Comorbidities and Coexisting ConditionsNCT04945863
COVID-19 in Nursing Homes 2020 and 2021
An observational study of Comorbidities and Coexisting Conditions and Frailty, run by Lena Nilsson at 1 site in Sweden.
Trial summary
To describe the effect on mortality in nursing home facilities during three separate equally long periods during the pandemic and more specifically to analyse the effect on mortality of improved preventive routines and vaccination. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Comorbidities and Coexisting Conditions, Frailty, Covid19
- How many people
- 258 participants
- Where
- 1 siteSweden
- Study dates
- 31 Mar 2020to 18 Apr 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Residents in nursing homes in Östergötland County Council, Sweden
Who may be able to join
- All residents in any of 136 nursing homes in Östergötland County Council, Sweden who had a laboratory confirmed COVID-19 diagnosis and who died within 30 days after the verified COVID-19 were included in three separate periods: First period from March 31 to June 30 2020; second period from October 15 2020 to January 15 2021; third period from January 16 to April 18 2021.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Anestesi- och operationskliniken, Universitetssjukhuset
Linköping, SE-581 85
About this study
Official title: Association Between COVID-19 Vaccination and Reduced Mortality in Nursing Home Facilities.
To describe the effect on mortality in nursing home facilities during three separate equally long periods during the pandemic and more specifically to analyse the effect on mortality of improved preventive routines and vaccination.
Read the detailed description
Retrospective descriptive cohort study in Östergötland County Council, Sweden comprising 136 nursing home facilities with a possibility to host 4500 residents. All residents in any of these NHs who had a laboratory confirmed COVID-19 diagnosis between March 2020 to April 2021 and who died within 30 days after the verified diagnosis are included. The study is undertaken as a retrospective record review. From the records patient-level data on demographic variables, clinical signs, comorbidity, performance status, and cause of death are collected.
- Conditions
- Comorbidities and Coexisting Conditions, Frailty, Covid19
- Medical subject headings
- Frailty, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Comorbidity
Number of diagnoses bedisde COVID-19
Measured: March 2020 to April 2021
Frailty
The combined assessment of performance status and frailty was adapted to the record review method
Measured: March 2020 to April 2021
Cause of death
assessment of cause of death
Measured: March 2020 to April 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2021
- Study start31 Mar 2020
- Primary completion18 Apr 2021
- Study completion18 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Comorbidities and Coexisting ConditionsStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 258 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lena Nilsson
- Sponsor type
- University, hospital or other
- Collaborators
- Region Östergötland
- Responsible party
- Sponsor-investigator, Lena Nilsson, University Hospital, Linkoeping
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04945863
- Sponsor's protocol ID
- NH COVID 19
- Status last verified
- Jun 2021
- First submitted
- 28 Jun 2021
- Last updated
- 7 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between COVID-19 Vaccination and Reduced Mortality in Nursing Home Facilities.
- ClinicalTrials.gov ID
- NCT04945863
- Acronym / sponsor ID
- NH COVID 19
- Conditions
- Comorbidities and Coexisting Conditions, Frailty, Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 258 participants (actual)
- Lead sponsor
- Lena NilssonUniversity, hospital or other
- Collaborators
- Region Östergötland
- Study start
- 31 Mar 2020 (actual)
- Primary completion
- 18 Apr 2021 (actual)
- Study completion
- 18 Apr 2021 (actual)
- First posted
- 30 Jun 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.
To describe the effect on mortality in nursing home facilities during three separate equally long periods during the pandemic and more specifically to analyse the effect on mortality of improved preventive routines and vaccination.
Detailed description
Retrospective descriptive cohort study in Östergötland County Council, Sweden comprising 136 nursing home facilities with a possibility to host 4500 residents. All residents in any of these NHs who had a laboratory confirmed COVID-19 diagnosis between March 2020 to April 2021 and who died within 30 days after the verified diagnosis are included. The study is undertaken as a retrospective record review. From the records patient-level data on demographic variables, clinical signs, comorbidity, performance status, and cause of death are collected.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Residents in nursing homes in Östergötland County Council, Sweden
Key inclusion criteria (1 listed)
- All residents in any of 136 nursing homes in Östergötland County Council, Sweden who had a laboratory confirmed COVID-19 diagnosis and who died within 30 days after the verified COVID-19 were included in three separate periods: First period from March 31 to June 30 2020; second period from October 15 2020 to January 15 2021; third period from January 16 to April 18 2021.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comorbidity
Time frame: March 2020 to April 2021
Number of diagnoses bedisde COVID-19
Frailty
Time frame: March 2020 to April 2021
The combined assessment of performance status and frailty was adapted to the record review method
Cause of death
Time frame: March 2020 to April 2021
assessment of cause of death
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 7 Jul 2021.
- Individual participant dataSharing planned: No
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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 Comorbidities and Coexisting Conditions and Frailty, run by Lena Nilsson at 1 site in Sweden.
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 1 inclusion and 1 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 7 Jul 2021. 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 Sweden. 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?
Comorbidity (time frame: March 2020 to April 2021). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jul 2021.