The SENSE-Cog Randomised Controlled Trial: version 1
Research type
Research Study
Full title
SENSE-Cog Work Package 3.2: The SENSE-Cog trial: a 36-week randomised, controlled, parallel-group, observer-blind, multicentre superiority trial comparing individualised sensory support to standard care to improve quality of life in people with dementia and their companions
IRAS ID
213875
Contact name
Iracema Leroi
Contact email
Sponsor organisation
The University of Manchester
Duration of Study in the UK
2 years, 11 months, 31 days
Research summary
Summary of Research
The SENSE-Cog study aims to improve the quality of life of people with dementia (PWD) and their companions, by improving their hearing and vision and offering sensory support. Participants will be randomly allocated to receive either the sensory intervention (SI) or continue with their usual care. The SI is comprised of three parts, delivered up to 18 weeks: 1. Assessment of sensory impairment; 2. Correction of sensory impairment; 3. Maximum of ten SST home visits on a typically weekly basis working with a sensory support therapist (SST) up to 18 weeks in their own home. The outcomes of these two groups will be compared, to understand if the SI does improve quality of life.
Summary of Results
The SENSE-Cog trial is the first large-scale RCT to evaluate the effectiveness and cost-effectiveness of a multi-component hearing and vision rehabilitation intervention in people with dementia living in the community. The trial evaluated whether a home-based multi-part sensory intervention (SI), is effective in improving quality of life (QoL) and other key outcomes in people with dementia (PwD) and hearing and/or vision problems, and their care partners. This study adds to the growing body of literature of non-pharmacological interventions supporting quality of life in people living with a diagnosis of dementia.
The primary objective of the trial was to compare, at 36 weeks, the effect of the intervention versus usual care (CAU) on QoL in PwD with hearing and/or visual impairment. Secondary objectives for the PwD, were to compare, at W18 (+/-2 weeks) and W36 (+/-2 weeks), the effect of the intervention versus usual care on QoL, functional ability, global cognitive function and mental well-being. Additionally, for care partners we aimed to compare at 18 and 36 weeks, the effect of the intervention to CAU on mental well-being and relationship quality We screened 299 participant dyads (PwD and care partners). Of these, the number of eligible dyads randomised was 251. Fifty-nine dyads were lost to follow-up at week 36, an overall attrition rate of 23.5% (this was equivalent in both trial arms). This was slightly higher than that anticipated when calculating the original sample size (20%).
At baseline, the average age of PwD at baseline was around 80 years, with participant ages ranging from 60 to 93. Their Care Partners were, on average, younger, with an average age of around 65 years (range 30 to 97). There were slightly more female PwD (52.6%), although their Care Partners were much more likely to be female than male (by a ratio of almost 3 to 1). There was a gender imbalance between trial arms for both the PwD and their Care Partners (both >10%).
The vast majority of PwD had a hearing impairment (96.5%), either alone (59.8%) or in combination with a visual impairment. Fewer than 10 PwD had a visual impairment alone. Greater than 60% of PwD had received their diagnosis of dementia with the past two years, but a smaller number (10.1%) had been living with dementia for between four and ten years. Dementia severity varied from very mild (MOCA = 28) to very moderate (MOCA = 10), with the average MOCA score being 16.6. The vast majority had Alzheimer’s disease (64.9%), with a further 15.9% having vascular dementia and 19.1% have mixed dementia.
As expected, because of randomisation, most of the covariates presented below are very similar across the two trial arms. Notable exceptions are gender (both PwD and Care Partner), type of sensory impairment and dementia type. According to the Statistical Analysis Plan, such variables (gender of the Care Partner and dementia type) should be included, in addition to those that were pre-specified (age, gender and impairment of the PwD; location) in any regression models.
Primary outcome
Using various analyses, we compared the primary outcome (QoL in PwD at week 36), between the two arms of the study. The primary analysis controls for the DEMQoL score at baseline, the age of the PwD, their gender, the nature of their sensory impairment (vision, hearing or both), and country of residence (pre-specified covariates), plus, in addition, in a second model, the gender of the care partner and dementia type (which showed a clear difference between trial groups at baseline). Based on analysis, no significant difference in QoL between an individualised sensory support intervention and CAU at 36 weeks in people with dementia and hearing and/ or visual impairment was found. Thus, we do not reject the null hypothesis of no difference in quality of life between the two groups.REC name
North West - Haydock Research Ethics Committee
REC reference
17/NW/0702
Date of REC Opinion
21 Dec 2017
REC opinion
Favourable Opinion