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Educational Intervention Targeting Statin Therapy and Compliance in Diabetic Patients

Can Educational Intervention Targeting Statin Therapy Improve Compliance in Diabetic Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04499846
Acronym
STADIA
Enrollment
96
Registered
2020-08-05
Start date
2020-06-11
Completion date
2021-05-07
Last updated
2021-10-13

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

Conditions

Type II Diabetes

Keywords

Diabetes, Compliance, Statin, Education

Brief summary

The objective of the study is to measure changes in compliance to statin therapy in patients with type 2 diabetes after an educational intervention. This intervention is part of the therapeutic education of the diabetic patient, carried out throughout the follow-up of his/her diabetes.

Interventions

OTHERTherapeutic education

Patients will follow a therapeutic education in order to inform them about the mechanism of action of statins. After this intervention a questionnaire will use to measure compliance.

Sponsors

Lille Catholic University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 18 years old or more * Type 2 diabetes * Following treatment with statins * Hospitalization in the diabetes day hospitals of the Saint Philibert or Saint Vincent Hospitals (Lille, France). * Ability to answer the Girerd test in both interviews (in the individual interview and by phone) * Patient informed to participate in the study * Signed patient's consent.

Exclusion criteria

* Patients under guardianship

Design outcomes

Primary

MeasureTime frameDescription
Compliance rate to the statin treatment3 monthsCompliance is estimated with the compliance evaluation Test of Girerd based on a score from 0 to 6. Six questions are asked to the patient. For the interpretation of the test: Total YES = 0, Score = 0: Good compliance Total YES = 1 or 2, Score = 1 or 2: Minimal compliance Total YES ≥ 3, Score ≥ 3: Poor compliance Lack of completion of the questionnaire is considered as poor compliance.

Secondary

MeasureTime frameDescription
Compliance rate to the statin treatment according to schedule of drug intake3 monthsCompliance is estimated with the compliance evaluation Test of Girerd based on a score from 0 to 6. Six questions are asked to the patient. For the interpretation of the test: Total YES = 0, Score = 0: Good compliance Total YES = 1 or 2, Score = 1 or 2: Minimal compliance Total YES ≥ 3, Score ≥ 3: Poor compliance Lack of completion of the questionnaire is considered as poor compliance.
Compliance rate to the statin treatment according to treatment duration.3 monthsCompliance is estimated with the compliance evaluation Test of Girerd based on a score from 0 to 6. Six questions are asked to the patient. For the interpretation of the test: Total YES = 0, Score = 0: Good compliance Total YES = 1 or 2, Score = 1 or 2: Minimal compliance Total YES ≥ 3, Score ≥ 3: Poor compliance Lack of completion of the questionnaire is considered as poor compliance.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026