ELSID - Evaluation of a Large Scale Implementation of Disease Management Programmes for patients with type 2 diabetes
| ISRCTN | ISRCTN08471887 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN08471887 |
| Protocol serial number | N/A |
| Sponsor | AOK-Bundesverband (Germany) |
| Funder | AOK-Bundesverband |
- Submission date
- 22/06/2005
- Registration date
- 20/07/2005
- Last edited
- 02/10/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Joachim Szecsenyi
Scientific
Scientific
Vossstrasse 2
Heidelberg
69115
Germany
| Phone | +49 6221 56 4745 |
|---|---|
| joachim.szecsenyi@med.uni-heidelberg.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | ELSID - Evaluation of a Large Scale Implementation of Disease Management Programmes for patients with type 2 diabete: a randomised controlled trial |
| Study acronym | ELSID |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) | HbA1c and blood pressure. |
| Key secondary outcome measure(s) | Prescriptions, hospitalizations, referrals, severe complications, SCORE risk chart. |
| Completion date | 31/07/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 4000 |
| Key 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 |
| Key exclusion criteria | Control group: Practices or Patients participating in any Disease Management Programmes |
| Date of first enrolment | 01/08/2005 |
| Date of final enrolment | 31/07/2008 |
Locations
Countries of recruitment
- Germany
Study participating centre
Vossstrasse 2
Heidelberg
69115
Germany
69115
Germany
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? |
|---|---|---|---|---|---|
| Protocol article | protocol | 04/10/2005 | Yes | No |
Editorial Notes
02/10/2017: internal review.
