Results of Emotional Support Activities During Hospital A... | NCT04481477

Studies
Results of Emotional Support Activities During Hospital Admission With a Diagnosis of COVID19

NCT04481477

Sponsor

Corporacion Parc Tauli

Status

Unknown status

Last Update Posted

Mar 25, 2021Actual

Enrollment

450Estimated

Phase

Not provided

Conditions

Covid19

Interventions

Nursing care to reduce anxiety, fear and loneliness

Countries

Spain

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

Mar 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 27, 2020Actual

Primary Completion Date

Apr 15, 2021Estimated

Completion Date

Apr 15, 2021Estimated

First Submitted Date

Jul 21, 2020

First Submission Date that Met QC Criteria

Jul 21, 2020

First Posted Date

Jul 22, 2020Actual

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

Mar 23, 2021

Last Update Posted Date

Mar 25, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Montserrat Montaña, Principal Investigator, Clinical Research, Corporacion Parc TauliPrincipal Investigator

Lead Sponsor

Corporacion Parc TauliOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

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.

Detailed Description

This is a cross-sectional descriptive study to be carried out at the Consorci Corporació Sanitària Parc Taulí (CCSPT). The results of this study will provide information on the care received by patients admitted to COVID 19 affected by anxiety, fear or loneliness, the perceived impact of this care and will enable measures to be implemented to improve nursing care in the future. 450 patients, randomly selected from the Hospital de Sabadell database, will be included. In the sample, we will ensure that the proportion of women and men is in line with the distribution of the population to enable the incorporation of the gender perspective in the analyses. The quantitative variables will be described by means of their mean and standard deviation. Qualitative variables will be described in absolute and relative frequencies. In order to evaluate the suitability of the intervention to the needs of the patient, a table of concordance will be constructed between the actions proposed by the panel of experts and the actions carried out as referred by the patient. The kappa concordance index will be calculated and the degree of concordance will be classified according to the Landis and Koch scale. As regards the effectiveness of the intervention, the patients who were treated correctly and those who were not will be identified, and the percentage of positive impacts according to Csq-8 between the two groups will be compared by means of the Chi-square test.

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

450Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Nursing care to reduce anxiety, fear and loneliness	Other	Decreased anxiety Presence Emotional support Improved security Increasing coping capacity Presence Emotional support Facilitating visits

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Intervention effectiveness	comparison of the percentage of positive impacts according to Csq-8 between the two groups using the Chi-square test	6 months after care

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Communication problems or inability to read and speak Spanish

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Residents in the CCSPT reference area

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Montserrat Montaña, PhD	Contact	+34692617376		mmontana@tauli.cat
Jordi Torralbas, MSc	Contact	+34937231010		jtorralbas@tauli.cat

Overall Officials

Name	Affiliation	Role
Montserrat Montaña, PhD	Corporación Parc Taulí	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CorporacionPT	Recruiting	Sabadell	Barcelona	08208	Spain

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19
D001008	Anxiety Disorders

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided