STADIA: Educational Intervention Targeting Statin Therapy and Compliance in Diabetic Patients

• Sponsor: Lille Catholic University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04499846
• Collaborator: (none)
• Enrollment: 96
• Location: 1
• Actual Duration (Months): 10.8
• Patients Per Site Per Month: 8.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type II Diabetes	Other: Therapeutic education

Study Design

• Study Type: Observational
• Actual Enrollment: 96 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Can Educational Intervention Targeting Statin Therapy Improve Compliance in Diabetic Patients
• Actual Study Start Date: Jun 11, 2020
• Actual Primary Completion Date: May 7, 2021
• Actual Study Completion Date: May 7, 2021

Arms and Interventions

Arm	Intervention/Treatment
Diabetic patients following 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.	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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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".

2. 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".

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Saint-philibert	Lomme	Nord Pas De Calais	France	59462

Sponsors and Collaborators

• Lille Catholic University

Investigators

• Principal Investigator: François Delecourt, MD, GHICL

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lille Catholic University
• ClinicalTrials.gov Identifier: NCT04499846
• Other Study ID Numbers: RC-P0096; 2020-A00402-37
• First Posted: Aug 5, 2020
• Last Update Posted: Oct 13, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Lille Catholic University: Diabetes; Compliance; Statin; Education
• Additional relevant MeSH terms: Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Oct 13, 2021