Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

COVID-19 Impact on Rheumatic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04407299
Recruitment Status : Completed
First Posted : May 29, 2020
Last Update Posted : July 15, 2020
Sponsor:
Collaborator:
Zagazig University
Information provided by (Responsible Party):
Mervat Eissa, Cairo University

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.

Condition or disease Intervention/treatment
COVID Behavioral: self-administered structured questionnaire

Detailed Description:

To assess the impact of coronavirus disease 2019 (COVID19) pandemic on the attitude, behaviour and mental health of rheumatic patients and to compare them with healthy individual. This is cross-sectional survey, 360 participants were included and divided into cases group composed of 180 patients with rheumatic diseases and control group composed of 180 healthy people. Data were collected via a self-administered structured questionnaire (Google form) which was sent to participants via social networks and emails to different rheumatic patients and healthy individuals. Mental health was measured by the five-item Brief Symptom Rating Scale (BSRS-5).

Conclusion: Mental health should be addressed in the same manner we deal with the infectious disease itself, being of no less importance. It is essential for mental health professionals provide psychological support to vulnerable populations, including the infected and chronically ill patients and their families, individuals, communities and health care workers.

Layout table for study information
Study Type : Observational
Actual Enrollment : 360 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Impact of COVID-19 Pandemic on Attitude, Behaviour and Mental Health of Patients With Rheumatic Diseases
Actual Study Start Date : April 20, 2020
Actual Primary Completion Date : May 10, 2020
Actual Study Completion Date : May 20, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

Group/Cohort Intervention/treatment
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
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.

2
control group composed of 180 healthy individuals (matched for age and sex)
Behavioral: self-administered structured questionnaire
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.




Primary Outcome Measures :
  1. Score of five-item Brief Symptom Rating Scale (BSRS-5) [ Time Frame: 3 weeks ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-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
Criteria

Inclusion Criteria:

  • adult patient with diagnosed rheumatic disease

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04407299


Locations
Layout table for location information
Egypt
Kasr Alainy Hospital
Cairo, Non-US/Non-Canadian, Egypt, 15551
Sponsors and Collaborators
Cairo University
Zagazig University
Investigators
Layout table for investigator information
Principal Investigator: Mervat Eissa Cairo University
Layout table for additonal information
Responsible Party: Mervat Eissa, Associate Prpfessor, Cairo University
ClinicalTrials.gov Identifier: NCT04407299    
Other Study ID Numbers: COVID-19Rheum
First Posted: May 29, 2020    Key Record Dates
Last Update Posted: July 15, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mervat Eissa, Cairo University:
Rheumatic patients
COVID-19
behaviour
Mental health
Additional relevant MeSH terms:
Layout table for MeSH terms
Rheumatic Diseases
Musculoskeletal Diseases
Connective Tissue Diseases