Covid19WW2COVID-19NCT04481477
Results of Emotional Support Activities During Hospital Admission With a Diagnosis of COVID19
An observational study of Covid19, run by Corporacion Parc Tauli at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Nursing care to reduce anxiety, fear and loneliness
- How many people
- 450 participants
- Where
- 1 siteSpain
- Study dates
- 27 Nov 2020to 15 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Residents in the CCSPT reference area
Who may be able to join
- 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
Who cannot join
- Communication problems or inability to read and speak Spanish
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
CorporacionPT
Sabadell, Barcelona, 08208
Montserrat Montaña, PhD, +34692617376, mmontana@tauli.cat
Jordi Torralbas, MSc, +34937231010, jtorralbas@tauli.cat
About this study
Official title: 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.
Read the 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.
- Conditions
- Covid19
- Being tested
- Nursing care to reduce anxiety, fear and loneliness
- Keywords
- Nursing care, Anxiety, Loneliness, Fear, COVID-19
- Medical subject headings
- COVID-19, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nursing care to reduce anxiety, fear and lonelinessOther
Decreased anxiety Presence Emotional support Improved security Increasing coping capacity Presence Emotional support Facilitating visits
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Nursing care to reduce anxiety, fear and loneliness |
What is being measured
The primary outcome is the main question the study is designed to answer.
The adequacy of nursing care to the needs of the patient
kappa concordance rate between care provided and care needed
Measured: 6 months after care
Secondary outcomes (1)
Intervention effectiveness
comparison of the percentage of positive impacts according to Csq-8 between the two groups using the Chi-square test
Measured: 6 months after care
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start27 Nov 2020
- Primary completion15 Apr 2021 (estimated)
- Study completion15 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Montserrat Montaña, Corporacion Parc Tauli
- Investigators
- Montserrat Montaña, PhD, Principal investigator, Corporación Parc Taulí
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04481477
- Sponsor's protocol ID
- 2020664
- Acronym
- WW2COVID-19
- Status last verified
- Mar 2021
- First submitted
- 21 Jul 2020
- Last updated
- 25 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact on Patients of Nurses' Emotional Support Activities During Hospital Admission With a Diagnosis of COVID19
- ClinicalTrials.gov ID
- NCT04481477
- Acronym / sponsor ID
- WW2COVID-19 / 2020664
- Conditions
- Covid19
- Keywords
- Nursing care, Anxiety, Loneliness, Fear, COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- 27 Nov 2020 (actual)
- Primary completion
- 15 Apr 2021 (estimated)
- Study completion
- 15 Apr 2021 (estimated)
- First posted
- 22 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients COVID-19 | – | Other: Nursing care to reduce anxiety, fear and lonelinessPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Residents in the CCSPT reference area
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Communication problems or inability to read and speak Spanish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nursing care to reduce anxiety, fear and lonelinessDecreased anxiety Presence Emotional support Improved security Increasing coping capacity Presence Emotional support Facilitating visits | Other | Patients COVID-19 |
Primary outcome
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
1 secondary outcome
Intervention effectiveness
Time frame: 6 months after care
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Montserrat Montaña, PhD principal investigator
Corporación Parc Taulí
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Corporacion Parc Tauli at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Montserrat Montaña, PhD (+34692617376, mmontana@tauli.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The adequacy of nursing care to the needs of the patient (time frame: 6 months after care). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2021.