Monıtorıng Glucocortıcoıd Treatment In Patıents Followed In Rheumatology Clınıc

August 1, 2022 updated by: Melda Bahap, Hacettepe University

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

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • Ankara, Turkey, 06100
        • Recruiting
        • Hacettepe University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
RA, SLE, and vasculitis patients who have just started glucocorticoid treatment
RA, SLE and vasculitis patients receiving glucocorticoid treatment for the last 2 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in Glucocorticoid Toxicity Index (GTI) scores
Time Frame: 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.
Each patient will be followed up for a total of 6 months, at 3 and 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Investigators

  • Study Director: Omer Karadag, prof. doctor, Hacettepe University Faculty of Medicine, Department of Internal Medicine, Division of Rheumatology,

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Anticipated)

August 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

March 14, 2022

First Submitted That Met QC Criteria

March 14, 2022

First Posted (Actual)

March 23, 2022

Study Record Updates

Last Update Posted (Actual)

August 3, 2022

Last Update Submitted That Met QC Criteria

August 1, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KA- 21026

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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