Educational Intervention Targeting Statin Therapy and Compliance in Diabetic Patients

Type II Diabetes Clinical Trial

— STADIA  

Official title:

Can Educational Intervention Targeting Statin Therapy Improve Compliance in Diabetic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04499846
• Other study ID #: RC-P0096
• Secondary ID: 2020-A00402-37
• Status: Completed
• Start date: June 11, 2020
• Est. completion date: May 7, 2021

Study information

• Verified date: October 2021
• Source: Lille Catholic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: May 7, 2021
• Est. primary completion date: May 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type II Diabetes

Intervention

Other:
• Therapeutic 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.

Locations

Country	Name	City	State
France	Hôpital Saint-philibert	Lomme	Nord Pas De Calais

Sponsors (1)

Lead Sponsor	Collaborator
Lille Catholic University

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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".	3 months
Secondary	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".	3 months
Secondary	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".	3 months