Individualised sensory intervention to improve quality of life in people with dementia and their companions (SENSE-Cog trial): study protocol for a randomised controlled trial

Abstract

BackgroundHearing and vision impairments are highly prevalent in people with dementia and may have a negative impact on quality of life and other dementia-related outcomes. Intervening to optimise sensory impairment and support sensory function may be a means of improving dementia-related outcomes. The SENSE-Cog trial will test whether a home-based multi-part sensory intervention is effective in improving quality of life and other key outcomes in people with dementia and hearing or vision problems (or both) and their companions.MethodsThis is an European, multi-centre, observer-blind, pragmatic, randomised controlled trial. Three hundred fifty four people with dementia and hearing or vision impairment (or both) and their companions will be randomly assigned to receive either “care as usual” or a multi-component sensory intervention including assessment and correction of hearing or vision impairments (or both), home-based (maximum 10 visits over 18 weeks), therapist-delivered sensory support (that is, adherence to devices; improving the sensory environment (that is, lighting), communication training, and sign-posting to other support agencies). Change from baseline to intervention end (18 weeks) and post-intervention (36 weeks) will be compared between the two arms in the following outcomes: quality of life (primary endpoint), sensory and cognitive functional ability, relationships, mental well-being, health resource utilisation and cost-effectiveness.DiscussionThis is one of two articles outlining the SENSE-Cog trial. Here, we describe the protocol for the effectiveness of the SENSE-Cog intervention. A parallel and complementary process evaluation will be described elsewhere. If the SENSE-Cog trial demonstrates that the sensory intervention improves outcomes in dementia, we will make a toolkit of training materials, resources and information available to health and social care providers to implement the intervention in routine practice. This will be a significant contribution to the therapeutic management of people with dementia and sensory impairment.Trial registrationISRCTN (Trial ID: ISRCTN17056211) on 19 February 2018.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2973-0) contains supplementary material, which is available to authorized users.

Impact of an intervention to support hearing and vision in dementia: The SENSE‐Cog Field Trial

“…In the first report, we detailed the feasibility of conducting such a study in this population, as well as the acceptability and tolerability of the intervention itself . Findings in that report have informed the design and conduct or a larger, follow‐on RCT . Here, our exploratory analysis has revealed that managing hearing and vision impairment in PwD has a positive impact on a number of outcomes, including QoL, self‐efficacy, and neuropsychiatric symptoms.…”

“…Outcomes were assessed 1 week after the final intervention visit, and in a purposive subset of 10 dyads (five dyads at each of sites M and N) semistructured interviews were conducted to explore how dyads received the intervention and perceived its effectiveness. The details of the qualitative methods applied, including the use and development the topic guide for the interviews, is outlined in detail in the published protocol …”

“Losing my glasses…losing my mind”: Perspectives on sensory impairment, loneliness, social isolation and dementia

“…While the key node of the SENSE‐Cog intervention is hearing and vision remediation, social isolation associated with the sensory‐cognitive deficits is also addressed by the SST through referrals to community‐based activities. While this study was designed to inform a subsequent definitive trial, nonetheless, a signal of effectiveness was demonstrated through an improvement in dementia‐related quality of life (QoL). Qualitative exploration following the intervention, revealed that participants were more socially engaged, less isolated, less dependent on their care partners, and had improved functional ability and communication.…”

“…Qualitative exploration following the intervention, revealed that participants were more socially engaged, less isolated, less dependent on their care partners, and had improved functional ability and communication. A definitive trial of the intervention is ongoing in five European countries …”

Feasibility of an Intervention to Support Hearing and Vision in Dementia: The SENSE‐Cog Field Trial

“…Our secondary aim was to explore a signal of clinical and cost effectiveness that we report elsewhere (in preparation). The results of this study have informed the design and conduct of a full‐scale randomized controlled trial (RCT) in five European sites (ISRCTN 17056211) …”