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

Covid19, Patient Reported Outcome Measures, Quality of Life Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04740372
• Other study ID #: REK Norway: 171640
• Status: Completed
• Start date: November 20, 2020
• Est. completion date: September 15, 2022

Study information

• Verified date: December 2023
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 371
• Est. completion date: September 15, 2022
• Est. primary completion date: January 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19, Patient Reported Outcome Measures, Quality of Life

Intervention

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)

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (13)

Lead Sponsor

Collaborator

Oslo University Hospital

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

Country where clinical trial is conducted

Norway, 

References & Publications (1)

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 i — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validated COVID-19 specific questionnaire	Instrument that can be used in international intervention and observational studies on patients with COVID-19 disease	6 months

External Links

•   The questionnaire is available at Mapi Research Trust