- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04716972
Evaluating the Impact of COVID-19 (Coronavirus) on Research in Care Homes
Evaluating the Impact of COVID-19 on Research in Care Homes
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.
Study Overview
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Wolverhampton, United Kingdom
- The Royal Wolverhampton NHS Trust
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Online Survey
Online survey
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Online survey
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Interviews
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Interview
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Acceptability of vaccine studies in the care home setting through feedback questionnaire with loose themes and no unique measurements.
Time Frame: 6 months
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To inform the design and delivery of vaccine studies in the care home setting, ensuring they are acceptable by key stakeholders
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6 months
|
|
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
|
6 months
|
|
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
|
6 months
|
|
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
|
6 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Kelly Hard, National Institute for Health Research, United Kingdom
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021COV114
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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