SARS-CoV-2NCT04753463
Assessment of the Impact of COVID-19 Pandemic on Residents Training and Mental Health in Poland
An observational study of SARS-CoV-2, run by Medical University of Bialystok at 2 sites in Poland.
Trial summary
The aim of study is to investigate the impact of SARS-CoV-2 on ophthalmology training programs among residents. To the best of our knowledge this study is the first of its kind in Poland. Read more about this study
- Who is it for?
- Ages 25 to 35 years
- Conditions the study is for
- SARS-CoV-2
- What is being tested?
- Survey
- How many people
- 126 participants
- Where
- 2 sitesPoland
- Study dates
- 15 Mar 2021to 15 Apr 2021
- 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 25 to 35 years
- All sexes
- Adult
Study population: Residents of ophthalmology (male and female), in the age of 25-35 working on ophthalmology departments
Who may be able to join
- male and female in the age of 25-35 during residence training
Who cannot join
- lack of consent for participating in survey
Trial locations and contacts
2 sites in 1 country.
Poland2 sites
Medical University
Bialystok, 15-089
Ophthalmology Clinic Medical University of Bialystok
Bialystok, 15-089
About this study
The aim of study is to investigate the impact of SARS-CoV-2 on ophthalmology training programs among residents. To the best of our knowledge this study is the first of its kind in Poland. The impact of COVID-19 on ophthalmology training programs is largely unknown as there are only few studies assessing the above issue from the resident's point of view.
Read the detailed description
The novel coronavirus SARS-CoV-2, responsible for Coronavirus Disease 2019 (COVID-19), was first identified at the end of the year 2019 in Wuhan (China). A rapid spread of the disease resulted in global threat to public health. On 11 March 2020 the World Health Organization (WHO) announced the state of pandemic. In Poland, the first confirmed case of COVID-19 was reported on 4 March 2020 and subsequent growing number of patients has placed tremendous strain on healthcare system. The crisis situation prompted immediate action to divert healthcare resources for the treatment of patients with COVID-19 and to limit the spread of the infection. In accordance with the decision of the Minister of Health of March 13th, 2020, more than twenty hospitals were established to admit only the SARS-CoV-2 affected patients. Moreover, all hospitals were recommended to limit their planned activity and to perform only urgent and emergency services.
The investigators hypothesize that those changes in healthcare system and restrictions established in public area during pandemic caused significant difficulties in residency training considering clinical and surgical practice as well as didactic activities. In spite of gradual reopening the routine services over the last few months, social distancing rules are still in force. Accordingly, different methods of virtual teaching were introduced including, inter alia, organisation of courses, lectures and conferences in form of on-line meetings.
The aim of current study is to investigate the impact of SARS-CoV-2 on ophthalmology training programs among residents. To the best of our knowledge this study is the first of its kind in Poland. The impact of COVID-19 on ophthalmology training programs is largely unknown as there are only few studies assessing the above issue from the resident's point of view.
The investigators believe that this investigations will address this gap in the literature and could be used to initiate the new solutions in order to maintain successful residency training during pandemic. Opinions regarding the efficiency of e-learning methods and on-line meetings may be crucial to innovate the conventional teaching way permanently in the future.
- Conditions
- SARS-CoV-2
- Being tested
- Survey
- Keywords
- Residents training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
The on-line questionnaire which assess the subjective feelings of residents of pandemic impact on ophthalmology training programs
| Study group | Role | What they receive |
|---|---|---|
| Residents of Ophthalmology working on COVID-19 departments | Residents of ophthalmology working on COVID-19 departments and dealing with SARS-CoV-2 positive patients Receives: Other: Survey | |
| Residents of Ophthalmology working on general ophthalmic departments | Residents of Ophthalmology working on general ophthalmic departments and not dealing with SARS-CoV-2 positive patients Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
questionnaire assessing the incidence of disturbance of COVID-19 pandemic on ophthalmology training programs among residents
the opinion of ophthalmology training programs among residents assessed with the questionnaire collecting demographics (age, gender), domicile (state, union territory), current professional status (in training or practising), type of practice (solo, group, institutional, governmental, non-governmental), marital status (married, single), impact of COVID-19 on their training or ophthalmology practice, and impact on income and ability to meet living expense
Measured: 1 month
Secondary outcomes (2)
questionnaire assessing the negative impact of COVID-19 pandemic on mental health among ophthalmology residents
the opinion on impact for mental health among residents assessed with the Patient Health Questionnaire-9 (PHQ-9). PHQ-9 is a selfreport measure that is used to assess the severity of depression over the prior 2 weeks. Response to the nine questions are graded as 0 (not at all), 1 (several days), 2 (more than half the days), and 3 (nearly every day). The total score of PHQ-9 that categorizes depression is as follows: minimal/no depression (0-4), mild depression (5-9), moderate depression (10-14), or severe depression (15-21).
