NCT04945863

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
258

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

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

March 31, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 30, 2021

Completed
Last Updated

July 7, 2021

Status Verified

June 1, 2021

Enrollment Period

1 year

First QC Date

June 28, 2021

Last Update Submit

June 30, 2021

Conditions

Comorbidities and Coexisting ConditionsFrailtyCovid19

Outcome Measures

Primary Outcomes (3)

  • Comorbidity

    Number of diagnoses bedisde COVID-19

    March 2020 to April 2021

  • Frailty

    The combined assessment of performance status and frailty was adapted to the record review method

    March 2020 to April 2021

  • Cause of death

    assessment of cause of death

    March 2020 to April 2021

Eligibility Criteria

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

Residents in nursing homes in Östergötland County Council, Sweden

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anestesi- och operationskliniken, Universitetssjukhuset

Linköping, SE-581 85, Sweden

Location

MeSH Terms

Conditions

FrailtyCOVID-19

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsPneumonia, 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
SPONSOR INVESTIGATOR
PI Title
MD, Associate Professor, Chief Medical Officer

Study Record Dates

First Submitted

June 28, 2021

First Posted

June 30, 2021

Study Start

March 31, 2020

Primary Completion

April 18, 2021

Study Completion

April 18, 2021

Last Updated

July 7, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)