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Improvement of primary health care for patients with diabetes

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN70713571
Enrollment
843
Registered
2011-06-17
Start date
2011-03-01
Completion date
Unknown
Last updated
2023-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes mellitus type 2 Nutritional, Metabolic, Endocrine Non-insulin-dependent diabetes mellitus

Interventions

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 interven

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 22, 2026