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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04481477
Other study ID # 2020664
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 27, 2020
Est. completion date April 15, 2021

Study information

Verified date March 2021
Source Corporacion Parc Tauli
Contact Montserrat Montaña, PhD
Phone +34692617376
Email mmontana@tauli.cat
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 450
Est. completion date April 15, 2021
Est. primary completion date April 15, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Nursing care to reduce anxiety, fear and loneliness
Decreased anxiety Presence Emotional support Improved security Increasing coping capacity Presence Emotional support Facilitating visits

Locations

Country Name City State
Spain CorporacionPT Sabadell Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Corporacion Parc Tauli

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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