Condition category
Nutritional, Metabolic, Endocrine
Date applied
10/03/2011
Date assigned
17/06/2011
Last edited
30/06/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Attila Altiner

ORCID ID

Contact details

University of Rostock
Medizinische Fakultät
Institut für Allgemeinmedizin
POB 100888
Rostock
18055
Germany
+49 (0)38 1494 2481
ifa.sekretariat@med.uni-rostock.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

01GX1041

Study information

Scientific title

Improvement of primary health care of patients with poorly regulated diabetes mellitus type 2 using shared decision-making

Acronym

DEBATE

Study hypothesis

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

Ethics Committee of the Medical Faculty, University of Rostock, 25/05/2011

Study design

Cluster-randomised controlled trial with educative intervention

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

http://allgemeinmedizin.med.uni-rostock.de/uploads/media/Informationsblatt-Pat_DEBATE_20110415.pdf (In German)

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/03/2011

Overall trial end date

31/08/2015

Reason abandoned

Eligibility

Participant 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

Participant type

Mixed

Age group

Adult

Gender

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

Participant exclusion criteria

1. Severe comorbidity
2. Life expectancy of less than 18 months

Recruitment start date

01/03/2011

Recruitment end date

31/08/2015

Locations

Countries of recruitment

Germany

Trial participating centre

The Institute of General Practice
University Medical Center Rostock Doberaner Strasse 142 P.O. Box 108880
Rostock
18057
Germany

Trial participating centre

The Institute of General Practice
Universitätsklinikum der Heinrich-Heine Universität Düsseldorf Moorenstraße 5
Düsseldorf
40225
Germany

Trial participating centre

The Institute of General Practice and Family Practice
Fakultät für Gesundheit Universität Witten/Herdecke Alfred-Herrhausen-Straße 50
Witten
58448
Germany

Sponsor information

Organisation

German Federal Ministry of Education and Research (BMBF) (Germany)

Sponsor details

c/o Projektträger im DLR
Heinrich-Konen-Straße 1
Bonn
53227
Germany
+49 (0)22 8382 1152
Eva.Becher@dlr.de

Sponsor type

Government

Website

http://dlr.de

Funders

Funder type

Government

Funder name

Bundesministerium für Bildung und Forschung

Alternative name(s)

Federal Ministry of Education and Research, BMBF

Funding Body Type

government organisation

Funding Body Subtype

federal

Location

Germany

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes