Mental Status and Quality of Life of Post-COVID-19 Patients

NCT04949035 | Completed

• 1 other identifier: COVID-19 Pre-
• Study Type: observational
• Target: 147
• Locations: 1 country
• Sites: 1

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

Conditions

Covid19

Keywords

quality of life; HADS; rehabilitation; anxiety

Outcome Measures

Primary Outcomes (3)

• Hospital Anxiety and Depression Scale (HADS)

  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.

  15 minutes

• Perceived stress scale (PSS-10)

  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.

  15 minutes

• WHOQOL-BREF

  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".

  10 minutes

Secondary Outcomes (2)

• Six-Minute Walk Test (6MWT)

  10 minutes

• Spirometry Test

  20 minutes

Study Arms (1)

COVID-19 survivors

Diagnostic Test: Assessment of mental state and quality of life

Interventions

Assessment of mental state and quality of life DIAGNOSTIC_TEST

Patients qualified for rehabilitation will be assessed for stress levels as well as symptoms of anxiety and depression and quality of life before rehabilitation began

COVID-19 survivors

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Opole University of Technology: lead

Study Sites (1)

The Ministry of the Interior and Administration Hospital

Głuchołazy, 48-340, Poland

Location

MeSH Terms

Conditions

COVID-19; Anxiety Disorders

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Mental Disorders

Study Officials

• Joanna Szczepańska-Gieracha, Prof

  University School of Physical Education, Department of Physiotherapy, Wroclaw, Poland

  STUDY DIRECTOR

• Sebastian Rutkowski, PhD

  The Opole University of Technology, Opole, Poland

  STUDY CHAIR

• Patryk Szary, MSc

  University School of Physical Education, Department of Physiotherapy, Wroclaw, Poland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: July 2, 2021
• Study Start: March 1, 2021
• Primary Completion: May 28, 2021
• Study Completion: June 7, 2021
• Last Updated: August 9, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)