NCT04716972

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 20, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

April 14, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2022

Completed
Last Updated

November 10, 2022

Status Verified

November 1, 2022

Enrollment Period

1.3 years

First QC Date

January 18, 2021

Last Update Submit

November 9, 2022

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

    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

    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

    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

    6 months

Study Arms (2)

Online Survey

Online survey

Other: survey

Interviews

Interviews

Other: Interview

Interventions

surveyOTHER

Online survey

Online Survey

Interview

Interviews

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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)

You may not qualify if:

  • Individuals who are unable to give Informed Consent
  • Individuals who lack capacity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Royal Wolverhampton NHS Trust

Wolverhampton, United Kingdom

Location

MeSH Terms

Conditions

COVID-19

Interventions

Surveys and QuestionnairesInterviews as Topic

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Kelly Hard

    National Institute for Health Research, United Kingdom

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2021

First Posted

January 20, 2021

Study Start

April 14, 2021

Primary Completion

July 30, 2022

Study Completion

July 30, 2022

Last Updated

November 10, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations