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Educational Intervention Targeting Statin Therapy and Compliance in Diabetic Patients (STADIA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04499846
Recruitment Status : Recruiting
First Posted : August 5, 2020
Last Update Posted : August 5, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Type II Diabetes Other: Therapeutic education

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Study Type : Observational
Estimated 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 : June 11, 2020
Estimated Primary Completion Date : March 11, 2021
Estimated Study Completion Date : September 9, 2021

Resource links provided by the National Library of Medicine


Group/Cohort 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.




Primary Outcome Measures :
  1. Compliance rate to the statin treatment [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 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".




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Diabetic patients hospitalized in the diabetes day hospitals of the Saint Philibert or Saint-Vincent hospitals (Lille, France)
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04499846


Contacts
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Contact: Amélie Lansiaux, MD, PhD +33320225269 lansiaux.amelie@ghicl.net
Contact: Marine DESEUR +33320225269 deseur.marine@ghicl.net

Locations
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France
Hôpital Saint-philibert Recruiting
Lomme, France
Contact: Marine Deseur    03.20.22.52.69    deseur.marine@ghicl.net   
Sponsors and Collaborators
Lille Catholic University
Investigators
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Principal Investigator: François Delecourt, MD GHICL
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Responsible Party: Lille Catholic University
ClinicalTrials.gov Identifier: NCT04499846    
Other Study ID Numbers: RC-P0096
2020-A00402-37 ( Other Identifier: IDRCB )
First Posted: August 5, 2020    Key Record Dates
Last Update Posted: August 5, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases