COVID-19 (SARS-CoV-2 infection) Infections and Infestations
Conditions
Interventions
The CONTACT feasibility study (in preparation for large cluster randomised control trial) is a single-arm non-randomized trial, taking place across two care homes in West Yorkshire, with approximately
Sponsors
University of Leeds
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Resident, staff member or visitor at participating care home 2. Willing to take part, and wear contact tracing device during presence in care home
Exclusion criteria
Exclusion criteria: 1. Wearing a contact device would constitute a risk of harm 2. Aged under 16 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proof of feasibility for the main trial: 1. Ease of administering the devices to people living and working in the care home, as well as family caregivers, healthcare professionals and external visitors to the home, assessed using Likert scale on ease of use across participants at 2 months following contact tracing system activation 2. The feasibility of completing the associated paperwork, including the linkage of devices with individual identities for residents, staff and visitors, assessed using CRF compliance at 2 months following system activation 3. The acceptability of wearing the devices and reasons for non-wear, assessed by completion of CRFs linked to device allocation and percentage of active devices at 2 months following system activation 4. Loss/breakage/replacement requirements in a 1-month period assessed by completion of CRFs linked to device allocation at 2 months following system activation 5. The feasibility of proposed methods of CONTACT tracing feedback assessed by qualitative feedback/interview at 2 months following system activation 6. Barriers to being a study champion in the sites assessed using qualitative interviews at 2 months following system activation 7. The feasibility of conducting phone calls to intervention homes assessed using contact history and determination of success at 2 months following system activation 8. Data transmission software (transfer-reading of data at trials unit; storage; analysis) assessed using manual verification with device allocation CRFs during the active study period 9. The feasibility of collecting the primary outcome data for the definitive study assessed using compliance reporting of data capture methods at 2 months following system activation | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures | — |
Countries
England, United Kingdom
Outcome results
None listed