Clinical trial NCT01076608: DETECT-Diabetes Cardiovascular Risk-Evaluation: Targets and Essential Data for Commitment of Treatment
Official title: Diabetes Cardiovascular Risk-Evaluation: Targets and Essential Data for Commitment of Treatment (DETECT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Keywords: primary care patients
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
Collaborators: name: Johann Wolfgang Goethe University Hospital
name: Max-Planck-Institute of Psychiatry
name: University of Magdeburg
name: Medical University of Graz
name: Universitätsklinikum Hamburg-Eppendorf
First posted: 2010-02-26
Enrollment: 55518
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
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

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.

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 criteria: Inclusion Criteria:

* unselected primary care patients

Exclusion Criteria:

* none

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Director of the Institute of Clinical Psychology and Psychotherapy at the Technical University of Dresden
name: Hans-Ullrich Wittchen, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wittchen HU, Glaesmer H, Marz W, Stalla G, Lehnert H, Zeiher AM, Silber S, Koch U, Bohler 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. doi: 10.1185/030079905X38187.