COVIDNCT04407299
COVID-19 Impact on Rheumatic Patients
An observational study of COVID, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- COVID
- What is being tested?
- self-administered structured questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 360 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Apr 2020to 20 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Child, Adult, Older adult
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
Who may be able to join
- adult patient with diagnosed rheumatic disease
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of COVID-19 Pandemic on Attitude, Behaviour and Mental Health of Patients With Rheumatic Diseases
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.
Read the 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.
- Conditions
- COVID
- Being tested
- self-administered structured questionnaire
- Keywords
- Rheumatic patients, COVID-19, behaviour, Mental health
- Medical subject headings
- COVID-19, Behavior, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-administered structured questionnaireBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: self-administered structured questionnaire | |
| 2 | control group composed of 180 healthy individuals (matched for age and sex) Receives: Behavioral: self-administered structured questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of five-item Brief Symptom Rating Scale (BSRS-5)
- 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
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start20 Apr 2020
- Primary completion10 May 2020
- Study completion20 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Zagazig University
- Responsible party
- Principal investigator, Mervat Eissa, Cairo University
- Investigators
- Mervat Eissa, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04407299
- Sponsor's protocol ID
- COVID-19Rheum
- Status last verified
- Jul 2020
- First submitted
- 23 May 2020
- Last updated
- 15 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of COVID-19 Pandemic on Attitude, Behaviour and Mental Health of Patients With Rheumatic Diseases
- ClinicalTrials.gov ID
- NCT04407299
- Acronym / sponsor ID
- COVID-19Rheum
- Conditions
- COVID
- Keywords
- Rheumatic patients, COVID-19, behaviour, Mental health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Zagazig University
- Study start
- 20 Apr 2020 (actual)
- Primary completion
- 10 May 2020 (actual)
- Study completion
- 20 May 2020 (actual)
- First posted
- 29 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Behavioral: self-administered structured questionnaire180 patients diagnosed with autoimmune rheumatic disease. Patients are RA SLE Rhupus AS Behcet Sjogren Vasculitis FM Polymyalgia APA Sarcoidosis IBD Scleroderma DM PSA Mixed |
| 2 | – | Behavioral: self-administered structured questionnairecontrol group composed of 180 healthy individuals (matched for age and sex) |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- adult patient with diagnosed rheumatic disease
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| self-administered structured questionnaireIt was designed as a self-administered questionnaire with closed questions (yes/no questions, rating scale and multiple choice questions) and some open ended questions. | Behavioural | 1, 2 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mervat Eissa principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score of five-item Brief Symptom Rating Scale (BSRS-5) (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2020.