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

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: NCT04753463
Recruitment Status : Completed
First Posted : February 15, 2021
Last Update Posted : September 28, 2021
Sponsor:
Information provided by (Responsible Party):
Medical University of Bialystok

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment
SARS-CoV-2 Other: Survey

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
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Study Type : Observational
Actual Enrollment : 126 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of the Impact of COVID-19 Pandemic on Residents Training and Mental Health in Poland
Actual Study Start Date : March 15, 2021
Actual Primary Completion Date : March 28, 2021
Actual Study Completion Date : April 15, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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).

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   25 Years to 35 Years   (Adult)
Sexes 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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • lack of consent for participating in survey
Contacts and Locations
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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): NCT04753463


Locations
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Poland
Medical University
Białystok, Poland, 15-089
Ophthalmology Clinic Medical University of Bialystok
Białystok, Poland, 15-089
Sponsors and Collaborators
Medical University of Bialystok
Investigators
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Study Chair: Marek MD Rękas, Prof Wojskowy Instytut Medyczny
More Information
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Publications of Results:

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Responsible Party: Medical University of Bialystok
ClinicalTrials.gov Identifier: NCT04753463    
Other Study ID Numbers: 1775
First Posted: February 15, 2021    Key Record Dates
Last Update Posted: September 28, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Since the time of publication up to 5 years
Access Criteria: As above

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Medical University of Bialystok:
Residents training
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases