Monıtorıng Glucocortıcoıd Treatment In Patıents Followed In Rheumatology Clınıc

NCT05292456 | Unknown

• 1 other identifier: KA- 21026
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Glucocorticoids Toxicity; Rheumatoid Arthritis; Vasculitis; Systemic Lupus Erythematosus

Keywords

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

Outcome Measures

Primary Outcomes (1)

• change in Glucocorticoid Toxicity Index (GTI) scores

  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.

  Each patient will be followed up for a total of 6 months, at 3 and 6 months.

Study Arms (2)

RA, SLE, and vasculitis patients who have just started glucocorticoid treatment

RA, SLE and vasculitis patients receiving glucocorticoid treatment for the last 2 years

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid; Vasculitis; Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Omer Karadag, prof. doctor

  Hacettepe University Faculty of Medicine, Department of Internal Medicine, Division of Rheumatology,

  STUDY DIRECTOR

Central Study Contacts

Melda Bahap, master of science

CONTACT

+905398979922; melda_610@hotmail.com

Emine Duran, md

CONTACT

+905372103145; docemineduran@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: March 23, 2022
• Study Start: February 1, 2021
• Primary Completion: August 1, 2022
• Study Completion: December 1, 2022
• Last Updated: August 3, 2022

Record last verified: 2022-08

Locations

TU (1)