The SENSE-Cog Randomised Controlled Trial (RCT): Comparing individualised sensory intervention to standard care to improve quality of life in people with dementia and their companions

• Register: ISRCTN
• Last refreshed on: 3 April 2023
• Main ID: ISRCTN17056211
• Date of registration: 19/02/2018
• Prospective Registration: Yes
• Primary sponsor: The University of Manchester
• Public title: The SENSE-Cog Randomised Controlled Trial (RCT): Comparing individualised sensory intervention to standard care to improve quality of life in people with dementia and their companions
• Scientific 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
• Date of first enrolment: 01/03/2018
• Target sample size: 708
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN17056211
• Study type: Interventional
• Study design: 36-week randomised controlled parallel-group observer-blind multicentre superiority trial (Quality of life)
• Phase: Not Applicable

Countries of recruitment

Cyprus, England, France, Greece, Ireland, United Kingdom

Contacts

• Name: Wai Yeung

• Name: Iracema Leroi

Key inclusion & exclusion criteria

Inclusion criteria:
Person with Dementia:
1. Aged = 60 years
2. Has received a clinical diagnosis of dementia as per NINCDS-ADRDA or ICD-10 criteria, of the following type: Alzheimer’s disease (AD), vascular dementia, or mixed AD and vascular dementia
3. Has mild to moderate stage of dementia as indicated by a Montreal Cognitive Assessment scale score =10 (MOCA; Nasreddine et al., 2005)
4. If taking cognitive enhancing medication (i.e. cholinesterase inhibitors or memantine), this must on a stable, unchanged dose for at least 4 weeks prior to screening
5. Has adult acquired hearing and/or vision impairment, defined by at least one of:
5.1. Vision impairment: defined by the presence of:
5.1.1. Binocular visual acuity = 6/9.5 and >6/60 in Snellen metric (or = +0.2 logMAR [75 EDTRS Score] and < +1.0 logMAR [35 EDTRS Score]) using the PEEK tool
5.1.2. Visual field > 10° using confrontation visual field tests
5.2. Hearing impairment: defined by symmetrical, mild to moderate, sloping high frequency sensorineural hearing loss of at least 40 dB at 2-6 kHz, with a score of 1 to 5 in each ear, using the HearCheck device
6. Living in an ordinary community dwelling (including sheltered and very sheltered accommodation)
7. Willing to accept SI
8. Has a companion who fulfils the criteria below and is willing to participate in the study
9. Has mental capacity to give informed consent to participate in the study or has a nominated consultee to provide consent on their behalf
10. Speaks and understands language of intervention delivery, as determined by the investigator;
11. Affiliated to a social security system (for France)

Companion:
1. Aged = 18 years
2. Informal caregiver (where providing care is not the person’s primary paid role), such as a significant other of the PwD (e.g. a family member or close friend), who is either co-resident or in regular contact (on at least a weekly basis)
3. Willing to participate in the study
4. Speaks and understands language of intervention delivery, as determined by the investigator
5. Affiliated to a social security system (for France)

Exclusion criteria:
Person with dementia:
1. Has an unstable, acute or current psychiatric or physical condition severe enough to prevent them from participating in the study, as determined by the investigator
2. Has complete blindness or severe visual impairment (category 2 & more on ICD-10 Version:2016) or deafness (profound hearing loss) to prevent them from following study procedures
3. Is currently participating in any other trial of a potentially cognitive enhancing intervention, excluding marketed cognitive enhancing medication
4. Has scheduled or urgent treatment or intervention for hearing or vision impairment (i.e. cataract operation already scheduled, treatment for macular degeneration needed)
5. Is unable to read and write

Companion:
1. Has an unstable, acute or current psychiatric or physical condition severe enough to prevent them from participating in the study, as determined by the investigator
2. Is unable to read and write

Note: The companion cannot participate if the person with dementia is ineligible or unwilling to participate.


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Dementia
Mental and Behavioural Disorders
Dementia

Intervention(s)

Participants are randomised on a 1-to 1 allocation to either the sensory intervention or care as usual group. This is done following completion of baseline assessment. Randomisation is stratified by centre, using permuted blocks of varying sizes. The block sizes are be disclosed to ensure allocation concealment. Full details of the randomisation scheme are included in a separate document with restricted access, kept by the independent statistician.

The Sensory Intervention (SI) is comprised of three parts, delivered over a period of up to 18 weeks:
1. Assessment of sensory impairment
2. Correction of sensory impairment
3. Maximum of ten Sensory Support Therapist home visits, typically on a weekly basis. A qualitative semi-structured interview areoffered to dyads who experienced the SI, at the end of the SI

The components of part three of the intervention are introduced one at a time on a weekly schedule in a flexible manner (over 10 weekly sessions maximum) to account for the extent to which a participant dyad requires a particular component, and their rate of progress with each component. Each dyad completes all the primary components of the SI, and whichever supportive and review components are agreed with the SST to meet their needs (see figure 2). These are accomplished through one visit from the SST per week, on average (some deviation will be allowed to account for personal circumstances, such as hospitalisation i.e. needing to do a catch-up visit for having a missed a week). In many cases, the work on one component overlaps with the initiation of another component, and will complement each other. Some components may require more time from the SST than others, e.g. o

Primary Outcome(s)

Quality of life in PwD with hearing and or visual impairment is measured using the self-rated DEMQOL at 36 weeks

Secondary Outcome(s)

For the person with dementia:
1. Quality of life is measured using
1.1. DEMQOL proxy at 18 weeks and 36 weeks
1.2. DEMQOL self-rated in PwD at 18 weeks
2. Functional ability (activities of daily living) are measured at 18 weeks
2.1. Dementia-related functional ability is measured using Bristol Activities of Daily Living (BADL)
2.2. Vision-related functional ability is measured using Veterans Affairs Low Vision –Visual Functioning Questionnaire (LV-VFQ-12) (self-report and proxy)
2.3. Hearing-related functional ability is measured using Hearing Handicap Inventory for the Elderly -Spouse (HHIE-S) (self-report and proxy)
2.4. Global cognitive functioning is measured using MOntreal Cognitive Assessment (MOCA)
3. Mental well-being is measured at 18 weeks:
3.1. Behaviour and psychological symptoms of dementia is measured using Neuro Psychiatric Inventory (NPI)-12
3.2. Relationships with companions are measured using Relationship Satisfaction Scale (RSS)

For the companion:
1. Mental wellbeing and quality of life are measured using General Health Questionnaire (QHS)-12 at weeks 18 and 36
2. General mental and emotional health is measured using 12 item Short Form Survey (SF12) at weeks 18 and 36
3. Depression and anxiety are measured using Hospital Anxiety and Depression Scale (HADS) at weeks 18 and 36
4. Caregiving experience (relationships with the PwD) are measured using Family Caregiving Role (FCR) and Relationship Satisfaction Scale weeks 18 and 36

Secondary ID(s)

36992

Source(s) of Monetary Support

European Commission

Ethics review

Status:
Approval date:
Contact:

North West -Haydock Research Ethics Committee, 12/02/2018, ref: 17/NW/0702

Results

• Results available: Yes
• Date Completed: 28/02/2022