NCT04740372

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 371 (actual)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Covid19, Patient Reported Outcome Measures, Quality of Life

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2020-11-20
• Primary completion: 2022-01-15
• Completion: 2022-09-15
• First posted: 2021-02-05
• Last updated: 2024-01-03

Locations

1 site across 1 country: Norway