- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04481477
Results of Emotional Support Activities During Hospital Admission With a Diagnosis of COVID19 (WW2COVID-19)
March 23, 2021 updated by: Montserrat Montaña, Corporacion Parc Tauli
Impact on Patients of Nurses' Emotional Support Activities During Hospital Admission With a Diagnosis of COVID19
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Anticipated)
450
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Montserrat Montaña, PhD
- Phone Number: +34692617376
- Email: mmontana@tauli.cat
Study Contact Backup
- Name: Jordi Torralbas, MSc
- Phone Number: +34937231010
- Email: jtorralbas@tauli.cat
Study Locations
-
-
Barcelona
-
Sabadell, Barcelona, Spain, 08208
- Recruiting
- CorporacionPT
-
Contact:
- Montserrat Montaña, PhD
- Phone Number: +34692617376
- Email: mmontana@tauli.cat
-
Contact:
- Jordi Torralbas, MSc
- Phone Number: +34937231010
- Email: jtorralbas@tauli.cat
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Residents in the CCSPT reference area
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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
|
Decreased anxiety Presence Emotional support Improved security Increasing coping capacity Presence Emotional support Facilitating visits
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The adequacy of nursing care to the needs of the patient
Time Frame: 6 months after care
|
kappa concordance rate between care provided and care needed
|
6 months after care
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intervention effectiveness
Time Frame: 6 months after care
|
comparison of the percentage of positive impacts according to Csq-8 between the two groups using the Chi-square test
|
6 months after care
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Montserrat Montaña, PHD, Corporacion Parc Tauli
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 27, 2020
Primary Completion (Anticipated)
April 15, 2021
Study Completion (Anticipated)
April 15, 2021
Study Registration Dates
First Submitted
July 21, 2020
First Submitted That Met QC Criteria
July 21, 2020
First Posted (Actual)
July 22, 2020
Study Record Updates
Last Update Posted (Actual)
March 25, 2021
Last Update Submitted That Met QC Criteria
March 23, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020664
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Covid19
-
Anavasi DiagnosticsNot yet recruiting
-
Ain Shams UniversityRecruiting
-
Israel Institute for Biological Research (IIBR)Completed
-
Colgate PalmoliveCompleted
-
Christian von BuchwaldCompleted
-
Luye Pharma Group Ltd.Shandong Boan Biotechnology Co., LtdActive, not recruiting
-
University of ZurichLabor Speiz; Swiss Armed Forces; Universitätsspital ZürichEnrolling by invitation
-
Alexandria UniversityCompleted
Clinical Trials on Nursing care to reduce anxiety, fear and loneliness
-
Corporacion Parc TauliUnknown
-
Bahcesehir Cyprus UniversityCompleted
-
Saglik Bilimleri Universitesi Gulhane Tip FakultesiCompletedChildbirth Fear, Anxiety,Birth PainTurkey
-
Universidad de AntioquiaRecruitingHypertensive Disorders of PregnancyColombia
-
University of Texas, El PasoUniversity of California, San Francisco; Centro de Integracion Juvenil; El Centro...Active, not recruiting
-
San Diego State UniversityKaiser Permanente; OCHIN, Inc.Not yet recruiting
-
University of California, San FranciscoNational Institute on Alcohol Abuse and Alcoholism (NIAAA)RecruitingLiver Diseases | Alcohol Use DisorderUnited States
-
St. John Health System, OklahomaUnknownMalnutrition | GastrostomyUnited States
-
Harvard UniversityCompletedDepression | Anxiety | Trauma | Behavior ProblemsUnited States
-
Harvard UniversityCompletedDepression | Anxiety | Trauma | Behavior ProblemsUnited States