NCT04642196

Brief 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 a fatal outcome, and a second aim is to assess the contribution of COVID-19 to those fatal outcomes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
155

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 2, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 22, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 24, 2020

Completed
Last Updated

November 24, 2020

Status Verified

November 1, 2020

Enrollment Period

5 months

First QC Date

November 22, 2020

Last Update Submit

November 23, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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)

    Up to one month before death

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult residents in home health care.

You may qualify if:

  • 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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of anesthesia

Linköping, 58185, Sweden

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

November 22, 2020

First Posted

November 24, 2020

Study Start

May 2, 2020

Primary Completion

October 10, 2020

Study Completion

October 10, 2020

Last Updated

November 24, 2020

Record last verified: 2020-11

Locations