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      CONTACT: a non-randomised feasibility study of bluetooth-enabled wearables for contact tracing in UK care homes during the COVID-19 pandemic

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          Abstract

          Background

          The need for effective non-pharmaceutical infection prevention measures such as contact tracing in pandemics remains in care homes, but traditional approaches to contact tracing are not feasible in care homes. The CONTACT intervention introduces Bluetooth-enabled wearable devices (BLE wearables) as a potential solution for automated contact tracing. Using structured reports and reports triggered by positive COVID-19 cases in homes, we fed contact patterns and trends back to homes to support better-informed infection prevention decisions and reduce blanket application of restrictive measures. This paper reports on the evaluation of feasibility and acceptability of the intervention prior to a planned definitive cluster randomised trial of the CONTACT BLE wearable intervention.

          Methods

          CONTACT was a non-randomised mixed-method feasibility study over 2 months in four English care homes. Recruitment was via care home research networks, with individual consent. Data collection methods included routine data from the devices, case report forms, qualitative interviews (with staff and residents), field observation of care, and an adapted version of the NoMaD survey instrument to explore implementation using Normalisation Process Theory. Quantitative data were analysed using descriptive statistical methods. Qualitative data were thematically analysed using a framework approach and Normalisation Process Theory. Intervention and study delivery were evaluated against predefined progression criteria.

          Results

          Of 156 eligible residents, 105 agreed to wear a device, with 102 (97%) starting the intervention. Of 225 eligible staff, 82% ( n = 178) participated. Device loss and damage were significant: 11% of resident devices were lost or damaged, ~ 50% were replaced. Staff lost fewer devices, just 6%, but less than 10% were replaced. Fob wearables needed more battery changes than card-type devices (15% vs. 0%). Structured and reactive feedback was variably understood by homes but unlikely to be acted on. Researcher support for interpreting reports was valued. Homes found information useful when it confirmed rather than challenged preconceived contact patterns. Staff privacy concerns were a barrier to adoption. Study procedures added to existing work, making participation burdensome. Study participation benefits did not outweigh perceived burden and were amplified by the pandemic context. CONTACT did not meet its quantitative or qualitative progression criteria.

          Conclusion

          CONTACT found a large-scale definitive trial of BLE wearables for contact tracing and feedback-informed IPC in care homes unfeasible and unacceptable — at least in the context of shifting COVID-19 pandemic demands. Future research should co-design interventions and studies with care homes, focusing on successful intervention implementation as well as technical effectiveness.

          Trial registration

          ISRCTN registration: 11204126 registered 17/02/2021.

          Supplementary Information

          The online version contains supplementary material available at 10.1186/s40814-024-01549-6.

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          Most cited references34

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          A Behavioral Model of Rational Choice

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            Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact.

            This study proposes methods for blending design components of clinical effectiveness and implementation research. Such blending can provide benefits over pursuing these lines of research independently; for example, more rapid translational gains, more effective implementation strategies, and more useful information for decision makers. This study proposes a "hybrid effectiveness-implementation" typology, describes a rationale for their use, outlines the design decisions that must be faced, and provides several real-world examples. An effectiveness-implementation hybrid design is one that takes a dual focus a priori in assessing clinical effectiveness and implementation. We propose 3 hybrid types: (1) testing effects of a clinical intervention on relevant outcomes while observing and gathering information on implementation; (2) dual testing of clinical and implementation interventions/strategies; and (3) testing of an implementation strategy while observing and gathering information on the clinical intervention's impact on relevant outcomes. The hybrid typology proposed herein must be considered a construct still in evolution. Although traditional clinical effectiveness and implementation trials are likely to remain the most common approach to moving a clinical intervention through from efficacy research to public health impact, judicious use of the proposed hybrid designs could speed the translation of research findings into routine practice.
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              Sample size of 12 per group rule of thumb for a pilot study

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                Author and article information

                Contributors
                c.a.thompson@leeds.ac.uk
                Journal
                Pilot Feasibility Stud
                Pilot Feasibility Stud
                Pilot and Feasibility Studies
                BioMed Central (London )
                2055-5784
                2 October 2024
                2 October 2024
                2024
                : 10
                : 125
                Affiliations
                [1 ]School of Healthcare, University of Leeds, ( https://ror.org/024mrxd33) Baines Wing, Leeds, LS2 9JT UK
                [2 ]Leeds Institute of Clinical Trials Research, University of Leeds, ( https://ror.org/024mrxd33) Leeds, LS2 9JT UK
                [3 ]GRID grid.4868.2, ISNI 0000 0001 2171 1133, Academic Centre for Healthy Ageing, , Queen Mary University, ; London, E1 2AD UK
                [4 ]School of Civil Engineering, University of Leeds, ( https://ror.org/024mrxd33) Leeds, LS2 9JT UK
                [5 ]School of Electronics and Electrical Engineering, University of Leeds, ( https://ror.org/024mrxd33) LS2 9JT Leeds, UK
                [6 ]South Tyneside Council, South Shields, NE33 2RL UK
                [7 ]School of Medicine, Academic Unit of Health Economics, University of Leeds, ( https://ror.org/024mrxd33) Leeds, LS2 9JT UK
                Author information
                http://orcid.org/0000-0002-9369-1204
                Article
                1549
                10.1186/s40814-024-01549-6
                11445870
                39358817
                9c426c49-b137-4dc1-8462-121f2b5fb760
                © The Author(s) 2024

                Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.

                History
                : 8 August 2023
                : 20 September 2024
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/501100000664, Health Technology Assessment Programme;
                Award ID: NIHR132197
                Award Recipient :
                Categories
                Research
                Custom metadata
                © BioMed Central Ltd., part of Springer Nature 2024

                digital contact tracing,care homes,bluetooth-enabled wearables,long-term care,feasibility,covid-19,complex interventions

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