NCT04481477

Brief Summary

The aim of the study is to find out what care patients affected by anxiety, fear or loneliness have perceived and the perceived impact of this care. This knowledge will allow us to design measures aimed at improving nursing care of these aspects in the future.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

July 21, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 22, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

November 27, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2021

Completed
Last Updated

March 25, 2021

Status Verified

March 1, 2021

Enrollment Period

5 months

First QC Date

July 21, 2020

Last Update Submit

March 23, 2021

Conditions

Keywords

Nursing careAnxietyLonelinessFearCOVID-19

Outcome Measures

Primary Outcomes (1)

  • The adequacy of nursing care to the needs of the patient

    kappa concordance rate between care provided and care needed

    6 months after care

Secondary Outcomes (1)

  • Intervention effectiveness

    6 months after care

Study Arms (1)

Patients COVID-19

Patients over the age of 18 who were admitted with a diagnosis of COVID-19 to any CCSPT unit between March 13, 2020 and April 30, 2020 and were discharged with a recovery result

Other: Nursing care to reduce anxiety, fear and loneliness

Interventions

Decreased anxiety Presence Emotional support Improved security Increasing coping capacity Presence Emotional support Facilitating visits

Patients COVID-19

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Residents in the CCSPT reference area

You may qualify if:

  • Patients over the age of 18 who were admitted with a diagnosis of COVID-19 to any CCSPT unit between March 13, 2020 and April 30, 2020 and were discharged with a recovery result

You may not qualify if:

  • Communication problems or inability to read and speak Spanish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CorporacionPT

Sabadell, Barcelona, 08208, Spain

RECRUITING

MeSH Terms

Conditions

COVID-19Anxiety Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

  • Montserrat Montaña, PhD

    Corporación Parc Taulí

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Montserrat Montaña, PhD

CONTACT

Jordi Torralbas, MSc

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Clinical Research

Study Record Dates

First Submitted

July 21, 2020

First Posted

July 22, 2020

Study Start

November 27, 2020

Primary Completion

April 15, 2021

Study Completion

April 15, 2021

Last Updated

March 25, 2021

Record last verified: 2021-03

Locations