Clinical trial NCT04740372: Development of an International COVID-19 Specific Quality of Life Questionnaire, Phase III. The OSLO COVID-19 QLQ
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19, Patient Reported Outcome Measures, Quality of Life
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: European Organisation for Research and Treatment of Cancer - EORTC
name: Medical University Innsbruck
name: Johannes Gutenberg University Mainz
name: Servicio de Navarro de Salud
name: University of Southampton
name: Skane University Hospital
name: Haukeland University Hospital
name: University of the East Ramon Magsaysay Memorial Medical Center
name: Sumandeep Vidyapeeth
name: Birzeit University
name: National Centre for Infectious Diseases
name: Komfo Anokye Teaching Hospital
First posted: 2021-02-05
Enrollment: 371
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
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.

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.

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

Eligibility 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

Primary outcomes:
measure: Validated COVID-19 specific questionnaire
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
References:
citation: Amdal CD, Falk RS, Singer S, Pe M, Piccinin C, Bottomley A, Appiah LT, Arraras JI, Bayer O, Buanes EA, Darlington AS, Arbanas GD, Hofso K, Holzner B, Sahlstrand-Johnson P, Kulis D, Parmar G, Rmeileh NMEA, Schranz M, Sodergren S, Bjordal K. A multicenter international prospective study of the validity and reliability of a COVID-19-specific health-related quality of life questionnaire. Qual Life Res. 2023 Feb;32(2):447-459. doi: 10.1007/s11136-022-03272-2. Epub 2022 Oct 23.