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Monıtorıng Glucocortıcoıd Treatment In Patıents Followed In Rheumatology Clınıc

Monıtorıng Glucocortıcoıd Treatment Using Glucocorticoid Toxicity Index (GTI) In Patıents Followed In Rheumatology Clınıc

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05292456
Enrollment
200
Registered
2022-03-23
Start date
2021-02-01
Completion date
2022-12-31
Last updated
2022-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glucocorticoids Toxicity, Rheumatoid Arthritis, Systemic Lupus Erythematosus, Vasculitis

Keywords

glucocorticoid toxicity index, Drug-Related Problem, Glucocorticoid, Rheumatoid Arthritis, Vasculitis, Clinical Pharmacist

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.

Interventions

None listed

Sponsors

Hacettepe University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
change in Glucocorticoid Toxicity Index (GTI) scoresEach 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.

Countries

Turkey (Türkiye)

Contacts

Primary ContactMelda Bahap, master of science
melda_610@hotmail.com+905398979922
Backup ContactEmine Duran, md
docemineduran@gmail.com+905372103145

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026