003
Study Completion Date: December 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Detailed Description:

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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
Criteria

Inclusion Criteria:

  • unselected primary care patients

Exclusion Criteria:

  • none
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01076608

Sponsors and Collaborators
Technische Universität Dresden
Johann Wolfgang Goethe University Hospitals
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
  More Information

Additional Information:
Publications:
Responsible Party: Prof. Dr. H-U.Wittchen, Institute for Clinical Psychology and Psychotherapy, Technical University of Dresden, Germany
ClinicalTrials.gov Identifier: NCT01076608     History of Changes
Other Study ID Numbers: 149092003
Study First Received: February 25, 2010
Last Updated: February 25, 2010
Health Authority: Germany: Ethics Commission

Keywords provided by Technische Universität Dresden:
primary care patients

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 21, 2014