Condition category
Nutritional, Metabolic, Endocrine
Date applied
06/06/2007
Date assigned
12/07/2007
Last edited
23/02/2012
Prospective/Retrospective
Retrospectively 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 Andreas Sönnichsen

ORCID ID

Contact details

Strubergasse 21
Salzburg
A-5020
Austria

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

DW-7111-12570

Study information

Scientific title

Acronym

EADMP

Study hypothesis

The Austrian Disease Management Programme for Diabetes aims to improve metabolic control and cardiovascular risk profile in patients with diabetes mellitus type two. It involves structured care, patient guidance, patient reminders, physician reminders, physician education.

Hypothesis:
The Austrian Disease Management Programme for Diabetes improves metabolic control and cardiovascular risk profile in patients with diabetes mellitus type two.

Ethics approval

Approval received from the Ethics Commission of the Province of Salzburg, Austria on the 28th February 2007 (ref: 415-E779/2-2007).

Study design

Cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Diabetes mellitus type two

Intervention

The Austrian Disease Management Programme for Diabetes involves the following:

Structured care:
Physicians are encouraged to use standard documentation and a checklist of control examinations that are appropriate to current guidelines.

Patient guidance:
1. Regular doctors visits (at least every three months)
2. Patient education provided by a diabetes counsellor/nurse and/or physicians specifically trained in patient education in diabetes; four modules of 135 minutes each on the following topics:
2.1. General information about diabetes
2.2. Methods of metabolic control (glucose self-control)
2.3. Medication for diabetes
2.4. Nutrition/diet
2.5. Diabetic foot syndrome
2.6. Importance of physical activity
2.7. Cardiovascular risk factors
2.8. Micro- and macro-angiopathy
Given once at the beginning of the DMP and repeated at least once every three years.

Patient reminders:
Letter of information that patient should visit his doctor and discuss appropriate steps, administered by the Salzburg Public Health Insurance.

Physician reminders:
Letter of information that patient should be invited to visit and which steps should be taken, administered by the Salzburg Public Health Insurance.

Physician education:
10 hours of Continuous Medical Education (CME) provided by the Department of Diabetology of the Paracelsus University Hospital - Salzburger Landeskliniken and the Institute of General Practice, Family Medicine and Prevention at the beginning of DMP on current guidelines and management of diabetes mellitus type two; information about the DMP.

The DMP will be run for one year for the randomised trial, however continuation is planned.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The following will be assessed at baseline and after one year (i.e. at the end of the trial):
1. HbA1c
2. Number of days hospitalised
3. Percentage of physical and laboratory examinations according to current guidelines

Secondary outcome measures

The following will be assessed at baseline and after one year (i.e. at the end of the trial):
1. Cardiovascular risk profile
2. Weight reduction
3. Smoking cessation
4. Improved knowledge about diabetes
5. Improved quality of life (measured using the EuroQoL [EQ-5D] questionnaire)
6. Improved patient satisfaction

Overall trial start date

01/07/2007

Overall trial end date

31/10/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with diabetes mellitus type two (American Diabetes Association [ADA]/World Health Organisation [WHO] criteria)
2. Aged greater than 18 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1200

Participant exclusion criteria

1. Dementia
2. Psychiatric illness
3. Malignant tumour

Recruitment start date

01/07/2007

Recruitment end date

31/10/2008

Locations

Countries of recruitment

Austria

Trial participating centre

Strubergasse 21
Salzburg
A-5020
Austria

Sponsor information

Organisation

Salzburg Public Health Insurance (Salzburger Gebietskrankenkasse [SGKK]) (Austria)

Sponsor details

Fabergasse 19
Salzburg
A-5020
Austria
marlies.dicklberger@sgkk.at

Sponsor type

Industry

Website

http://esv.sgkk.at

Funders

Funder type

Industry

Funder name

Salzburg Public Health Insurance (Salzburger Gebietskrankenkasse [SGKK]) (Austria)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Investigator funding

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

1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/21054881

Publication citations

  1. Results

    Sönnichsen AC, Winkler H, Flamm M, Panisch S, Kowatsch P, Klima G, Fürthauer B, Weitgasser R, The effectiveness of the Austrian disease management programme for type 2 diabetes: a cluster-randomised controlled trial., BMC Fam Pract, 2010, 11, 86, doi: 10.1186/1471-2296-11-86.

Additional files

Editorial Notes