Effectivity of the Austrian Disease Management Programme for diabetes regarding metabolic control and risk profile
| ISRCTN | ISRCTN27414162 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27414162 |
| Secondary identifying numbers | DW-7111-12570 |
- 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
Scientific
Strubergasse 21
Salzburg
A-5020
Austria
Study information
| Study design | Cluster randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/07/2007 |
| Completion date | 31/10/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
A-5020
Austria
Sponsor information
Salzburg Public Health Insurance (Salzburger Gebietskrankenkasse [SGKK]) (Austria)
Industry
Industry
Fabergasse 19
Salzburg
A-5020
Austria
| marlies.dicklberger@sgkk.at | |
| Website | http://esv.sgkk.at |
Funders
Funder type
Industry
Salzburg Public Health Insurance (Salzburger Gebietskrankenkasse [SGKK]) (Austria)
No information available
Investigator funding
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