Measured: 1 month
questionnaire assessing the attitude on COVID-19 vaccination of ophthalmology residents
the attitude towards the vaccination against the SARS-CoV-2 among residents assessed with the questionnaire with open questions about the willingness of taking the vaccination
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start15 Mar 2021
- Primary completion28 Mar 2021
- Study completion15 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV-2Studies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Bialystok
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marek MD Rękas, Prof, Study chair, Wojskowy Instytut Medyczny
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04753463
- Sponsor's protocol ID
- 1775
- Status last verified
- Sep 2021
- First submitted
- 4 Feb 2021
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant data that underlie the results reported in this article are available upon reasonable request for academic and non-commercial purposes beginning with article publication and ending 5 years thereafter. Proposals should be submitted to joannakonopinska@o2.pl for review and approval by an internal steering committee. Qualified researchers with reasonable proposals will be provided access to the data along with the redacted study protocol and statistical analysis plan to achieve the specified aims in their approved proposal after signing a data access agreement.
Publications
Silva N, Laiginhas R, Meireles A, Barbosa Breda J. Impact of the COVID-19 Pandemic on Ophthalmology Residency Training in Portugal. Acta Med Port. 2020 Oct 1;33(10):640-648. doi: 10.20344/amp.14341. Epub 2020 Sep 10.
PubMed 32914750Mishra D, Nair AG, Gandhi RA, Gogate PJ, Mathur S, Bhushan P, Srivastav T, Singh H, Sinha BP, Singh MK. The impact of COVID-19 related lockdown on ophthalmology training programs in India - Outcomes of a survey. Indian J Ophthalmol. 2020 Jun;68(6):999-1004. doi: 10.4103/ijo.IJO_1067_20.
PubMed 32461413El-Saied HMA, Salah Eddin Abdelhakim MA. Impact of COVID-19 Pandemic on Young Ophthalmologists in Cairo University Hospitals. Semin Ophthalmol. 2020 Aug 17;35(5-6):296-306. doi: 10.1080/08820538.2020.1826046. Epub 2020 Oct 5.
PubMed 33017198
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Impact of COVID-19 Pandemic on Residents Training and Mental Health in Poland
- ClinicalTrials.gov ID
- NCT04753463
- Acronym / sponsor ID
- 1775
- Conditions
- SARS-CoV-2
- Keywords
- Residents training
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Medical University of BialystokUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 28 Mar 2021 (actual)
- Study completion
- 15 Apr 2021 (actual)
- First posted
- 15 Feb 2021 (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.
The aim of study is to investigate the impact of SARS-CoV-2 on ophthalmology training programs among residents. To the best of our knowledge this study is the first of its kind in Poland. The impact of COVID-19 on ophthalmology training programs is largely unknown as there are only few studies assessing the above issue from the resident's point of view.
Detailed description
The novel coronavirus SARS-CoV-2, responsible for Coronavirus Disease 2019 (COVID-19), was first identified at the end of the year 2019 in Wuhan (China). A rapid spread of the disease resulted in global threat to public health. On 11 March 2020 the World Health Organization (WHO) announced the state of pandemic. In Poland, the first confirmed case of COVID-19 was reported on 4 March 2020 and subsequent growing number of patients has placed tremendous strain on healthcare system. The crisis situation prompted immediate action to divert healthcare resources for the treatment of patients with COVID-19 and to limit the spread of the infection. In accordance with the decision of the Minister of Health of March 13th, 2020, more than twenty hospitals were established to admit only the SARS-CoV-2 affected patients. Moreover, all hospitals were recommended to limit their planned activity and to perform only urgent and emergency services.
The investigators hypothesize that those changes in healthcare system and restrictions established in public area during pandemic caused significant difficulties in residency training considering clinical and surgical practice as well as didactic activities. In spite of gradual reopening the routine services over the last few months, social distancing rules are still in force. Accordingly, different methods of virtual teaching were introduced including, inter alia, organisation of courses, lectures and conferences in form of on-line meetings.
