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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/21054881
Publication citations
-
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.