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NCT Number: NCT04499846

Educational Intervention Targeting Statin Therapy and Compliance in Diabetic Patients

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.

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Key information

Conditions

Type II Diabetes Behavior Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Health Behavior Metabolic Diseases Nutritional and Metabolic Diseases Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Saint-philibert

Lomme, Hauts-de-France, 59462, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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".

Sponsors and collaborators

Lead sponsor

Lille Catholic University

Other

Registry information

Official study title

Can Educational Intervention Targeting Statin Therapy Improve Compliance in Diabetic Patients

Acronym: STADIA

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 5, 2020
Registry last updated
Oct 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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