Covid19NCT04716972
Evaluating the Impact of COVID-19 (Coronavirus) on Research in Care Homes
An observational study of Covid19, run by The Royal Wolverhampton Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- survey and Interview
- How many people
- 7 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Apr 2021to 30 Jul 2022
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- Individuals who are unable to give Informed Consent
- Individuals who lack capacity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Covid19
- Being tested
- survey, Interview
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surveyOther
Online survey
InterviewOther
Interview
| Study group | Role | What they receive |
|---|---|---|
| Online Survey | Online survey Receives: Other: survey | |
| Interviews | Interviews Receives: Other: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of vaccine studies in the care home setting through feedback questionnaire with loose themes and no unique measurements.
To inform the design and delivery of vaccine studies in the care home setting, ensuring they are acceptable by key stakeholders
Measured: 6 months
Acceptability of vaccine studies in the care home setting through feedback interview with loose themes and no unique measurements
To inform the design and delivery of vaccine studies in the care home setting, ensuring they are acceptable by key stakeholders
Measured: 6 months
Acceptability of new ways of delivering research through explorative interview with loose themes and no unique measurements
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
Measured: 6 months
Acceptability of new ways of delivering research through explorative questionnaire with loose themes and no unique measurements
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start14 Apr 2021
- Primary completion30 Jul 2022
- Study completion30 Jul 2022
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Royal Wolverhampton Hospitals NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Kelly Hard, Principal investigator, National Institute for Health Research, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04716972
- Sponsor's protocol ID
- 2021COV114
- Status last verified
- Nov 2022
- First submitted
- 18 Jan 2021
- Last updated
- 10 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of COVID-19 on Research in Care Homes
- ClinicalTrials.gov ID
- NCT04716972
- Acronym / sponsor ID
- 2021COV114
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- The Royal Wolverhampton Hospitals NHS TrustOther government
- Study start
- 14 Apr 2021 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 20 Jan 2021 (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.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online Survey | – | Other: surveyOnline survey |
| Interviews | – | Other: InterviewInterviews |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (2 listed)
- Individuals who are unable to give Informed Consent
- Individuals who lack capacity
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 |
|---|---|---|
| surveyOnline survey | Other | Online Survey |
| InterviewInterview | Other | Interviews |
Primary outcome
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
- Individual participant dataSharing planned: No
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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.
Kelly Hard principal investigator
National Institute for Health Research, United Kingdom
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 The Royal Wolverhampton Hospitals NHS Trust at 1 site in United Kingdom.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 10 Nov 2022. 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of vaccine studies in the care home setting through feedback questionnaire with loose themes and no unique measurements. (time frame: 6 months). The study lists 4 primary outcomes in all. 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 10 Nov 2022.