Covid19NCT04949035
Mental Status and Quality of Life of Post-COVID-19 Patients
An observational study of Covid19, run by The Opole University of Technology at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Covid19
- What is being tested?
- Assessment of mental state and quality of life
- How many people
- 147 participants
- Where
- 1 sitePoland
- Study dates
- 1 Mar 2021to 7 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Previously hospitalized for SARS-CoV-2 infection;
- Pulmonary rehabilitation conducted in ward settings
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Poland1 site
The Ministry of the Interior and Administration Hospital
Głuchołazy, 48-340
About this study
Official title: Assessment of Mental Status and Quality of Life of Patients Admitted to the Rehabilitation Unit After COVID-19 Hospitalization
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
Read the 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 ?
- Conditions
- Covid19
- Being tested
- Assessment of mental state and quality of life
- Keywords
- quality of life, HADS, rehabilitation, anxiety
- Medical subject headings
- COVID-19, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of mental state and quality of lifeDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 survivors | Not described Receives: Diagnostic Test: Assessment of mental state and quality of life |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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".
Measured: 10 minutes
Secondary outcomes (2)
Six-Minute Walk Test (6MWT)
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.
Measured: 10 minutes
Spirometry Test
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.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start1 Mar 2021
- Primary completion28 May 2021
- Study completion7 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Opole University of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sebastian Rutkowski, The Opole University of Technology
- Investigators
- Joanna Szczepańska-Gieracha, Prof, Study director, University School of Physical Education, Department of Physiotherapy, Wroclaw, PolandSebastian Rutkowski, PhD, Study chair, The Opole University of Technology, Opole, PolandPatryk Szary, MSc, Principal investigator, University School of Physical Education, Department of Physiotherapy, Wroclaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04949035
- Sponsor's protocol ID
- COVID-19 Pre-
- Status last verified
- Aug 2021
- First submitted
- 1 Jul 2021
- Last updated
- 9 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Mental Status and Quality of Life of Patients Admitted to the Rehabilitation Unit After COVID-19 Hospitalization
- ClinicalTrials.gov ID
- NCT04949035
- Acronym / sponsor ID
- COVID-19 Pre-
- Conditions
- Covid19
- Keywords
- quality of life, HADS, rehabilitation, anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- The Opole University of TechnologyUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 28 May 2021 (actual)
- Study completion
- 7 Jun 2021 (actual)
- First posted
- 2 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 ?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19 survivors | – | Diagnostic Test: Assessment of mental state and quality of life |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Previously hospitalized for SARS-CoV-2 infection;
- Pulmonary rehabilitation conducted in ward settings
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of mental state and quality of lifePatients qualified for rehabilitation will be assessed for stress levels as well as symptoms of anxiety and depression and quality of life before rehabilitation began | Diagnostic test | COVID-19 survivors |
Primary outcome
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.
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.
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".
2 secondary outcomes
Six-Minute Walk Test (6MWT)
Time frame: 10 minutes
Spirometry Test
Time frame: 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joanna Szczepańska-Gieracha, Prof study director
University School of Physical Education, Department of Physiotherapy, Wroclaw, Poland
Sebastian Rutkowski, PhD study chair
The Opole University of Technology, Opole, Poland
Patryk Szary, MSc principal investigator
University School of Physical Education, Department of Physiotherapy, Wroclaw, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by The Opole University of Technology at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Anxiety and Depression Scale (HADS) (time frame: 15 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2021.