Development of an International COVID-19 Specific Quality of Life Questionnaire, Phase III. The OSLO COVID-19 QLQ

Purpose: to develop an international validated patient-reported outcome measure for COVID-19 patients according to international guidelines.

In this phase III of the project, the preliminary questionnaire of 80 items will be tested. It has been developed based on literature review and interviews with health care professionals and patients (phase I-II).

In Phase III A patients will fill in the questionnaire followed by interviews on relevance, importance and wording of the questionnaire In Phase III B patients will fill in the questionnaire and an debriefing questionnaire. We will do explorative psychometric analyses.

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Key information

Conditions

Covid19, Patient Reported Outcome Measures, Quality of Life 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

Oslo University Hospital

Oslo, N-0424, Norway

About this study

This project aim to develop an international validated patient-reported outcome measure for COVID-19 patients according to international guidelines. The Phase I and II of this development process have been finalized. Based on a systematic literature review , interviews with 44 health-care professionals and 52 patients in 6-7 countries a final list of 80 questions, the preliminary Oslo COVID-19 QLQ - PW80 ©, is ready to be tested in the current Phase III of the development process.

The objectives of the phase III are:

In a limited patient group, to check that the items make sense to the target population, that the phrasing and sequence of questions is acceptable, that there are no missing issues and that none of the questions are confusing and/or offensive (Phase IIIA).
In addition, in a larger patient group, to test hypothesized subscales for psychometric properties including reliability, prevalence and variance (e.g. Cronbach's alpha coefficient and correlation-based methods) (Phase IIIB).

The end-product, the international COVID-19- specific questionnaire, will be a psychometrically robust patient-reported outcome measure (PROM) to assess HRQoL in patients with or after COVID-19 disease

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients with verified SARS-CoV-2 infection (positive test according to local/national standards)
Patients with active or previous symptomatic COVID-19 disease
In-patients in hospitals and nursing homes or out-patients in hospitals or patients discharged from institutions to their home/covid-19 centres or patients staying at home/covid-19 centres during the course of the disease
Patients aged 18 years and older
Ability to read and comprehend the process and study documents as judged by the investigator
Written informed consent

Exclusion criteria

Patients in intensive care units (can be recruited after they have been dismissed)
Inability to read and comprehend the process and study documents as judged by the investigator

Treatment and study plan

No intervention. Method study. Psychometric testing

Other

Patients will fill in the questionnaire followed by an interview (phase IIIA) or a debriefing questionnaire (Phase IIIB)

Primary outcomes

Validated COVID-19 specific questionnaire

Time frame: 6 months

Instrument that can be used in international intervention and observational studies on patients with COVID-19 disease

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

Birzeit University
European Organisation for Research and Treatment of Cancer - EORTC
Haukeland University Hospital
Johannes Gutenberg University Mainz
Komfo Anokye Teaching Hospital
Medical University Innsbruck
National Centre for Infectious Diseases
Servicio de Navarro de Salud
Skane University Hospital
Sumandeep Vidyapeeth
University of Southampton
University of the East Ramon Magsaysay Memorial Medical Center

Registry information

Official study title

Development of an International Questionnaire to Assess Patient-reported Quality of Life Related to COVID-19 Disease, the Oslo COVID-19 Quality of Life Questionnaire (QLQ) - ## © Phase III of Questionnaire Development

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2022
First posted: Feb 5, 2021
Registry last updated: Jan 3, 2024

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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Completed