NCT00742547

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
204

participants targeted

Target at P75+ for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Oct 2008

Longer than P75 for not_applicable type-2-diabetes-mellitus

Geographic Reach
1 country

37 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 27, 2008

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2008

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

December 11, 2013

Status Verified

December 1, 2013

Enrollment Period

3.8 years

First QC Date

August 26, 2008

Last Update Submit

December 10, 2013

Conditions

Type 2 Diabetes Mellitus

Keywords

preventionhealth services research

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    18 months

Secondary Outcomes (6)

  • hospitalization

    18 month

  • CHD, mortality

    18 months

  • lipid metabolism control

    18 months

  • risk factor control (eg. body weight, physical activity, smoking)

    18 months

  • health-related quality of life

    18 months

  • +1 more secondary outcomes

Study Arms (2)

Control group

NO INTERVENTION

No telephone counseling + usual care

Telephone Counseling

EXPERIMENTAL

Telephone counseling + usual care

Other: Telephone counseling

Interventions

Telephone counselingOTHER

Telephone counseling is provided once a month by the medical secretary of the general practitioner's practices

Telephone Counseling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (37)

Christoph Lücke, MD

Beilstein, Baden-Wurttemberg, 71717, Germany

Location

Andrea Walliser-Klöpfer, MD

Benningen am Neckar, Baden-Wurttemberg, 71724, Germany

Location

Nader Heydari, MD

Fellbach, Baden-Wurttemberg, 70737, Germany

Location

Adelheid Halttunen, MD

Gemmingen, Baden-Wurttemberg, 75050, Germany

Location

Hans-Joachim Essich, MD

Heilbronn, Baden-Wurttemberg, 74072, Germany

Location

Jürgen Wollweber, MD

Heilbronn, Baden-Wurttemberg, 74072, Germany

Location

Volker Naser, MD

Heilbronn, Baden-Wurttemberg, 74076, Germany

Location

Andreas Wößner, MD

Heilbronn, Baden-Wurttemberg, 74078, Germany

Location

Ullrich Barthelmes, MD

Heilbronn, Baden-Wurttemberg, 74080, Germany

Location

Axel Möller, MD

Heilbronn, Baden-Wurttemberg, 74081, Germany

Location

Miroslaw Wyszynski, MD

Heilbronn, Baden-Wurttemberg, 74081, Germany

Location

Ulrich Hofmann, MD

Ilsfeld-Auenstein, Baden-Wurttemberg, 74360, Germany

Location

Hans Martin Schweizer, MD

Korntal, Baden-Wurttemberg, 70825, Germany

Location

Eberhard Rieker, MD

Lauffen am Neckar, Baden-Wurttemberg, 74348, Germany

Location

Bernd Leuchs, MD

Leonberg, Baden-Wurttemberg, 71229, Germany

Location

Gerhard Günther, MD

Leonberg, Baden-Wurttemberg, 71229, Germany

Location

Thomas Baartz, MD

Leonberg, Baden-Wurttemberg, 71229, Germany

Location

Monika Muhler, MD

Löwenstein, Baden-Wurttemberg, 74245, Germany

Location

Ulrich Wagner, MD

Ludwigsburg, Baden-Wurttemberg, 71634, Germany

Location

Martin Heinrich, MD

Ludwigsburg, Baden-Wurttemberg, 71640, Germany

Location

Franz Lang, MD

Marbach am Neckar, Baden-Wurttemberg, 71672, Germany

Location

Jürgen Wirth, MD

Marbach am Neckar, Baden-Wurttemberg, 71672, Germany

Location

Alfred Preisner, MD

Massenbachhausen, Baden-Wurttemberg, 74252, Germany

Location

Michael Spiel, MD

Murr, Baden-Wurttemberg, 71711, Germany

Location

Hans-Jürgen Sommerer, MD

Neckarsulm, Baden-Wurttemberg, 74081, Germany

Location

Dietmar Kunz, MD

Neckarsulm, Baden-Wurttemberg, 74172, Germany

Location

Hartmut Jungjohann, MD

Neckarsulm, Baden-Wurttemberg, 74172, Germany

Location

Jürgen Herbers, MD

Pleidelsheim, Baden-Wurttemberg, 74385, Germany

Location

Ulf-Michael Werner, MD

Remshalden, Baden-Wurttemberg, 73630, Germany

Location

Frank Röder, MD

Schwaikheim, Baden-Wurttemberg, 71409, Germany

Location

Gisela Gramlich, MD

Untergruppenbach, Baden-Wurttemberg, 74199, Germany

Location

Ildiko Tasic

Vaihingen-Enz, Baden-Wurttemberg, 71665, Germany

Location

Karl Schütz, MD

Weinsberg, Baden-Wurttemberg, 74189, Germany

Location

Sigmund Jakob

Weinsberg, Baden-Wurttemberg, 74189, Germany

Location

Kurt Weber, MD

Weissach, Baden-Wurttemberg, 71287, Germany

Location

Dietmar Zinßer, MD

Winnenden, Baden-Wurttemberg, 71364, Germany

Location

Odilo Schnabel, MD

Zaberfeld, Baden-Wurttemberg, 74374, Germany

Location

Related Publications (2)

  • Mons U, Raum E, Kramer HU, Ruter G, Rothenbacher D, Rosemann T, Szecsenyi J, Brenner H. Effectiveness of a supportive telephone counseling intervention in type 2 diabetes patients: randomized controlled study. PLoS One. 2013 Oct 30;8(10):e77954. doi: 10.1371/journal.pone.0077954. eCollection 2013.

    PMID: 24205043DERIVED

  • Kramer HU, Raum E, Ruter G, Schottker B, Rothenbacher D, Rosemann T, Szecsenyi J, Brenner H. Gender disparities in diabetes and coronary heart disease medication among patients with type 2 diabetes: results from the DIANA study. Cardiovasc Diabetol. 2012 Jul 27;11:88. doi: 10.1186/1475-2840-11-88.

    PMID: 22838970DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Hermann Brenner, MD, MPH

    German Cancer Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2008

First Posted

August 27, 2008

Study Start

October 1, 2008

Primary Completion

July 1, 2012

Study Completion

December 1, 2012

Last Updated

December 11, 2013

Record last verified: 2013-12

Locations

DE(37)