Statin Compliance of Patients With Non-insulin-dependent Diabetes

NCT04007133 | Terminated

• 1 other identifier: RC-P0064
• Study Type: observational
• Target: 119
• Locations: 1 country
• Sites: 1

Brief Summary

The diabetic population has an increased cardiovascular risk compared to the general population. Hydroxymethylglutaryl-CoA reductase (HMG-CoA reductase) inhibitors, or "statins", are considered as the standard treatment for hypercholesterolemia. Many patients with non-insulin-dependent diabetes are prescribed with statins, both for primary prevention, before the first cardiovascular event, and as secondary prevention, to avoid recurrence. However, compliance to these drugs may be difficult due to polypharmacy, side effects (myalgia) or tiredness. The purpose of this study is to determine the compliance of diabetic patients with statins searching for important factors which could favor adherence.

Conditions

Non-insulin-dependent Diabetes

Keywords

Non-insulin-dependent diabetes; Statins; Compliance

Outcome Measures

Primary Outcomes (1)

• Compliance rate with statin measured by the Girerd test

  This is a simple and quick questionnaire, composed of 6 questions with a binary yes/no answer. It allows to assess the degree of compliance with the prescribed treatment and thus to better identify the constraints related to the treatment. The score varies from 0 to 6 depending on the presence of "yes". 0 "yes": Good compliance, more than 3 "yes": non compliance.

  Day 0

Secondary Outcomes (2)

• Compliance rate with statin according to the type of prevention

  Day 0

• Compliance rate with statin according to risk factors

  Day 0

Study Arms (1)

Diabetic patients

Patients with non-insulin-dependent diabetes, taking statins for at least 1 month

Other: Girerd test

Interventions

Girerd test OTHER

This is a simple and quick questionnaire, composed of 6 questions with a binary yes/no answer. It allows to assess the degree of compliance with the prescribed treatment to better identify the constraints related to the treatment.

Diabetic patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with non-insulin-dependent diabetes, taking statins for at least 1 month

You may qualify if:

• Major patients
• With non-insulin-dependent diabetes, taking statins for at least 1 month (to assess compliance)
• Hospitalized in the Diabetology Day Hospital of the Saint Philibert Hospital
• In capacity to answer the Girerd test
• Patient who has been informed and not opposed to the study

You may not qualify if:

• Patient's refusal to participate in the study
• Patient under guardianship or curatorship

Sponsors & Collaborators

• Lille Catholic University: lead
• University Hospital, Lille: collaborator

Study Sites (1)

Lille Catholic Hospitals

Lomme, Nord, 59462, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Patient Compliance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; 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 Design

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

Study Record Dates

• First Submitted: July 1, 2019
• First Posted: July 5, 2019
• Study Start: January 31, 2018
• Primary Completion: July 12, 2018
• Study Completion: July 12, 2018
• Last Updated: July 17, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)