Improvement of primary health care for patients with diabetes
| ISRCTN | ISRCTN70713571 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70713571 |
| Secondary identifying numbers | 01GX1041 |
- Submission date
- 10/03/2011
- Registration date
- 17/06/2011
- Last edited
- 15/05/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
The aim of this study is to improve primary healthcare for patients with poorly regulated type 2 diabetes mellitus by improving communication between the patient and the general practitioner (GP). We want to enable participating GPs to identify the needs of patients suffering from poorly regulated type 2 diabetes mellitus, and to foster shared decision-making.
Who can participate?
We will recruit about 60 GPs in three study centres (Rostock, Düsseldorf and Witten-Herdecke), who will each include about 13 randomly chosen type 2 diabetes mellitus patients (780 in total).
What does the study involve?
Participating GPs will be randomly allocated into either the intervention or the control group. Patient data, such as HbA1c level and prescribed drugs, will be collected at five different points in time during the study period of 36 months. Patients whose GPs are assigned into the control group will be treated as usual. The GPs assigned to the intervention group will have a conversation with a GP peer, which aims at increasing their motivation to improve poorly regulated blood sugar levels of patients suffering from type 2 diabetes. They will also be trained and equipped with a computer-based communication tool called arriba, which is especially adapted to patients suffering from diabetes. The effect of the intervention will be measured by the changes in the patient's blood sugar level, by their level of participation in the process of shared decision-making, and their quality of life.
What are the possible benefits and risks of participating?
Patients may benefit from improved management of their type 2 diabetes. There are no risks of participating.
Where is the study run from?
We will recruit about 60 GPs in three study centres (Rostock, Düsseldorf and Witten-Herdecke). The study is run from the University of Rostock (Germany).
When is the study starting and how long is it expected to run for?
The study started in March 2011 and will run until August 2015.
Who is funding the study?
German Federal Ministry of Education and Research (BMBF) (Germany).
Who is the main contact?
Prof Attila Altiner
ifa.sekretariat@med.uni-rostock.de
Contact information
Scientific
University of Rostock
Medizinische Fakultät
Institut für Allgemeinmedizin
POB 100888
Rostock
18055
Germany
| Phone | +49 (0)38 1494 2481 |
|---|---|
| ifa.sekretariat@med.uni-rostock.de |
Study information
| Study design | Cluster-randomised controlled trial with educative intervention |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | http://allgemeinmedizin.med.uni-rostock.de/uploads/media/Informationsblatt-Pat_DEBATE_20110415.pdf (In German) |
| Scientific title | Improvement of primary health care of patients with poorly regulated diabetes mellitus type 2 using shared decision-making |
| Study acronym | DEBATE |
| Study objectives | Changing the communication behaviour of general practitioners to foster shared decision-making (with their patients) utilising developed top decision-aid-diabetes (decision-aid arriba-diabetes) improves health outcomes of patients with poorly regulated diabetes cared for in primary health. HbA1c serves as primary outcome measure. On 19/05/2014 the overall trial end date was changed from 28/02/2014 to 31/08/2015. On 30/06/2015 the target number of participants was changed from '60 GPs each with 13 patients; a total of 780 patients' to '108 GPs, each recruiting a consecutive sample of up to 13 patients (on average 7.8 patients per practice), a total of 843 patients'. |
| Ethics approval(s) | Ethics Committee of the Medical Faculty, University of Rostock, 25/05/2011 |
| Health condition(s) or problem(s) studied | Diabetes mellitus type 2 |
| Intervention | 1. Cluster-randomised multi-centre controlled trial with an educative intervention (peer-visit and decision-aid arriba-diabetes) 2. Clusters are composed by GPs and patients 3. The GPs in the intervention group will receive an educational peer-visit 4. The peer himself will be a specially trained GP 5. The control group will receive care as usual 6. The study will be performed under real practice conditions |
| Intervention type | Behavioural |
| Primary outcome measure | Current primary outcome as of 10/01/2012 1. Change of HbA1c at 6, 12, 18, 24 months compared to HbA1c at baseline 2. HbA1c will be measured as routine examinaton, as the case may be within the scope of the German Disease Management Program performed at GP's medical practice Previous primary outcome 1. Change of HbA1c at 6, 12, 18, 24 months compared to HbA1c at baseline 2. HbA1c will be measured as routine examination within the scope of the German Disease Management Program performed at GP's medical practice |
| Secondary outcome measures | Current secondary outcome as of 10/01/2012 1. Patient's evaluation of patient-centeredness and life quality (PACIC-D, PEF-FB-9, BÄK-questionnaire, EQ-5D, PAID) 2. Cardiovascular risk prognosis 3. Pharmacotherapy Previous secondary outcome 1. Patient's evaluation of patient-centeredness and life quality (PACIC-D, PEF-FB-9, SF-36) 2. Cardiovascular risk prognosis 3. Pharmacotherapy |
| Overall study start date | 01/03/2011 |
| Completion date | 31/08/2015 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 108 GPs, each recruiting a consecutive sample of up to 13 patients (on average 7.8 patients per practice), a total of 843 patients |
| Total final enrolment | 833 |
| Key inclusion criteria | Current inclusion criteria as of 30/06/2015: Patients: 1. Diabetes mellitus type 2 2. HbA1c level of 8.0 or above at the time of recruitment 3. Ability to informed consent 4. Fluency in the German language GPs: 1. General practitioner or internist, working as GP or practitioner with KV admission (Association of Statutory Health Insurance Physicians) Previous inclusion criteria from 10/01/2012 to 30/06/2015: Patients: 1. Diabetes mellitus type 2 2. HbA1c level of 8.1 or above at the time of recruitment 3. Ability to informed consent 4. Fluency in the German language GPs: 1. General practitioner or internist, working as GP or practitioner with KV admission (Association of Statutory Health Insurance Physicians) Original inclusion criteria until 10/01/2012: Patients: 1. Diabetes mellitus type 2 2. HbA1c level of 8.5 or above at the time of recruitment 3. Ability to informed consent 4. Fluency in the German language GPs: 1. General practitioner or internist, working as GP or practitioner with KV admission (Association of Statutory Health Insurance Physicians) 2. Participation on the Disease Management Program diabetes mellitus type 2 |
| Key exclusion criteria | 1. Severe comorbidity 2. Life expectancy of less than 18 months |
| Date of first enrolment | 01/03/2011 |
| Date of final enrolment | 31/08/2015 |
Locations
Countries of recruitment
- Germany
Study participating centres
Doberaner Strasse 142
P.O. Box 108880
Rostock
18057
Germany
Moorenstraße 5
Düsseldorf
40225
Germany
Universität Witten/Herdecke
Alfred-Herrhausen-Straße 50
Witten
58448
Germany
Sponsor information
Government
c/o Projektträger im DLR
Heinrich-Konen-Straße 1
Bonn
53227
Germany
| Phone | +49 (0)22 8382 1152 |
|---|---|
| Eva.Becher@dlr.de | |
| Website | http://dlr.de |
"ROR" |
https://ror.org/04pz7b180 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Federal Ministry of Education and Research, BMBF
- Location
- Germany
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 | 25/06/2019 | 27/06/2019 | Yes | No |
| Results article | 15/05/2021 | 17/05/2021 | Yes | No | |
| Results article | Secondary analysis | 13/05/2023 | 15/05/2023 | Yes | No |
Editorial Notes
15/05/2023: Publication reference added.
17/05/2021: Publication reference added.
27/06/2019: Publication reference and total final enrolment added.
