Type 2 Diabetes Mellitus: New Approaches to Optimize Medical Care in General Practice
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Other: Telephone counseling
- Registration Number
- NCT00742547
- Lead Sponsor
- German Cancer Research Center
- Brief Summary
Patients with type-2 diabetes mellitus have an higher risk developing secondary disorders. In an epidemiological longitudinal study of about 1.150 patients with type 2 diabetes mellitus we investigate determinants and predictors for long-term prognosis. The patients are recruited and supervised in practices of general practitioners of the administrative district of Ludwigsburg/Heilbronn (Baden-Württemberg, Germany). In a subgroup of about 200 patients with a dissatisfactory metabolic status (HbA1c \> 7,5%) a randomised interventional study is performed. The intervention comprises a telephone counseling by the medical secretary of each practice executed in a predefined period of time. The outcome parameters of interest are the change of HbA1c, the development of secondary disorders and adverse events, quality of life and risk factor control, as well as hospitalization and mortality.
The aim of the study was to develop an patient-centred instrument implementable in the routine medical care in order to enhance the prognosis of patients with type-2 diabetes mellitus.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 204
- Patient with type-2 diabetes mellitus attending the general practitioner's in the time from October to December 2008
- Ability to take part in the study
- Nursing home resident
- Insufficient knowledge of the German language
- Palliative health care with limited life expectancy
- Emergency outpatient
- All outpatients who attend the general practitioner by way of exception
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Telephone Counseling Telephone counseling Telephone counseling + usual care
- Primary Outcome Measures
Name Time Method HbA1c 18 months
- Secondary Outcome Measures
Name Time Method CHD, mortality 18 months health-related quality of life 18 months lipid metabolism control 18 months risk factor control (eg. body weight, physical activity, smoking) 18 months hospitalization 18 month incidence of diabetes-related complications 18 months
Trial Locations
- Locations (37)
Bernd Leuchs, MD
🇩🇪Leonberg, Baden-Württemberg, Germany
Jürgen Wollweber, MD
🇩🇪Heilbronn, Baden-Württemberg, Germany
Volker Naser, MD
🇩🇪Heilbronn, Baden-Württemberg, Germany
Ulrich Wagner, MD
🇩🇪Ludwigsburg, Baden-Württemberg, Germany
Martin Heinrich, MD
🇩🇪Ludwigsburg, Baden-Württemberg, Germany
Franz Lang, MD
🇩🇪Marbach am Neckar, Baden-Württemberg, Germany
Alfred Preisner, MD
🇩🇪Massenbachhausen, Baden-Württemberg, Germany
Hans-Jürgen Sommerer, MD
🇩🇪Neckarsulm, Baden-Württemberg, Germany
Dietmar Kunz, MD
🇩🇪Neckarsulm, Baden-Württemberg, Germany
Ulf-Michael Werner, MD
🇩🇪Remshalden, Baden-Württemberg, Germany
Kurt Weber, MD
🇩🇪Weissach, Baden-Württemberg, Germany
Dietmar Zinßer, MD
🇩🇪Winnenden, Baden-Württemberg, Germany
Ullrich Barthelmes, MD
🇩🇪Heilbronn, Baden-Württemberg, Germany
Andrea Walliser-Klöpfer, MD
🇩🇪Benningen am Neckar, Baden-Württemberg, Germany
Hans Martin Schweizer, MD
🇩🇪Korntal, Baden-Württemberg, Germany
Eberhard Rieker, MD
🇩🇪Lauffen am Neckar, Baden-Württemberg, Germany
Nader Heydari, MD
🇩🇪Fellbach, Baden-Württemberg, Germany
Adelheid Halttunen, MD
🇩🇪Gemmingen, Baden-Württemberg, Germany
Hans-Joachim Essich, MD
🇩🇪Heilbronn, Baden-Württemberg, Germany
Axel Möller, MD
🇩🇪Heilbronn, Baden-Württemberg, Germany
Miroslaw Wyszynski, MD
🇩🇪Heilbronn, Baden-Württemberg, Germany
Ildiko Tasic
🇩🇪Vaihingen-Enz, Baden-Württemberg, Germany
Ulrich Hofmann, MD
🇩🇪Ilsfeld-Auenstein, Baden-Württemberg, Germany
Monika Muhler, MD
🇩🇪Loewenstein, Baden-Württemberg, Germany
Michael Spiel, MD
🇩🇪Murr, Baden-Württemberg, Germany
Gerhard Günther, MD
🇩🇪Leonberg, Baden-Württemberg, Germany
Thomas Baartz, MD
🇩🇪Leonberg, Baden-Württemberg, Germany
Jürgen Wirth, MD
🇩🇪Marbach am Neckar, Baden-Württemberg, Germany
Jürgen Herbers, MD
🇩🇪Pleidelsheim, Baden-Württemberg, Germany
Frank Röder, MD
🇩🇪Schwaikheim, Baden-Württemberg, Germany
Gisela Gramlich, MD
🇩🇪Untergruppenbach, Baden-Württemberg, Germany
Hartmut Jungjohann, MD
🇩🇪Neckarsulm, Baden-Württemberg, Germany
Sigmund Jakob
🇩🇪Weinsberg, Baden-Württemberg, Germany
Odilo Schnabel, MD
🇩🇪Zaberfeld, Baden-Württemberg, Germany
Karl Schütz, MD
🇩🇪Weinsberg, Baden-Württemberg, Germany
Christoph Lücke, MD
🇩🇪Beilstein, Baden-Württemberg, Germany
Andreas Wößner, MD
🇩🇪Heilbronn, Baden-Württemberg, Germany