Covid19NCT04642196
COVID-19 in Home Healthcare
An observational study of Covid19, run by University Hospital, Linkoeping at 1 site in Sweden.
Trial summary
Assessment of cause of Death in home Healthcare residents in Östergötland County, Sweden, who had a positive COVID-19 diagnosis and died between March and September 2020. Our aim is to evaluate the pattern of comorbidity and frailty in a group of individuals in home healthcare with positive COVID-19 diagnoses who had… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Covid19
- How many people
- 155 participants
- Where
- 1 siteSweden
- Study dates
- 2 May 2020to 10 Oct 2020
- 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: Adult residents in home health care.
Who may be able to join
- adult (< 18 years) individuals and
- cared for in home healthcare in Östergötland county and
- positive COVID-19 diagnosis and
- diseased between March and September 2020
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COVID-19 in Home Healthcare and Mortality
Assessment of cause of Death in home Healthcare residents in Östergötland County, Sweden, who had a positive COVID-19 diagnosis and died between March and September 2020.
Our aim is to evaluate the pattern of comorbidity and frailty in a group of individuals in home healthcare with positive COVID-19 diagnoses who had a fatal outcome, and a second aim is to assess the contribution of COVID-19 to those fatal outcomes.
- Conditions
- Covid19
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Frailty
Frailty is classified i four groups:
- None or mild frailty: no restrictions in daily life.
- Moderate frailty: mobile and independent but unable to handle physically demanding activities or work.
- Considerable frailty: able to perform activities of daily living but confined at times to bed or chair.
- Severe frailty: unable to perform activities of daily living and/or confined to bed or chair. Dementia necessitating care.
Measured: Up to one month before death
Comorbidity
Comorbidity is classified in three Groups: none or mild comorbidity (0-1 diagnosis), moderate comorbidity (2 diagnoses), and severe comorbidity (3 or more diagnoses)
Measured: Up to one month before death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2020
- Study start2 May 2020
- Primary completion10 Oct 2020
- Study completion10 Oct 2020
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 Covid19Studies 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
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lena Nilsson, University Hospital, Linkoeping
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04642196
- Sponsor's protocol ID
- Home healthcare 2020
- Status last verified
- Nov 2020
- First submitted
- 22 Nov 2020
- Last updated
- 24 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nilsson L, Andersson C, Sjodahl R. COVID-19 as the sole cause of death is uncommon in frail home healthcare individuals: a population-based study. BMC Geriatr. 2021 Apr 20;21(1):262. doi: 10.1186/s12877-021-02176-z.
PubMed 33879078
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 in Home Healthcare and Mortality
- ClinicalTrials.gov ID
- NCT04642196
- Acronym / sponsor ID
- Home healthcare 2020
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Study start
- 2 May 2020 (actual)
- Primary completion
- 10 Oct 2020 (actual)
- Study completion
- 10 Oct 2020 (actual)
- First posted
- 24 Nov 2020 (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.
Assessment of cause of Death in home Healthcare residents in Östergötland County, Sweden, who had a positive COVID-19 diagnosis and died between March and September 2020.
Our aim is to evaluate the pattern of comorbidity and frailty in a group of individuals in home healthcare with positive COVID-19 diagnoses who had a fatal outcome, and a second aim is to assess the contribution of COVID-19 to those fatal outcomes.
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
- Adult residents in home health care.
Key inclusion criteria (4 listed)
- adult (< 18 years) individuals and
- cared for in home healthcare in Östergötland county and
- positive COVID-19 diagnosis and
- diseased between March and September 2020
Key exclusion criteria (1 listed)
- none
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
Frailty
Time frame: Up to one month before death
Frailty is classified i four groups: * None or mild frailty: no restrictions in daily life. * Moderate frailty: mobile and independent but unable to handle physically demanding activities or work. * Considerable frailty: able to perform activities of daily living but confined at times to bed or chair. * Severe frailty: unable to perform activities of daily living and/or confined to bed or chair. Dementia necessitating care.
Comorbidity
Time frame: Up to one month before death
Comorbidity is classified in three Groups: none or mild comorbidity (0-1 diagnosis), moderate comorbidity (2 diagnoses), and severe comorbidity (3 or more diagnoses)
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 24 Nov 2020.
- Derived from this study: PubMed 33879078Nilsson L, Andersson C, Sjodahl R. COVID-19 as the sole cause of death is uncommon in frail home healthcare individuals: a population-based study. BMC Geriatr. 2021 Apr 20;21(1):262. doi: 10.1186/s12877-021-02176-z.
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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 Covid19, run by University Hospital, Linkoeping 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 4 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 24 Nov 2020. 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?
Frailty (time frame: Up to one month before death). The study lists 2 primary outcomes in all. 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 NCT04642196, 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 24 Nov 2020.