Type 2 Diabetes Mellitus: New Approaches to Optimize Medical Care in General Practice

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

204 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2012-12-31

Brief Summary

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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

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Conditions

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Type 2 Diabetes Mellitus

Keywords

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prevention health services research

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control group

No telephone counseling + usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Telephone Counseling

Telephone counseling + usual care

Group Type EXPERIMENTAL

Telephone counseling

Intervention Type OTHER

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

Interventions

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Telephone counseling

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hermann Brenner, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

German Cancer Research Center

Locations

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Christoph Lücke, MD

Beilstein, Baden-Wurttemberg, Germany

Site Status

Andrea Walliser-Klöpfer, MD

Benningen am Neckar, Baden-Wurttemberg, Germany

Site Status

Nader Heydari, MD

Fellbach, Baden-Wurttemberg, Germany

Site Status