COVID-19 in Nursing Homes 2020 and 2021 | NCT04945863

Studies
COVID-19 in Nursing Homes 2020 and 2021

NCT04945863

Sponsor

Lena Nilsson

Status

Completed

Last Update Posted

Jul 7, 2021Actual

Enrollment

258Actual

Phase

Not provided

Conditions

Comorbidities and Coexisting Conditions
Frailty
Covid19

Interventions

Not provided

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 31, 2020Actual

Primary Completion Date

Apr 18, 2021Actual

Completion Date

Apr 18, 2021Actual

First Submitted Date

Jun 28, 2021

First Submission Date that Met QC Criteria

Jun 28, 2021

First Posted Date

Jun 30, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 30, 2021

Last Update Posted Date

Jul 7, 2021Actual

Name	Class
Region Östergötland	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

258Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Residents in nursing homes in Östergötland County Council, Sweden

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Anestesi- och operationskliniken, Universitetssjukhuset		Linköping		SE-581 85	Sweden

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000073496	Frailty
D000086382	COVID-19

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D011024	Pneumonia, Viral
D011014	Pneumonia

Browse Leaves

Not provided

Browse Branches

Not provided