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Diabetes Project Leuven, Belgium.

A clustered randomized trial in diabetes care to improve adherence to guidelines and to reduce the rate of clinical inertia in primary care physicians

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON21652
Enrollment
120
Registered
2008-07-07
Start date
2005-01-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Diabetes mellitus type 2, adherence to guidelines, clinical inertia, primary care

Interventions

Type of interventions: Two separate groups are randomly defined. The first group receives an advanced quality improvement program (AQIP-program) whereas a second group receives a usual quality impro

Sponsors

National Institute for Health and Disability Insurance, Belgium
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All 379 primary care physicians (PCP’s) that actively execute their profession in the project region were invited to participate. These PCP’s work in a semi-rural setting with 357.000 inhabitants in Belgium and predominantly serve Caucasian patients with diabetes mellitus type 2. Primary care physicians provide care for approximately 80% of patients with type 2 diabetes, and are often the sole providers of care. The only inclusion criterion for the providers is the agreement to bring in all their known patients with type 2 diabetes mellitus. In this way selection bias is prevented. In addition, PCP’s will be asked to screen more systematically for new type 2 diabetes mellitus patients during 7 months after the start of the registration period. Diabetes is defined in accordance to the 2003 ADA criteria with PCP’s to take the final decision about the diagnosis of type 2 diabetes.

Exclusion criteria

Exclusion criteria: Type 1 diabetes mellitus patients. Patients not capable to provide informed consent.

Design outcomes

Primary

MeasureTime frame
The primary endpoints of the study are the proportion of patients reaching the ADA-targets for three bio-clinical outcomes: 1. HbA1c < 7% 2. SBD </ 130 mm Hg 3. LDL-C < 100mg/dl.

Secondary

MeasureTime frame
Secondary endpoints are individual improvements of 12 validated parameters, i.e. - HbA1c - LDLC - HDL-C - Total Cholesterol - SBP - Diastolic Blood Pressure (DBP) - Weight - Physical exercise - Healthy diet - Smoking status - Statin - Anti-platelet therapy.

Contacts

Public ContactLiesbeth Borgermans

Catholic University Leuven Department of General Practice

liesbeth.borgermans@med.kuleuven.be+32 473 99.10.90

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)