Educational Intervention Targeting Statin Therapy and Compliance in Diabetic Patients

NCT04499846 | Completed

• 2 other identifiers: RC-P00962020-A00402-37
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Type II Diabetes

Keywords

Diabetes; Compliance; Statin; Education

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  3 months

• Compliance rate to the statin treatment according to treatment duration.

  3 months

Study Arms (1)

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

Interventions

Therapeutic education OTHER

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.

Diabetic patients following education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Diabetic patients hospitalized in the diabetes day hospitals of the Saint Philibert or Saint-Vincent hospitals (Lille, France)

You may qualify if:

• 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.

You may not qualify if:

• Patients under guardianship

Sponsors & Collaborators

• Lille Catholic University: lead

Study Sites (1)

Hôpital Saint-philibert

Lomme, Hauts-de-France, 59462, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Patient Compliance

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• François Delecourt, MD

  GHICL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2020
• First Posted: August 5, 2020
• Study Start: June 11, 2020
• Primary Completion: May 7, 2021
• Study Completion: May 7, 2021
• Last Updated: October 13, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)