Monıtorıng Glucocortıcoıd Treatment In Patıents Followed In Rheumatology Clınıc

NCT ID: NCT05292456

Last Updated: 2022-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-01

Study Completion Date

2022-12-31

Brief Summary

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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

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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.

Conditions

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Glucocorticoids Toxicity Rheumatoid Arthritis Vasculitis Systemic Lupus Erythematosus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Melda Bahap

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Omer Karadag, prof. doctor

Role: STUDY_DIRECTOR

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

Locations

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Hacettepe University

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Melda Bahap, master of science

Role: CONTACT

+905398979922

Emine Duran, md

Role: CONTACT

+905372103145

Facility Contacts

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Melda Bahap, master of science

Role: primary

05398979922

Other Identifiers

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KA- 21026

Identifier Type: -

Identifier Source: org_study_id

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