Covid19NCT04546191
Symptoms and Wellbeing of People Infected With Covid-19 Virus in Iceland
An observational study of Covid19, run by Landspitali University Hospital at 1 site in Iceland.
Trial summary
The purpose of this cross-sectional study is to explore symptoms and well being of people diagnosed with COVID-19 from the outset of the pandemic until June 2020. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- How many people
- 1,580 participants
- Where
- 1 siteIceland
- Study dates
- 1 Jul 2020to 1 Sep 2020
- How long will I take part?
- 2 Months
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: All patients receiving care from the COVID-19 outpatient clinic at LUH during the first wave of the pandemic
Who may be able to join
- Patients receiving care from the COVID-19 outpatient clinic at LUH during the first wave of the pandemic
Who cannot join
- Young than 18 y.o.
- Do not understand Icelandic
- Died
Trial locations and contacts
1 site in 1 country.
Iceland1 site
Landspitali National University Hospital
Reykjavik, Ísland, 1071
About this study
The purpose of this cross-sectional study is to explore symptoms and well being of people diagnosed with COVID-19 from the outset of the pandemic until June 2020.
Read the detailed description
All patients diagnosed with COVID-19 in Iceland were referred to the COVID-19 outpatient clinic at Landspitali National University Hospital in Iceland. In the clinic risk assessment was conducted and the patients were accordingly provided with individualized care be it telephone surveillance, onsite examination and treatment, or admission to the hospital. As the the first wave of the pandemic was curbing the necessity of exploring how the patients did and continue to fare after being infected became apparent.
The research questions are:
What were the symptoms that patients expressed during and about three months after being diagnosed with COVID-19? What is the prevalence and intensity of the symptoms that patients expressed during and about three months after being diagnosed with COVID-19 ? How do patients value their health related quality of life, what is their health literacy and sense of security in care during and about three months after being diagnosed with COVID-19 ? How do patients value the nursing care in the outpatient COVID-19 clinic? What are the patients' perception of having caught COVID-19?
- Conditions
- Covid19
- Keywords
- Covid19, Symptoms, Well being, Survey
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms
Patients answer a questionnaire developed by authors based on published symptoms of COPVID19. The questionnare has two versions one refers to symptoms during the quarantine and the other to the time a couple of months later. Name: Symptoms during and after the COVID 19 quarantine.
The questionnaire has 25 items scored on a four point Likert scale. The highest possible score is 100 and the lowest possible score is 20. Higher score means worse outcome.
Measured: 2 months
Secondary outcomes (1)
Wellbeing - HRQL
EQ-5D is a generic health related quality of life measurement (HRQL). It is composed of five dimensions; mobility, self-care, usual activities, pain/discomfort and anxiety/depression measured on five levels (from no problems to extreme problems or unable) with a minimum score 5 and maximum score 25, with higher score indicating worse outcome. The instrument contains as well a visual analogue scale (VAS) measuring the person's "health state today", on a 100 point scale (worst imaginable to best imaginable health state).
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2020
- Study start1 Jul 2020
- Primary completion1 Sep 2020
- Study completion1 Sep 2020
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
- Cross-sectional
- Enrolment
- 1,580 participants (actual)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Landspitali University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helga Jónsdóttir, Landspitali University Hospital
- Investigators
- Brynja Ingadottir, PhD, Principal investigator, Faculty of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04546191
- Sponsor's protocol ID
- LSH-20-002
- Status last verified
- Sep 2020
- First submitted
- 10 Sep 2020
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptoms and Wellbeing of People Infected With Covid-19 Virus in Iceland
- ClinicalTrials.gov ID
- NCT04546191
- Acronym / sponsor ID
- LSH-20-002
- Conditions
- Covid19
- Keywords
- Covid19, Symptoms, Well being, Survey
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,580 participants (actual)
- Lead sponsor
- Landspitali University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 11 Sep 2020 (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 purpose of this cross-sectional study is to explore symptoms and well being of people diagnosed with COVID-19 from the outset of the pandemic until June 2020.
Detailed description
All patients diagnosed with COVID-19 in Iceland were referred to the COVID-19 outpatient clinic at Landspitali National University Hospital in Iceland. In the clinic risk assessment was conducted and the patients were accordingly provided with individualized care be it telephone surveillance, onsite examination and treatment, or admission to the hospital. As the the first wave of the pandemic was curbing the necessity of exploring how the patients did and continue to fare after being infected became apparent.
The research questions are:
What were the symptoms that patients expressed during and about three months after being diagnosed with COVID-19? What is the prevalence and intensity of the symptoms that patients expressed during and about three months after being diagnosed with COVID-19 ? How do patients value their health related quality of life, what is their health literacy and sense of security in care during and about three months after being diagnosed with COVID-19 ? How do patients value the nursing care in the outpatient COVID-19 clinic? What are the patients' perception of having caught COVID-19?
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients receiving care from the COVID-19 outpatient clinic at LUH during the first wave of the pandemic
Key inclusion criteria (1 listed)
- Patients receiving care from the COVID-19 outpatient clinic at LUH during the first wave of the pandemic
Key exclusion criteria (3 listed)
- Young than 18 y.o.
- Do not understand Icelandic
- Died
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Symptoms
Time frame: 2 months
Patients answer a questionnaire developed by authors based on published symptoms of COPVID19. The questionnare has two versions one refers to symptoms during the quarantine and the other to the time a couple of months later. Name: Symptoms during and after the COVID 19 quarantine. The questionnaire has 25 items scored on a four point Likert scale. The highest possible score is 100 and the lowest possible score is 20. Higher score means worse outcome.
1 secondary outcome
Wellbeing - HRQL
Time frame: 2 months
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 16 Sep 2020.
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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.
Brynja Ingadottir, PhD principal investigator
Faculty of Nursing
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 Landspitali University Hospital at 1 site in Iceland.
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 1 inclusion and 3 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 16 Sep 2020. 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 Iceland. 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?
Symptoms (time frame: 2 months). 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 16 Sep 2020.