Hearing and vision rehabilitation for people with dementia in five European countries (SENSE-Cog): a randomised controlled trial

Background: The effect of hearing and vision difficulties on the risk of developing dementia and worsening outcomes in people already living with dementia is well established. We evaluated the clinical impact of a hearing and vision rehabilitation and support programme on quality of life in people with mild-to-moderate dementia and concurrent sensory difficulties. Methods: We conducted a parallel-group, multicentre, observer-blind, superiority randomised controlled trial in seven older adult clinics in five European countries (Cyprus, France, Greece, Ireland, and the UK). People with mild-to-moderate dementia with adult-acquired hearing difficulties, vision difficulties, or both were randomly assigned (1:1) along with their care partner to an 18-week home-based sensory support intervention (SSI) of tailored hearing and vision rehabilitation and support, or to care as usual. Randomisation was blocked (block size of four, six, or eight) and stratified by country, with allocation assigned via a remote web-based system. The SSI included: full hearing assessment, vision assessment, or both; fitting of hearing aids, glasses, or other sensory aids; and home-based support from a sensory support therapist to assist adherence and uptake of sensory aids, foster social networking, and optimise the home sensory environment. Care as usual involved no additional intervention beyond services normally available to people with dementia at the respective sites. The primary outcome was health-related quality of life (Dementia Quality of Life Instrument [DEMQoL]) score at 36 weeks, reported as an adjusted mean difference. Analyses were done according to the intention-to-treat principle. This trial is registered with the ISRCTN Registry, ISRCTN17056211. Findings: Between May 4, 2018, and May 6, 2021, 252 people with mild-to-moderate dementia were randomly assigned, of whom 251 (n=126 in the SSI group and n=125 in the care as usual group) were included in the analysis. The mean age of participants was 79·6 years (SD 5·8), and 132 (53%) were women. After a median follow-up time of 37·7 weeks (IQR 36·2–39·0), the mean DEMQoL score was 92·8 (SD 15·2) in the SSI group and 92·8 (14·0) in the care as usual group (adjusted difference 0·18, 95% CI –2·13 to 2·30, p=0·87). Among 114 adverse events reported for 56 (44%) participants in the SSI group, ten events in nine participants were related or possibly related to the intervention (medical device pain or discomfort n=6, ear pain n=1, scratch to the ear n=1, sore eye n=1, redness n=1; all of grade 1). Serious adverse events were reported for 25 (20%) participants in the SSI group and 16 (13%) in the care as usual group. Six (5%) participants in the SSI group and five (4%) in the care as usual group died. None of the serious adverse events or deaths were related to the study intervention or procedures. Interpretation: This study showed no improvement in quality in life in participants who received the intervention in the longer term. Sensory difficulties are common in people with dementia and interventions aimed at improving sensory-cognitive health should be explored further.