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Completed

NCT Number: NCT04949035

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

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

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Key information

Conditions

Covid19 Anxiety Disorders COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Mental Disorders Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

30 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Ministry of the Interior and Administration Hospital

Głuchołazy, 48-340, Poland

About this study

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 ?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  1. Six-Minute Walk Test (6MWT)

    Time frame: 10 minutes

    The six-minute walk test measures the distance a patient is able to walk over a total of six minutes on a firm, flat surface. The aim is for the patient to walk as far as possible in six minutes. The patient is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway.

  2. Spirometry Test

    Time frame: 20 minutes

    The patient is asked to take the deepest breath they can, and then exhale into the sensor as hard as possible, for as long as possible, preferably at least 6 seconds. It is sometimes directly followed by a rapid inhalation, in particular when assessing possible upper airway obstruction.

Sponsors and collaborators

Lead sponsor

The Opole University of Technology

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 2, 2021
Registry last updated
Aug 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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