NCT04407299

Brief Summary

A study to assess the impact of coronavirus disease 2019 (COVID-19) pandemic on the attitude, behaviour and mental health of rheumatic patients and to compare them with healthy individuals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
360

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 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

April 20, 2020

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2020

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2020

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 23, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 29, 2020

Completed
Last Updated

July 15, 2020

Status Verified

July 1, 2020

Enrollment Period

20 days

First QC Date

May 23, 2020

Last Update Submit

July 13, 2020

Conditions

Keywords

Rheumatic patientsCOVID-19behaviourMental health

Outcome Measures

Primary Outcomes (1)

  • Score of five-item Brief Symptom Rating Scale (BSRS-5)

    7\. Six questions for mental health assessment for patients and controls: Mental health was measured by the five-item Brief Symptom Rating Scale (BSRS-5) which was derived from the 50-item BSRS

    3 weeks

Study Arms (2)

1

180 patients diagnosed with autoimmune rheumatic disease. Patients are RA SLE Rhupus AS Behcet Sjogren Vasculitis FM Polymyalgia APA Sarcoidosis IBD Scleroderma DM PSA Mixed

Behavioral: self-administered structured questionnaire

2

control group composed of 180 healthy individuals (matched for age and sex)

Behavioral: self-administered structured questionnaire

Interventions

It was designed as a self-administered questionnaire with closed questions (yes/no questions, rating scale and multiple choice questions) and some open ended questions.

12

Eligibility Criteria

Age16 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

a total of 360 participants were included in this study and divided into two groups: cases group composed of 180 patients with rheumatic diseases and control group composed of 180 healthy individuals

You may qualify if:

  • adult patient with diagnosed rheumatic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Alainy Hospital

Cairo, Non-US/Non-Canadian, 15551, Egypt

Location

MeSH Terms

Conditions

COVID-19BehaviorPsychological Well-Being

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPersonal Satisfaction

Study Officials

  • Mervat Eissa

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Prpfessor

Study Record Dates

First Submitted

May 23, 2020

First Posted

May 29, 2020

Study Start

April 20, 2020

Primary Completion

May 10, 2020

Study Completion

May 20, 2020

Last Updated

July 15, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations