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

December 29, 2023 updated by: Cecilie Delphin Amdal, Oslo University Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
371

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Cecilie D Amdal, PhD
  • Phone Number: +4791517199
  • Email: cecia@ous-hf.no

Study Contact Backup

Study Locations

  • Norway
      • Oslo, Norway, N-0424
        • Oslo University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

To ensure content validity of the final questionnaire, the participants will be recruited according to specified recruitment matrices based on countries, language groups, age, gender, hospitalisation status, disease status and comorbidity.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oslo University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
European Organisation for Research and Treatment of Cancer - EORTC
University of Southampton
Haukeland University Hospital
Medical University Innsbruck
Johannes Gutenberg University Mainz
Skane University Hospital
Komfo Anokye Teaching Hospital
Servicio de Navarro de Salud
University of the East Ramon Magsaysay Memorial Medical Center
Sumandeep Vidyapeeth
Birzeit University
National Centre for Infectious Diseases

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 20, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 15, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 15, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 4, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 29, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REK Norway: 171640

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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Conditions

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