- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07436494
Coronavirus Anxiety in Patients Using Biologic vs Conventional DMARDs
Comparison of Coronavirus-Related Anxiety Levels in Patients Using Biologic and Conventional Disease-Modifying Antirheumatic Drugs
The COVID-19 pandemic has caused significant psychological distress among patients with chronic diseases. Individuals receiving immunosuppressive therapies may experience increased anxiety due to perceived vulnerability to infection. This observational study aims to compare coronavirus-related anxiety levels in patients using biologic disease-modifying antirheumatic drugs (bDMARDs) and those using conventional disease-modifying antirheumatic drugs (cDMARDs).
Adult patients followed at the rheumatology outpatient clinic were contacted by telephone. After verbal consent was obtained, participants completed a patient information form and the Coronavirus Anxiety Scale. Anxiety levels and pandemic-related experiences were compared between treatment groups.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This observational cohort study was conducted at the Rheumatology outpatient clinic of Uludag University Faculty of Medicine. The study included adult patients diagnosed with rheumatic diseases who were receiving either biologic DMARDs (bDMARDs) or conventional DMARDs (cDMARDs).
During the COVID-19 pandemic period, patients were contacted by telephone and informed about the study. Verbal consent was obtained prior to data collection. Demographic and clinical characteristics were recorded using a structured patient information form.
Coronavirus-related anxiety was assessed using the validated Coronavirus Anxiety Scale. The primary objective was to compare anxiety scores between patients receiving biologic and conventional DMARD therapy. Secondary analyses explored patients' perceptions of infection risk and their experiences during the pandemic period.
No intervention, treatment modification, or additional clinical procedure was performed. The study design is observational, and all data were collected at a single time point.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Türkiye
-
Bursa, Türkiye, Turkey (Türkiye), 16600
- Bursa City Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≥18 years
- Diagnosis of rheumatic disease
- Currently receiving biologic or conventional disease-modifying antirheumatic drugs (DMARDs)
- Followed at the rheumatology outpatient clinic during the COVID-19 pandemic period
- Provided verbal informed consent
Exclusion Criteria:
- Age <18 years
- Inability to complete telephone interview
- Cognitive impairment preventing reliable questionnaire response
- Refusal to participate
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Biologic DMARD group (bDMARD)
Adult rheumatology patients receiving biologic disease-modifying antirheumatic drugs
|
Participants are grouped based on their current prescribed DMARD regimen; no study intervention is administered.
|
|
Conventional DMARD group (cDMARD)
Adult rheumatology patients receiving conventional disease-modifying antirheumatic drugs
|
Participants are grouped based on their current prescribed DMARD regimen; no study intervention is administered.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Coronavirus Anxiety Scale Score
Time Frame: Baseline
|
Anxiety level measured using the validated Coronavirus Anxiety Scale (CAS).
The total score ranges from 0 to 20, with higher scores indicating greater coronavirus-related anxiety.
|
Baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Musculoskeletal Diseases
- Mental Disorders
- Connective Tissue Diseases
- Respiratory Tract Infections
- Infections
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Pneumonia, Viral
- Pneumonia
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- Skin and Connective Tissue Diseases
- COVID-19
- Anxiety Disorders
- Rheumatic Diseases
Other Study ID Numbers
- 2026-Rheumatology-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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