A Europe-wide randomized controlled trial of hearing and vision rehabilitation in dementia: Results from the SENSE-Cog trial

Background: Hearing and vision impairments are highly prevalent in people with dementia (PwD) and may have a negative impact on quality of life and other dementia-related outcomes. Intervening to optimize sensory function improve these outcomes. The SENSE-cog Trial evaluated whether a home-based multi-part ‘sensory support’ intervention (SSI) is effective in improving quality of life and other key outcomes in PwD (including hearing and/or vision problems), and their care partners. Methods: This was a pan-European, multi-centre, observer blind, randomized controlled trial (RCT), of PwD with hearing and/or vision impairment and their companions. We compared ‘care as usual’ (CAU) to a multi-part complex intervention of hearing and vision rehabilitation (SSI) tailored to each participant dyad. The SSI included: assessment and correction of hearing and/or vision impairments; home-based, therapist-delivered sensory support (i.e., adherence with devices; improving the sensory environment, communication training, and signposting to other support agencies). Outcomes were collected at baseline, intervention end (18 weeks) and post-intervention (36 weeks – the primary endpoint) and included: quality of life, sensory and cognitive functional ability, relationship satisfaction, neuropsychiatric symptoms, and mental well-being. Health resource utilization was measured to estimate cost-effectiveness of the intervention. Results: Across 7 European centers (UK, France, Cyprus, Greece), 252 participants with dementia (median age 80 years, 53% female, 59% hearing impairment only, 4% visual impairment only and 37% both impairments) were randomized from May 2018 to May 2021 to receive either CAU or SSI (10 visits over 18 weeks). Mitigating strategies to adapt study procedures to the COVID-19 pandemic were implemented. Over 75% of participants completed the primary outcome, the DEM-QoL scale, at 36 weeks. An initial feasibility study yielded positive results for this outcome revealing an average improvement in the DEM-QoL of 4.9 points (> minimum important clinical change). Conclusions: Hearing and vision support in PwD is a potentially important and cost-effective means of improving the lived experience of dementia, representing a critical step in the diagnostic and care pathway. Main RCT results will be available in May 2022. Trial registration: ISRCTN17056211.