Dementia Mental and Behavioural Disorders Dementia
Conditions
Interventions
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 c
Sponsors
The University of Manchester
Eligibility
Sex/Gender
All
Inclusion 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 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of life in PwD with hearing and or visual impairment is measured using the self-rated DEMQOL at 36 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Cyprus, England, France, Greece, Ireland, United Kingdom
Contacts
Public ContactWai Yeung
Outcome results
None listed