Clinical trial NCT04949035: Mental Status and Quality of Life of Post-COVID-19 Patients
Official title: Assessment of Mental Status and Quality of Life of Patients Admitted to the Rehabilitation Unit After COVID-19 Hospitalization
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Keywords: quality of life
HADS
rehabilitation
anxiety
Lead sponsor: The Opole University of Technology
Sponsor class: OTHER
First posted: 2021-07-02
Enrollment: 147
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COVID-19 caused by SARS-CoV-2 has led to a global public health crisis. Clinical symptoms of patients with COVID-19 infection include fever, sore throat, coughing, fatigue, or gastrointestinal infections, which can appear in a smaller population of patients. In more severe cases, respiratory failure symptoms, as well as heart and kidney damage, may occur. This can happen especially in the elderly and in people with other concomitant chronic diseases. Furthermore, the COVID-19 pandemic gives rise to new psychosocial and emotional stressors for recovering patients, including social isolation, physical distancing, loss of employment and uncertainties about the future. Remarkably, many mental problems will continue long after the pandemic is over, some of which will only begin to emerge in the near future.

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 ?

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.

Primary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 15 minutes
measure: Perceived stress scale (PSS-10)
timeFrame: 15 minutes
measure: WHOQOL-BREF
timeFrame: 10 minutes
Secondary outcomes:
measure: Six-Minute Walk Test (6MWT)
timeFrame: 10 minutes
measure: Spirometry Test
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Głuchołazy
country: Poland
facility: The Ministry of the Interior and Administration Hospital
Study officials:
affiliation: University School of Physical Education, Department of Physiotherapy, Wroclaw, Poland
name: Joanna Szczepańska-Gieracha, Prof
role: STUDY_DIRECTOR
affiliation: The Opole University of Technology, Opole, Poland
name: Sebastian Rutkowski, PhD
role: STUDY_CHAIR
affiliation: University School of Physical Education, Department of Physiotherapy, Wroclaw, Poland
name: Patryk Szary, MSc
role: PRINCIPAL_INVESTIGATOR
References: