SENSE-Cog Field Trial: Dementia and Sensory Impairment

SENSE-Cog Work Package 3.1 Field Trial Intervention Study: Testing the feasibility of a Sensory Support Intervention for people with dementia and sensory impairment

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN35019114

Enrollment

Registered

2018-01-16

Start date

2017-01-01

Completion date

Unknown

Last updated

2023-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia and hearing/vision impairment Nervous System Diseases Dementia and hearing/vision impairment

Interventions

The SENSE-Cog sensory support intervention (SSI) is a home-based individualised approach for PwD and sensory impairment and their study partners aimed at improving quality of life, reducing functional

(3) Communication training for the participant and their study partner (Component 3)

(4) Perform a home-based functional assessment with participants to identify skill areas in which they lack and wish to improve – this in turn leads to individualised goal setting with participants (C

(5) Participants are referred on to other services as appropriate which are beyond the remit of the SENSE-Cog study (e.g. psychological services, sensory support service)(Component 5)

(6) Signposting to environmental aids / devices in keeping with identified goals of participants – these are not provided to participants as part of the research study (Component 6). (

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Participants with dementia: 1. Age 60 years or older 2. Has a formal, clinical diagnosis of dementia of the following subtypes: Alzheimer’s disease (AD), as per National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDSADRDA) criteria35; vascular dementia (VaD) or mixed AD/VaD 3. Montreal Cognitive Assessment (MoCA)35 score of 12 or above 4. Adult acquired hearing and/or vision impairment 5. Hearing threshold >35 dB HL over 1–3 kHz and/or vision score of present binocular corrected visual acuity of =6/9, 5 Snellen metric or +0.2 LogMAR (75 Early Treatment Diabetic Retinopathy Study (ETDRS) Score) and/or visual field of 10–20° 6. Speaks and understands the language of the intervention delivery 7. Is willing to accept sensory support 8. Is living in an ordinary community dwelling (including sheltered and very sheltered accommodation) 9. Has a study partner willing to participate in the study (a family member or close friend who is either coresident or in regular contact (at least three times per week) 10. Has mental capacity sufficient to give informed consent to participate Study partner: 1. Age 18 years or older 2. Speaks and understands language of intervention delivery 3. Able to read and write 4. Not employed as a professional carer for the PwD, (except Nicosia, which may include professional, live-in carers) 5. Is a family member or a close friend who is either coresident or in regular contact (minimum of three times per week)

Exclusion criteria

Exclusion criteria: Participants with dementia: 1. Congenital hearing or vision impairment 2. Unstable, acute and current psychiatric or physical condition severe enough to prevent them from undertaking the study procedures 3. Has a less common form of dementia (eg, Parkinson's disease dementia, dementia with Lewy bodies, frontotemporal dementia) 4. Is currently participating in any other medication or non-medication related trial 5. Has urgent treatment scheduled for hearing or vision (eg, cataract operation, treatment for macular degeneration needed) Study partner: Has an unstable, acute and current psychiatric or physical condition severe enough to prevent them from participating.

Design outcomes

Primary

Measure	Time frame
1. PwD effort in-house rating scale in PwD and SP diaries after follow up at 12 weeks 2. PwD fatigue dyad members assessed by in-house rating scale in PwD and SP diaries and semistructured interview after follow up at 12 weeks 3. PwD motivation assessed by in-house rating scale in PwD and SP diaries and semistructured interview after follow up at 12 weeks 4. PwD engagement assessed by in-house rating scale in PwD and SP diaries and semistructured interview after follow up at 12 weeks 5. PwD understanding assessed by in-house rating scale in PwD and SP diaries and semistructured interview after follow up at 12 weeks 6. Frequency/duration of SSI sessions assessed by In-house rating scale in PwD and SP diaries and semistructured interview after follow up at 12 weeks 7. SSI feasibility is assessed by completion rates/missing data at baseline and follow-up 8. SSI delivered as intendef is assessed by SST diary checklist after each visit and at follow-up 9. SSI received as intended is assessed by Records of contact between SST and recipient. This will include information on: number and duration of contact, sessions, method, referrals and protocol deviations assessed at each visit. PwD and SP will have their knowledge of the SSI components checked by the SST at each visit 10. SSI enacted as intended is assessed by SST, PwD, SP diaries and semistructured interview at each visit and follow up 11. Reach assessed by proportion of referred patients who enter the study at baseline 12. Recruitment assessed by number of patients approached versus number recruited at baseline 13. Retention assessed by number of participants withdrawing and reasons throughout and at follow up 14. Screening assessed by number of patients screened ‘suitable’ versus ‘unsuitable’ at baseline	—

