Monıtorıng Glucocortıcoıd Treatment In Patıents Followed In Rheumatology Clınıc

• Conditions: Rheumatoid Arthritis; Glucocorticoids Toxicity; Vasculitis; Systemic Lupus Erythematosus

• Registration Number: NCT05292456
• Lead Sponsor: Hacettepe University

Brief Summary

Hypothesis 1: A reduction in side effects is achieved with monitoring glucocorticoid treatment by using the Glucocorticoid Toxicity Index (GTI) in patients using glucocorticoids.

Hypothesis 2: Monitoring treatment by using GTI in patients using glucocorticoids causes a decrease in glucocorticoid toxicity and an increase in the quality of life of patients.

Hypothesis 3: With the involvement of the clinical pharmacist in the multidisciplinary team in patients using glucocorticoids, the drug-related problems of the patients are detected and prevented.

The aim of this study was to evaluate the glucocorticoid treatment of patients with RA, SLE and vasculitis treated with glucocorticoids prospectively by a multidisciplinary team with GTI. In addition, it was aimed to identify and prevent drug-related problems by reviewing all drugs used in these patients by the clinical pharmacist.

Detailed Description

In this study, the side effects of glucocorticoids used by patients will be evaluated using the Glucocorticoid Toxicity Index (GTI) index. This index includes areas for commonly recognized adverse events as a result of cumulative steroid exposure. It is weighted and measures both worsening and improvement. Scores range from -346 to 439 with cumulative worsening score relating to an increase in GC toxicity burden. "-" points indicate improvement, "+" points indicate worsening. The higher the patient's burden of glucocorticoid toxicity, the higher his score.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-02-01
• Study First Submitted: 2022-03-14
• Study First Submitted QC: 2022-03-14
• Study First Posted: 2022-03-23
• Status Verified: 2022-08
• Primary Completion: 2022-08
• Last Update Submitted: 2022-08-01
• Last Update Posted: 2022-08-03
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• 18 years and over
• Individuals who have received glucocorticoid treatment for RA, SLE or vasculitis in the last 2 years or at current admission.
• Patients approved by the physician to participate in the study
• Patients giving written consent

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Exclusion Criteria

• Younger than 18
• Patients with communication disabilities
• Patients involved in another clinical and/or drug trial

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
change in Glucocorticoid Toxicity Index (GTI) scores	Each patient will be followed up for a total of 6 months, at 3 and 6 months.	In this study, it is predicted that a change in GTI scores will be achieved during 3-month follow-up in patients with long-term and newly diagnosed RA, SLE and vasculitis. When the 6-month follow-up of each patient is completed, the study will be terminated.; In this study, the side effects of glucocorticoids used by patients will be evaluated using the Glucocorticoid Toxicity Index (GTI) index. This index includes areas for commonly recognized adverse events as a result of cumulative steroid exposure. It is weighted and measures both worsening and improvement. Scores range from -346 to 439 with cumulative worsening score relating to an increase in GC toxicity burden. "-" points indicate improvement, "+" points indicate worsening. The higher the patient's burden of glucocorticoid toxicity, the higher his score.

Trial Locations

Locations (1)

Hacettepe University; 🇹🇷 Ankara, Turkey