- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03324750
Long-term Corticosteroid Use and Lifestyle Advices: A Qualitative Analysis of the Difficulties Encountered by Patients
Introduction: Nearly 1% of the population is currently treated with long-term corticosteroid therapy. When corticosteroids are introduced, patient information concerning the adverse effects and the modalities of prevention by the lifestyle changes is usually proposed. However, studies have shown an imperfect acquisition of this information about treatment and prevention of adverse effects, as well as a difficult implementation on diet and physical activity advices. In this study, the investigators aimed to evaluate the difficulties encountered by patients with dietary advice in the context of long-term corticosteroids use in order to optimize care, drug adherence and the quality of life of patients.
Methods: the investigators will recruite adult patients from general medicine and rheumatology practice and treated by long-term corticosteroids (≥ 3 months, ≥ 5mg/day). the investigators will perform a qualitative analysis in a semi-directed interview.
Study Overview
Status
Conditions
Detailed Description
Prospective Qualitative Study Carried out among patients followed in rheumatology and in general medical practice.
For each voluntary patient, a semi-directed interview was carried out in a consultation room after obtaining his agreement.
The same investigator used a single guide and conducted all the interviews based on open-ended questions.
At the end of the interviews, the entire recorded audio data was converted in written form before being analysed thematically.
Data were analysed using a Fisher's exact test for categorical variables (presented as frequencies and percentages), and using a non-parametric Mann-Whitney test for continuous variables (presented as the median and interquartile range, IQR).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Montpellier, France, 34000
- CHU Lapeyronie
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- adult patients taking corticosteroids at an average dose ≥ 5 mg/day of equivalent prednisone over a period ≥ 3 months.
Exclusion Criteria:
- major memory impairment or language barrier.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the difficulties encountered by patient in relation to the health and dietary advice given by physicians in the context of long term corticodteroid use
Time Frame: 1 day
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To determine the difficulties encountered by patient in relation to the health and dietary advice given by physicians in the context of long term corticodteroid use
|
1 day
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- RECHMPL17_0330
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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