Covid19, Patient Reported Outcome Measures, Quality of LifeNCT04740372
Development of an International COVID-19 Specific Quality of Life Questionnaire, Phase III. The OSLO COVID-19 QLQ
An observational study of Covid19, Patient Reported Outcome Measures, Quality of Life, run by Oslo University Hospital at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Patient Reported Outcome Measures, Quality of Life
- How many people
- 371 participants
- Where
- 1 siteNorway
- Study dates
- 20 Nov 2020to 15 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- No intervention. Method study. Psychometric testing
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention. Method study. Psychometric testingOther
Patients will fill in the questionnaire followed by an interview (phase IIIA) or a debriefing questionnaire (Phase IIIB)
What is being measured
The primary outcome is the main question the study is designed to answer.
Validated COVID-19 specific questionnaire
Instrument that can be used in international intervention and observational studies on patients with COVID-19 disease
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start20 Nov 2020
- Primary completion15 Jan 2022
- Study completion15 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19, Patient Reported Outcome Measures, Quality of LifeStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 371 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Cecilie Delphin Amdal, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04740372
- Sponsor's protocol ID
- REK Norway: 171640
- Status last verified
- Dec 2023
- First submitted
- 4 Feb 2021
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36273365
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04740372
- Acronym / sponsor ID
- REK Norway: 171640
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 371 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- 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
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 15 Jan 2022 (actual)
- Study completion
- 15 Sep 2022 (actual)
- First posted
- 5 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention. Method study. Psychometric testingPatients will fill in the questionnaire followed by an interview (phase IIIA) or a debriefing questionnaire (Phase IIIB) | Other | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Results publication: PubMed 36273365Amdal 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.
- The questionnaire is available at Mapi Research TrustLink provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, Patient Reported Outcome Measures, Quality of Life, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validated COVID-19 specific questionnaire (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04740372, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.