- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04949035
Mental Status and Quality of Life of Post-COVID-19 Patients
Assessment of Mental Status and Quality of Life of Patients Admitted to the Rehabilitation Unit After COVID-19 Hospitalization
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Głuchołazy, Poland, 48-340
- The Ministry of the Interior and Administration Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
COVID-19 survivors
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hospital Anxiety and Depression Scale (HADS)
Time Frame: 15 minutes
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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.
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15 minutes
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Perceived stress scale (PSS-10)
Time Frame: 15 minutes
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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.
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15 minutes
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WHOQOL-BREF
Time Frame: 10 minutes
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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".
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10 minutes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Six-Minute Walk Test (6MWT)
Time Frame: 10 minutes
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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.
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10 minutes
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Spirometry Test
Time Frame: 20 minutes
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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.
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20 minutes
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Collaborators and Investigators
Investigators
- Study Director: Joanna Szczepańska-Gieracha, Prof, University School of Physical Education, Department of Physiotherapy, Wroclaw, Poland
- Study Chair: Sebastian Rutkowski, PhD, The Opole University of Technology, Opole, Poland
- Principal Investigator: Patryk Szary, MSc, University School of Physical Education, Department of Physiotherapy, Wroclaw, Poland
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- COVID-19 Pre-
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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