NCT07436494

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2021

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2021

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

February 12, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

3 months

First QC Date

February 12, 2026

Last Update Submit

February 21, 2026

Conditions

Keywords

Biologic DMARDConventional DMARDCoronavirus Anxiety ScaleRheumatologyPandemic

Outcome Measures

Primary Outcomes (1)

  • Coronavirus Anxiety Scale Score

    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

Study Arms (2)

Biologic DMARD group (bDMARD)

Adult rheumatology patients receiving biologic disease-modifying antirheumatic drugs

Other: Current treatment (no intervention assigned)

Conventional DMARD group (cDMARD)

Adult rheumatology patients receiving conventional disease-modifying antirheumatic drugs

Other: Current treatment (no intervention assigned)

Interventions

Participants are grouped based on their current prescribed DMARD regimen; no study intervention is administered.

Biologic DMARD group (bDMARD)Conventional DMARD group (cDMARD)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with established rheumatic diseases under treatment with biologic or conventional DMARD therapy who were actively followed at a tertiary care rheumatology outpatient clinic during the COVID-19 pandemic.

You may qualify if:

  • 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

You may not qualify if:

  • Age \<18 years
  • Inability to complete telephone interview
  • Cognitive impairment preventing reliable questionnaire response
  • Refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bursa City Hospital

Bursa, Türkiye, 16600, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19Anxiety DisordersRheumatic Diseases

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesMental DisordersMusculoskeletal DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 12, 2026

First Posted

February 27, 2026

Study Start

October 15, 2020

Primary Completion

January 15, 2021

Study Completion

January 25, 2021

Last Updated

February 27, 2026

Record last verified: 2026-02

Locations