NCT04499846 - Educational Intervention Targeting Statin Therapy and Compliance in Diabetic Patients | Crick

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

96

Conditions

Type II Diabetes

Interventions

Therapeutic educationOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hôpital Saint-philibert

Lomme, Hauts-de-France, France

Outcomes

Primary Outcomes

Compliance rate to the statin treatment

Compliance 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".

Time frame: 3 months

Secondary Outcomes

Compliance rate to the statin treatment according to schedule of drug intake

Compliance 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".

Time frame: 3 months

Compliance rate to the statin treatment according to treatment duration.

Compliance 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".

Time frame: 3 months