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OpenTrials
Completed

NCT Number: 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Lapeyronie

Montpellier, 34000, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  1. 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

    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

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Oct 30, 2017
Registry last updated
Jul 19, 2018

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.