The aim of current study is to investigate the impact of SARS-CoV-2 on ophthalmology training programs among residents. To the best of our knowledge this study is the first of its kind in Poland. The impact of COVID-19 on ophthalmology training programs is largely unknown as there are only few studies assessing the above issue from the resident's point of view.
The investigators believe that this investigations will address this gap in the literature and could be used to initiate the new solutions in order to maintain successful residency training during pandemic. Opinions regarding the efficiency of e-learning methods and on-line meetings may be crucial to innovate the conventional teaching way permanently in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Residents of Ophthalmology working on COVID-19 departments | – | Other: SurveyResidents of ophthalmology working on COVID-19 departments and dealing with SARS-CoV-2 positive patients |
| Residents of Ophthalmology working on general ophthalmic departments | – | Other: SurveyResidents of Ophthalmology working on general ophthalmic departments and not dealing with SARS-CoV-2 positive patients |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- All
- Age groups
- Adult
- Study population
- Residents of ophthalmology (male and female), in the age of 25-35 working on ophthalmology departments
Key inclusion criteria (1 listed)
- male and female in the age of 25-35 during residence training
Key exclusion criteria (1 listed)
- lack of consent for participating in survey
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 |
|---|---|---|
| SurveyThe on-line questionnaire which assess the subjective feelings of residents of pandemic impact on ophthalmology training programs | Other | Residents of Ophthalmology working on COVID-19 departments, Residents of Ophthalmology working on general ophthalmic departments |
Primary outcome
questionnaire assessing the incidence of disturbance of COVID-19 pandemic on ophthalmology training programs among residents
Time frame: 1 month
the opinion of ophthalmology training programs among residents assessed with the questionnaire collecting demographics (age, gender), domicile (state, union territory), current professional status (in training or practising), type of practice (solo, group, institutional, governmental, non-governmental), marital status (married, single), impact of COVID-19 on their training or ophthalmology practice, and impact on income and ability to meet living expense
2 secondary outcomes
questionnaire assessing the negative impact of COVID-19 pandemic on mental health among ophthalmology residents
Time frame: 1 month
questionnaire assessing the attitude on COVID-19 vaccination of ophthalmology residents
Time frame: 1 month
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 28 Sep 2021.
- Results publication: PubMed 32914750Silva N, Laiginhas R, Meireles A, Barbosa Breda J. Impact of the COVID-19 Pandemic on Ophthalmology Residency Training in Portugal. Acta Med Port. 2020 Oct 1;33(10):640-648. doi: 10.20344/amp.14341. Epub 2020 Sep 10.
- Results publication: PubMed 32461413Mishra D, Nair AG, Gandhi RA, Gogate PJ, Mathur S, Bhushan P, Srivastav T, Singh H, Sinha BP, Singh MK. The impact of COVID-19 related lockdown on ophthalmology training programs in India - Outcomes of a survey. Indian J Ophthalmol. 2020 Jun;68(6):999-1004. doi: 10.4103/ijo.IJO_1067_20.
- Results publication: PubMed 33017198El-Saied HMA, Salah Eddin Abdelhakim MA. Impact of COVID-19 Pandemic on Young Ophthalmologists in Cairo University Hospitals. Semin Ophthalmol. 2020 Aug 17;35(5-6):296-306. doi: 10.1080/08820538.2020.1826046. Epub 2020 Oct 5.
- Individual participant dataSharing planned: Yes. De-identified participant data that underlie the results reported in this article are available upon reasonable request for academic and non-commercial purposes beginning with article publication and ending 5 years thereafter. Proposals should be submitted to joannakonopinska@o2.pl for review and approval by an internal steering committee. Qualified researchers with reasonable proposals will be provided access to the data along with the redacted study protocol and statistical analysis plan to achieve the specified aims in their approved proposal after signing a data access agreement.
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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.
Marek MD Rękas, Prof study chair
Wojskowy Instytut Medyczny
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV-2, run by Medical University of Bialystok at 2 sites in Poland.
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 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. 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?
questionnaire assessing the incidence of disturbance of COVID-19 pandemic on ophthalmology training programs among residents (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04753463, which also lists 3 linked publications.
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 28 Sep 2021.