NCT04337788

Brief Summary

Since the last 3 months the world copes with the novel coronavirus disease : Covid-19 emerged in China in the end of 2019. WHO declared the pandemic situation as a Public Health Emergency around the world on January 2020. Firsts studies emphasized on higher risk to older adults to experience serious health consequences : hospitalizations and mortality, due to multimorbidity and multimedication. Nursing home resident are particulary frailer and vulnerable.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started May 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 3, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 8, 2020

Completed
23 days until next milestone

Study Start

First participant enrolled

May 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

June 9, 2026

Status Verified

April 1, 2026

Enrollment Period

2 months

First QC Date

April 3, 2020

Last Update Submit

June 5, 2026

Conditions

Keywords

Covid-19, early gerontologic healthcare

Outcome Measures

Primary Outcomes (1)

  • Impact of Gerontological telemonitoring on healthcare management for older adults living in Nursing Homes with symptoms of confirmed or probable COVID-19 disease (Death within 30 days).

    day 30

Study Arms (2)

gerontological telemonitoring action

EXPERIMENTAL

Nurses answer a daily resident-reported questionnaire (e.g. temperature, dyspnea, pain), edited by French health authorities. From D0 to D20, data are transmitted to the NHSP. Warning algorithms specially developed for older persons identify signs that are monitored by the NHSP geriatrician coordinator. A feedback is provided to the general physician for specific actions required and appropriate support. A last questionnaire is completed at D30 by the nurse in order to stop monitoring and know event occurred between D20 to D30.

Other: telehealth applications

routine care without gerontological telemonitoring

NO INTERVENTION

routine care

Interventions

telehealth applications during 30 days/patient

gerontological telemonitoring action

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Nursing home resident with Covid disease RT-PCR or Chest CT or rapid test
  • Nursing home resident with Covid-19 disease symptoms :
  • fever
  • cough
  • dyspnea
  • SPO2\<95% in ambient air (or \<91% in COPD patient)
  • Diarrhea
  • Fall or balance disorder
  • Confusion

You may not qualify if:

  • Age \< 75 years
  • Patient in respiratory distress
  • No consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Limoges

Limoges, 87042, France

Location

MeSH Terms

Conditions

Coronavirus InfectionsCOVID-19

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsPneumonia, ViralPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Prospective cohort study (here and elsewhere)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2020

First Posted

April 8, 2020

Study Start

May 1, 2020

Primary Completion

July 1, 2020

Study Completion

September 1, 2020

Last Updated

June 9, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations