SENSE-Cog Residential Care: hearing and vision support for residents with dementia in long-term care in Ireland-protocol for a pilot cluster-randomised controlled trial.
J P Connelly, Erin Boland, Brenda Buckley, Niall Curley, Amr El Refaie, Miriam Galvin, Matthew Gibb, Liz Graham, Brendan Lennon, Alejandro Lopez Valdes, Ann-Michelle Mullally, Nicole Müller, Janice Nolan-Palmer, Gerald O' Nolan, Cíara O'Reilly, Valeria Raaft Rezk, Helen Rochford-Brennan, Katy Tobin, Helen Tormey, Dominic Trépel, Iracema Leroi
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引用次数: 0
Abstract
Background: Hearing and vision loss is highly prevalent in residents with dementia (RwD) living in long-term care (LTC) facilities. Sensory loss often has a negative impact on quality of life and other dementia-related outcomes. Optimising sensory function may improve dementia-related outcomes in LTC facilities. The SENSE-Cog Residential Care pilot trial will evaluate whether a multi-faceted hearing and vision intervention for RwD and concurrent sensory loss is suitable for definitive testing in a large-scale cluster-randomised control trial (RCT) in Ireland and how this can best be achieved.
Methods: This is a 6-month feasibility-pilot, multicentre, cluster RCT. Between eight and 15 LTC facilities (with an average of 5 RwD recruited per home) will be randomly assigned to receive either 'care as usual' (CAU) or a multi-component sensory intervention comprising (1) personalised resident hearing and vision support, (2) staff training in sensory health, (3) fostering a 'sensory friendly' environment, and (4) mapping sensory care provision with community-based audiologists and opticians. The intervention's feasibility, acceptability, and tolerability for residents and staff will be examined. In addition, a battery of exploratory outcome measures will be evaluated for suitability for the definitive trial and to inform the choice of primary and secondary outcome measures.
Discussion: If the SENSE-Cog Residential Care pilot trial demonstrates that the sensory support intervention for residential care is feasible and tolerated in LTC facilities in Ireland, a larger definitive trial to evaluate its effectiveness in improving dementia-related outcomes will be conducted. Training materials, resources, and information will be made available to health and social care providers to enable the implementation of sensory support for RwD in routine LTC, potentially improving the quality of such care in Ireland.
Trial registration: ISRCTN, ISRCTN14462472. Registered 24 February 2022, https://doi.org/10.1186/ISRCTN14462472.
期刊介绍：
Pilot and Feasibility Studies encompasses all aspects of the design, conduct and reporting of pilot and feasibility studies in biomedicine. The journal publishes research articles that are intended to directly influence future clinical trials or large scale observational studies, as well as protocols, commentaries and methodology articles. The journal also ensures that the results of all well-conducted, peer-reviewed, pilot and feasibility studies are published, regardless of outcome or significance of findings. Pilot and feasibility studies are increasingly conducted prior to a full randomized controlled trial. However, these studies often lack clear objectives, many remain unpublished, and there is confusion over the meanings of the words “pilot” and “feasibility”. Pilot and Feasibility Studies provides a forum for discussion around this key aspect of the scientific process, and seeks to ensure that these studies are published, so as to complete the publication thread for clinical research.
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