Condition category
Nutritional, Metabolic, Endocrine
Date applied
22/06/2005
Date assigned
20/07/2005
Last edited
27/11/2007
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Joachim Szecsenyi

ORCID ID

Contact details

Vossstrasse 2
Heidelberg
69115
Germany
+49 6221 56 4745
joachim.szecsenyi@med.uni-heidelberg.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

ELSID

Study hypothesis

1. The German-Diabetes-Disease Management Program (DMP 1) is more effective than routine diabetes care (CG)
2. An optimally implemented form of the Diabetes-Disease Management Program (DMP 2) is more effective than the German-Diabetes-DMP(DMP 1).

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Not Specified

Patient information sheet

Condition

Type 2 diabetes

Intervention

Randomisation between DMP 1 and DMP 2.

GPs in the DMP 1 group will offer regular consultations at 3- or 6-month intervals including detailed diabetes-specific anamnesis, physical examination including taking blood pressure and analysis of HbA1c. Agreements are made concerning further treatment, eg target values for HbA1c and blood pressure and participation in patient education programmes for diabetes or hypertension. All medical findings and the current medication have to be documented within structured, standardized documentation sheets at each consultation. If required a referral to a specialist (eg ophthalmologist) will be arranged.

In addition, in the DMP 2 group the following interventions are planned: interactive quality circle meetings for the GPs, educational meetings for medical assistants in the practices, outreach visits including the practice team, homepage with 'best practice' examples.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

HbA1c and blood pressure.

Secondary outcome measures

Prescriptions, hospitalizations, referrals, severe complications, SCORE risk chart.

Overall trial start date

01/08/2005

Overall trial end date

31/07/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Control group: Practices and patients with type 2 diabetes not participating in a Diabetes-Disease Management Programme
DMP 1 and DMP 2 group: Practices and patients with type 2 diabetes participating in a Diabetes-Disease Management Programme

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

4000 patients

Participant exclusion criteria

Control group: Practices or Patients participating in any Disease Management Programmes

Recruitment start date

01/08/2005

Recruitment end date

31/07/2008

Locations

Countries of recruitment

Germany

Trial participating centre

Vossstrasse 2
Heidelberg
69115
Germany

Sponsor information

Organisation

AOK-Bundesverband (Germany)

Sponsor details

Kortrijker Strasse 1
Bonn
53177
Germany
+49 228 843 0
info@bv.aok.de

Sponsor type

Industry

Website

http://www.aok-bv.de

Funders

Funder type

Industry

Funder name

AOK-Bundesverband

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Rationale, design and conduct: http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=16202151

Publication citations

  1. Joos S, Rosemann T, Heiderhoff M, Wensing M, Ludt S, Gensichen J, Kaufmann-Kolle P, Szecsenyi J, ELSID-Diabetes study-evaluation of a large scale implementation of disease management programmes for patients with type 2 diabetes. Rationale, design and conduct--a study protocol [ISRCTN08471887]., BMC Public Health, 2005, 5, 99, doi: 10.1186/1471-2458-5-99.

Additional files

Editorial Notes