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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04740372
Recruitment Status : Recruiting
First Posted : February 5, 2021
Last Update Posted : February 5, 2021
Sponsor:
Collaborators:
European Organisation for Research and Treatment of Cancer - EORTC
Medical University Innsbruck
Johannes Gutenberg University Mainz
Servicio de Navarro de Salud
University of Southampton
Skane University Hospital
Haukeland University Hospital
University of the East Ramon Magsaysay Memorial Medical Center
Sumandeep Vidyapeeth
Birzeit University
National Centre for Infectious Diseases
Komfo Anokye Teaching Hospital
Information provided by (Responsible Party):
Cecilie Delphin Amdal, Oslo University Hospital

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment
Covid19, Patient Reported Outcome Measures, Quality of Life Other: No intervention. Method study. Psychometric testing

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 Design
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Study Type : Observational
Estimated Enrollment : 350 participants
Observational Model: Other
Time Perspective: Other
Official 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
Actual Study Start Date : November 20, 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Other: No intervention. Method study. Psychometric testing
    Patients will fill in the questionnaire followed by an interview (phase IIIA) or a debriefing questionnaire (Phase IIIB)

Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04740372


Contacts
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Contact: Cecilie D Amdal, PhD +4791517199 cecia@ous-hf.no
Contact: Kristin Bjordal, PhD kbj@ous-hf.no

Locations
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Norway
Oslo University Hospital Recruiting
Oslo, Norway, N-0424
Contact: Cecilie D Amdal, PhD    +4791517199    cecia@ous-hf.no   
Sponsors and Collaborators
Oslo University Hospital
European Organisation for Research and Treatment of Cancer - EORTC
Medical University Innsbruck
Johannes Gutenberg University Mainz
Servicio de Navarro de Salud
University of Southampton
Skane University Hospital
Haukeland University Hospital
University of the East Ramon Magsaysay Memorial Medical Center
Sumandeep Vidyapeeth
Birzeit University
National Centre for Infectious Diseases
Komfo Anokye Teaching Hospital
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Cecilie Delphin Amdal, Head of PROMiNET, Research support service, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT04740372    
Other Study ID Numbers: REK Norway: 171640
First Posted: February 5, 2021    Key Record Dates
Last Update Posted: February 5, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases