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.

Study Overview

• Status: Completed
• Conditions: Covid19

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 Type: Observational
• Enrollment (Actual): 1580

Contacts and Locations

Study Locations

• Iceland
  • Ísland
    • Reykjavík, Ísland, Iceland, 1071
      • Landspitali National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	2 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety and depression (HADS)	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.	2 months

Collaborators and Investigators

• Sponsor: Landspitali University Hospital
• Investigators: Principal Investigator: Brynja Ingadottir, PhD, Faculty of Nursing

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): September 1, 2020
• Study Completion (Actual): September 1, 2020

Study Registration Dates

• First Submitted: September 10, 2020
• First Submitted That Met QC Criteria: September 10, 2020
• First Posted (Actual): September 11, 2020

Study Record Updates

• Last Update Posted (Actual): September 16, 2020
• Last Update Submitted That Met QC Criteria: September 11, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Covid19; Well being; Survey; Symptoms
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: LSH-20-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No