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Evaluating the Impact of COVID-19 (Coronavirus) on Research in Care Homes

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ClinicalTrials.gov Identifier: NCT04716972
Recruitment Status : Recruiting
First Posted : January 20, 2021
Last Update Posted : January 6, 2022
Sponsor:
Information provided by (Responsible Party):
The Royal Wolverhampton Hospitals NHS Trust

Study Description
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Brief Summary:

During the COVID-19 (corona virus) pandemic the research arena has had to rapidly adapt and change in order to facilitate and deliver research. The UK (United Kingdom) government and Public Health England have stressed the importance of such research to find solutions to treating, preventing and stopping the spread of COVID-19. Due to national and international 'lock down restrictions' delivering research in care home settings has become even more challenging. The adaptations to conducting consultations have relied heavily on the use of technology, for example video calling, telephone, email, and teleconferencing. It is suggested that the use of technology in care home settings is already a barrier to effective research delivery.

Nevertheless, as care home residents are a vulnerable group, it is critical to include these groups in research in order to enable improved and evidence-based care and their access to new and emerging treatments.

This study aims to assess the opinions and experiences of key stakeholders to identify barriers, and enable better facilitation of research in these settings during and post pandemic.


Condition or disease Intervention/treatment
Covid19 Other: survey Other: Interview

Detailed Description:

This two phase project will use a mixed methodology.

Phase one will involve mixed methods surveys. One will be completed by care home residents and the other will be completed by research delivery staff and care home staff.

Phase two will involve qualitative interviews with each of these groups to enable better insight into their views and opinions on research in this area.

Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluating the Impact of COVID-19 on Research in Care Homes
Actual Study Start Date : April 14, 2021
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Online Survey
Online survey
 Other: survey
Online survey
Interviews
Interviews
 Other: Interview
Interview


Outcome Measures
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Primary Outcome Measures :
  1. Acceptability of vaccine studies in the care home setting through feedback questionnaire with loose themes and no unique measurements. [ Time Frame: 6 months ]
    To inform the design and delivery of vaccine studies in the care home setting, ensuring they are acceptable by key stakeholders

  2. Acceptability of vaccine studies in the care home setting through feedback interview with loose themes and no unique measurements [ Time Frame: 6 months ]
    To inform the design and delivery of vaccine studies in the care home setting, ensuring they are acceptable by key stakeholders

  3. Acceptability of new ways of delivering research through explorative interview with loose themes and no unique measurements [ Time Frame: 6 months ]
    To inform and assess the acceptability of new ways of delivering research in care home settings, guiding changes and implementation of new ways of working moving forward

  4. Acceptability of new ways of delivering research through explorative questionnaire with loose themes and no unique measurements [ Time Frame: 6 months ]
    To inform and assess the acceptability of new ways of delivering research in care home settings, guiding changes and implementation of new ways of working moving forward


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Any staff member working/volunteering in a care home, research staff, residents of care homes, relatives of care home residents, all across the West Midlands are eligible to take part in this research project.
Criteria

Inclusion Criteria:

  • Any resident of a care home in the West Midlands
  • Any relative/friend of a care home resident in the West Midlands
  • Any staff member or volunteer working in care home in the West Midlands
  • Any researcher undertaking research in a care home in the West Midlands (during the pandemic or proposed during the pandemic period)

Exclusion Criteria:

  • Individuals who are unable to give Informed Consent
  • Individuals who lack capacity
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04716972


Contacts
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Contact: Kelly Hard 01743 261000 ext 1646 kelly.hard@nihr.ac.uk
Contact: Kelly Hard kelly.hard@nihr.ac.uk

Locations
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United Kingdom
The Royal Wolverhampton NHS Trust Recruiting
Wolverhampton, United Kingdom
Contact: Kelly Hard         
Principal Investigator: Kelly Hard         
Sponsors and Collaborators
The Royal Wolverhampton Hospitals NHS Trust
Investigators
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Principal Investigator: Kelly Hard National Institute for Health Research, United Kingdom
More Information
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Responsible Party: The Royal Wolverhampton Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT04716972    
Other Study ID Numbers: 2021COV114
First Posted: January 20, 2021    Key Record Dates
Last Update Posted: January 6, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases