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Completed

NCT Number: NCT04546191

Symptoms and Wellbeing of People Infected With Covid-19 Virus in Iceland

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Landspitali National University Hospital

Reykjavik, Ísland, 1071, Iceland

About this study

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?

Who can participate

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

Inclusion criteria

  • Patients receiving care from the COVID-19 outpatient clinic at LUH during the first wave of the pandemic

Exclusion criteria

  • Young than 18 y.o.
  • Do not understand Icelandic
  • Died

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Wellbeing - HRQL

    Time frame: 2 months

    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).

Other outcomes

  1. Anxiety and depression (HADS)

    Time frame: 2 months

    Hospital Anxiety and Depression Scale (HADS) is a widely used instrument to assess anxiety and depression in people attending outpatient hospital clinics. Sensitive to mild disturbances, HADS is a reliable and valid instrument consisting of a 14 item 4 point (0-3) Likert scale with two subscales; anxiety (7 items) and depression (7 items). The minimum score is 0 and the highest possible score is 42. Higher score refers to worse outcome.

Sponsors and collaborators

Lead sponsor

Landspitali University Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 11, 2020
Registry last updated
Sep 16, 2020

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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