Effectivity of the Austrian Disease Management Programme for diabetes regarding metabolic control and risk profile

ISRCTN	ISRCTN27414162
DOI	https://doi.org/10.1186/ISRCTN27414162
Protocol serial number	DW-7111-12570
Sponsor	Salzburg Public Health Insurance (Salzburger Gebietskrankenkasse [SGKK]) (Austria)
Funders	Salzburg Public Health Insurance (Salzburger Gebietskrankenkasse [SGKK]) (Austria), Investigator funding

Submission date: 06/06/2007
Registration date: 12/07/2007
Last edited: 23/02/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Andreas Sönnichsen
Scientific

Strubergasse 21
Salzburg
A-5020
Austria

Study information

Primary study design	Interventional
Study design	Cluster randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study acronym	EADMP
Study objectives	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(s)	Approval received from the Ethics Commission of the Province of Salzburg, Austria on the 28th February 2007 (ref: 415-E779/2-2007).
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	31/10/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	1200
Key inclusion criteria	1. Patients with diabetes mellitus type two (American Diabetes Association [ADA]/World Health Organisation [WHO] criteria) 2. Aged greater than 18 years
Key exclusion criteria	1. Dementia 2. Psychiatric illness 3. Malignant tumour
Date of first enrolment	01/07/2007
Date of final enrolment	31/10/2008

Locations

Countries of recruitment

Austria

Study participating centre

Strubergasse 21

Salzburg
A-5020
Austria

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	05/11/2010		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes