Clinical trial NCT05292456: Monıtorıng Glucocortıcoıd Treatment In Patıents Followed In Rheumatology Clınıc
Official title: Monıtorıng Glucocortıcoıd Treatment Using Glucocorticoid Toxicity Index (GTI) In Patıents Followed In Rheumatology Clınıc
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glucocorticoids Toxicity
Rheumatoid Arthritis
Vasculitis
Systemic Lupus Erythematosus
Keywords: glucocorticoid toxicity index
Drug-Related Problem
Glucocorticoid
Rheumatoid Arthritis
Vasculitis
Clinical Pharmacist
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2022-03-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of RA, SLE or vasculitis followed in the Hacettepe University Hospitals Rheumatology Outpatient Clinic and receiving glucocortioid therapy will be included in the study.

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.

Eligibility criteria: 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

Exclusion Criteria:

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

Primary outcomes:
measure: change in Glucocorticoid Toxicity Index (GTI) scores
timeFrame: Each patient will be followed up for a total of 6 months, at 3 and 6 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe University Faculty of Medicine, Department of Internal Medicine, Division of Rheumatology,
name: Omer Karadag, prof. doctor
role: STUDY_DIRECTOR
References: