To test the feasibility of the set-up and logistics of the EUCCLID study.1. To assess quality indicators of clinical DM2 care2. To perform questionnaires on quality of life and psychological well-being in DM2 patients in various European countries3…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
A EUCCLID-CP: quality indicators of clinical diabetes care
B EUCCLID-PP: quality of life (EuroQol EQ-5D) and well-being (WHO-5)
C EUCCLID-GPP: primary care physician*s perception of the barriers to delivery
of effective diabetescare in general practice. All participating primary care
physicians will be asked to complete a questionnaire on barriers (Barriers to
Diabetes Care Tool) towards the delivery of effective primary diabetes care.
Secondary outcome
Not applicable
Background summary
Diabetes is one of the commonest chronic diseases managed in primary care.
Despite diabetes being a common condition, there is lack of representative
epidemiological data relating to its management, complications and long-term
follow-up. There are only a few studies that have investigated international
(European) differences. The EUCCLID study is a large European study comparing
the quality of DM2 care, as experienced by patients and GPs, and the prevalence
of complications of DM2 in 12 European countries.
Study objective
To test the feasibility of the set-up and logistics of the EUCCLID study.
1. To assess quality indicators of clinical DM2 care
2. To perform questionnaires on quality of life and psychological well-being in
DM2 patients in various European countries
3. To test a questionnaire on primary care physicians' perception of the
barriers to delivery of effective diabetes care in general practice.
Study design
Cross-sectional survey in 12 European countries comprising three parallel
studies:
A EUCCLID-CP: a study on actual clinical practice (CP)
B EUCCLID-PP: a study on patient*s perspective (PP)
C EUCCLID-GPP: a study on general practitioner*s perspective (GPP)
As such a study in so many countries is a huge undertaking, the EUCCLID Pilot
study will test the feasibility of the set-up and logistics. The protocol,
questionnaires and logistic processes of the EUCCLID study will be refined
based on the results of this pilot study.
Study burden and risks
The burden and risks associated with the study are minimal. It will consist of
one visit (30-40 minutes) and one venapuncture. The only risk is the possible
occurrence of a small bruise at the site of venapuncture.
K. Adenaerstr 33a
63225 Langen
Duitsland
K. Adenaerstr 33a
63225 Langen
Duitsland
Listed location countries
Age
Inclusion criteria
Patients will be included if they are known with type 2 diabetes, because of
• a diagnosis according to WHO-criteria, or
• according to a former clinical diagnosis resulting in the prescription of oral hypoglycaemic agents (OHAs) for at least 6 months with or without insulin, or
• according to a former clinical diagnosis resulting in a dietary advice (Note: diagnosis of DM2 should be 100% sure; if GP is in doubt patient should not be included!), or
• when starting insulin mono-therapy above age 35 (at least 1 year insulin use)
AND
• if they are mainly under GP care for treatment of their diabetes (to be decided by the GP).
.
Exclusion criteria
• Type 1 diabetes mellitus
• Diabetes of pregnancy
• Serious mental illness (such as Psychotic illness or dementia)
• Any other reason why a questionnaire in national language cannot be completed (such as language barrier)
• Unable to give written informed consent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL17773.041.07 |