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Clinical Trials/NCT04949035
NCT04949035
Completed
N/A

Assessment of Mental Status and Quality of Life of Patients Admitted to the Rehabilitation Unit After COVID-19 Hospitalization

The Opole University of Technology1 site in 1 country147 target enrollmentMarch 1, 2021
ConditionsCovid19

Overview

Phase
N/A
Intervention
Not specified
Conditions
Covid19
Sponsor
The Opole University of Technology
Enrollment
147
Locations
1
Primary Endpoint
Perceived stress scale (PSS-10)
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

The current SARS-CoV-2 virus pandemic has already affected the lives of every person on earth. Most of the information given in the media on a daily basis focuses on the pandemic aspects. Fear of getting sick arises in the population, and once infection occurs, numerous concerns arise over the course of the disease. For some patients, hospitalization and subsequent rehabilitation is needed due to complications from the disease. Besides the aspect of treating patients physically from the disease, the psychological aspects that often accompany patients during and after the disease are not addressed. Depressive and anxiety symptoms can follow patients for many years and can affect their quality of life. Thus, the purpose of this project is to assess the mental status of patients prior to the inpatient rehabilitation program

Detailed Description

Patients with COVID-19 or post-COVID-19 will have a need for rehabilitation during and directly after hospitalization. Data on safety and efficacy are lacking, as the number of COVID-19 survivors has increased rapidly. The Convergence of Opinion on Recommendations and Evidence process was used to make interim recommendations for the in-hospital rehabilitation and post-hospital phase in patients with COVID-19 and post-COVID-19 patients, respectively. The International Task Force (ITS) was established, including the European Respiratory Society (ERS) and key opinion leaders from the American Thoracic Society (ATS), as well as key opinion leaders in the field of lung rehabilitation. In its report, the ITS identified recommendations for the rehabilitation of patients with COVID-19 and post-COVID-19 patients. Majority of the experts recommended strongly (71%) or conditionally (24%) for COVID-19 survivors with symptoms of psychological distress at 6-8 weeks after discharge from the hospital receiving a formal psychological assessment. Therefore, this project aims to evaluate the mental status and quality of life of patients admitted to the rehabilitation unit, after COVID-19 hospitalization. In our project, we intend to answer the following questions: * What is the severity of depressive symptoms in individuals who have suffered COVID-19 ? * What is the severity of anxiety symptoms in individuals who have suffered COVID-19 ? * What is the level of perceived stress in individuals who have suffered COVID-19 ? * What is the quality of life of people in individuals who have suffered COVID-19 ?

Registry
clinicaltrials.gov
Start Date
March 1, 2021
End Date
June 7, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
The Opole University of Technology
Responsible Party
Principal Investigator
Principal Investigator

Sebastian Rutkowski

Assistant Professor

The Opole University of Technology

Eligibility Criteria

Inclusion Criteria

  • Previously hospitalized for SARS-CoV-2 infection;
  • Pulmonary rehabilitation conducted in ward settings

Exclusion Criteria

  • Inability to self-complete the research questionnaires;
  • Presence of the following issues at the time of the examination or in the medical data: disturbances of consciousness, psychotic symptoms or other serious psychiatric disorders
  • Initiation of psychiatric treatment during the research project;
  • Patient's refusal at any stage of the research project.

Outcomes

Primary Outcomes

Perceived stress scale (PSS-10)

Time Frame: 15 minutes

The Perceived Stress Scale (PSS) is the most widely used psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. Items were designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives.

Hospital Anxiety and Depression Scale (HADS)

Time Frame: 15 minutes

The Hospital Anxiety and Depression Scale (HADS) is a fourteen-item scale scoring from 0 to 3 for each item. The first seven items relate to anxiety (HADS-A), and the remaining seven items relate to depression (HADS-D). The global scoring ranges from 0 to 42 with a cut-off point of 8/21 for anxiety and 8/21 for depression. The higher the score, the greater anxiety or depression symptoms. HADS will be performed at the beginning and after four weeks of treatment.

WHOQOL-BREF

Time Frame: 10 minutes

The WHOQOL-BREF is a shorter version of the WHOQOL-100. Both were developed by the World Health Organisation (WHO) and published in 1995. It was developed over several years and from 15 centres around the world. The questions stem from multiple statements about quality of life, health and well-being from people with and without disease, and health professionals. It has been tested for reliability and validity. The WHOQOL-BREF is a self-administered questionnaire comprising 26 questions on the individual's perceptions of their health and well-being over the previous two weeks. Responses to questions are on a 1-5 Likert scale where 1 represents "disagree" or "not at all" and 5 represents "completely agree" or "extremely".

Secondary Outcomes

  • Six-Minute Walk Test (6MWT)(10 minutes)
  • Spirometry Test(20 minutes)

Study Sites (1)

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