Measure

Time frame

1. PwD effort in-house rating scale in PwD and SP diaries after follow up at 12 weeks 2. PwD fatigue dyad members assessed by in-house rating scale in PwD and SP diaries and semistructured interview after follow up at 12 weeks 3. PwD motivation assessed by in-house rating scale in PwD and SP diaries and semistructured interview after follow up at 12 weeks 4. PwD engagement assessed by in-house rating scale in PwD and SP diaries and semistructured interview after follow up at 12 weeks 5. PwD understanding assessed by in-house rating scale in PwD and SP diaries and semistructured interview after follow up at 12 weeks 6. Frequency/duration of SSI sessions assessed by In-house rating scale in PwD and SP diaries and semistructured interview after follow up at 12 weeks 7. SSI feasibility is assessed by completion rates/missing data at baseline and follow-up 8. SSI delivered as intendef is assessed by SST diary checklist after each visit and at follow-up 9. SSI received as intended is assessed by Records of contact between SST and recipient. This will include information on: number and duration of contact, sessions, method, referrals and protocol deviations assessed at each visit. PwD and SP will have their knowledge of the SSI components checked by the SST at each visit 10. SSI enacted as intended is assessed by SST, PwD, SP diaries and semistructured interview at each visit and follow up 11. Reach assessed by proportion of referred patients who enter the study at baseline 12. Recruitment assessed by number of patients approached versus number recruited at baseline 13. Retention assessed by number of participants withdrawing and reasons throughout and at follow up 14. Screening assessed by number of patients screened ‘suitable’ versus ‘unsuitable’ at baseline

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Secondary

Measure	Time frame
Initial impression of efficacy measured by the following scales all at baseline and follow up: PwD outcome: 1. Quality of life measured by Dementia Quality of Life, EuroQol 5 Dimensions 5 Levels, 12-Item Short Form Survey 2. Cognition measured by Neuropsychiatric Inventory 3. General mental well-being measured by Generalised Self-Efficacy Scale 4. Function measured by Bristol Activities of Daily Living Scale 5. Cognition measured by Montreal Cognitive Assessment Study Partner outcome 1. Quality of Life measured by Dementia Quality of Life Proxy, EuroQol 5 Dimensions 5 Levels Proxy, 12-Item Short Form Survey Proxy 2. Mental health measured by Geriatric Depression Scale 3. Burden and stress measured by Family Caregiving Role Scale 4. Healthcare resource use measured by Resource Utilisation in Dementia Lite PwD and Study Partner Outcome 1. Relationship measured by Relationship Satisfaction Scale 2. Initial SSI efficacy measured by Dementia Quality of Life and Dementia Quality of Life Proxy	—

Measure

Time frame

Initial impression of efficacy measured by the following scales all at baseline and follow up: PwD outcome: 1. Quality of life measured by Dementia Quality of Life, EuroQol 5 Dimensions 5 Levels, 12-Item Short Form Survey 2. Cognition measured by Neuropsychiatric Inventory 3. General mental well-being measured by Generalised Self-Efficacy Scale 4. Function measured by Bristol Activities of Daily Living Scale 5. Cognition measured by Montreal Cognitive Assessment Study Partner outcome 1. Quality of Life measured by Dementia Quality of Life Proxy, EuroQol 5 Dimensions 5 Levels Proxy, 12-Item Short Form Survey Proxy 2. Mental health measured by Geriatric Depression Scale 3. Burden and stress measured by Family Caregiving Role Scale 4. Healthcare resource use measured by Resource Utilisation in Dementia Lite PwD and Study Partner Outcome 1. Relationship measured by Relationship Satisfaction Scale 2. Initial SSI efficacy measured by Dementia Quality of Life and Dementia Quality of Life Proxy

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Countries

Cyprus, England, France, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026