Assessment of the Impact of COVID-19 Pandemic on Residents Training and Mental Health in Poland

September 22, 2021 updated by: Medical University of Bialystok
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
126

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Białystok, Poland, 15-089
        • Medical University
      • Białystok, Poland, 15-089
        • Ophthalmology Clinic Medical University of Bialystok

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

25 years to 35 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Residents of ophthalmology (male and female), in the age of 25-35 working on ophthalmology departments

Description

Inclusion Criteria:

  • male and female in the age of 25-35 during residence training

Exclusion Criteria:

  • lack of consent for participating in survey

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Residents of Ophthalmology working on COVID-19 departments
Residents of ophthalmology working on COVID-19 departments and dealing with SARS-CoV-2 positive patients
Other: Survey
The on-line questionnaire which assess the subjective feelings of residents of pandemic impact on ophthalmology training programs
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
Other: Survey
The on-line questionnaire which assess the subjective feelings of residents of pandemic impact on ophthalmology training programs

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
1 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
questionnaire assessing the negative impact of COVID-19 pandemic on mental health among ophthalmology residents
Time Frame: 1 month
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).
1 month
questionnaire assessing the attitude on COVID-19 vaccination of ophthalmology residents
Time Frame: 1 month
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
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of Bialystok

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Marek MD Rękas, Prof, Wojskowy Instytut Medyczny

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 15, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 28, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 15, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 4, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 15, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 28, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1775

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

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.

IPD Sharing Time Frame

Since the time of publication up to 5 years

IPD Sharing Access Criteria

As above

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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