Educational Intervention Targeting Statin Therapy and Compliance in Diabetic Patients

Completed

• Conditions: Type II Diabetes
• Interventions: Other: Therapeutic education

• Registration Number: NCT04499846
• Lead Sponsor: Lille Catholic University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-11
• Study First Submitted: 2020-07-28
• Study First Submitted QC: 2020-08-04
• Study First Posted: 2020-08-05
• Primary Completion: 2021-05-07
• Study Completion: 2021-05-07
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-12
• Last Update Posted: 2021-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diabetic patients following education	Therapeutic education	Patients will followed an educational intervention about physiopathology of diabetes and mechanisms of action of statins. A questionnaire will allow to measure compliance to the treatment.

Primary Outcome Measures

Name	Time	Method
Compliance rate to the statin treatment	3 months	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".

Secondary Outcome Measures

Name	Time	Method
Compliance rate to the statin treatment according to schedule of drug intake	3 months	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".
Compliance rate to the statin treatment according to treatment duration.	3 months	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".

Trial Locations

Locations (1)

Hôpital Saint-philibert; 🇫🇷 Lomme, Nord Pas De Calais, France