SENSE-Cog Field Trial: Dementia and Sensory Impairment

• Register: ISRCTN
• Last refreshed on: 6 March 2023
• Main ID: ISRCTN35019114
• Date of registration: 16/01/2018
• Prospective Registration: No
• Primary sponsor: University of Manchester
• Public title: SENSE-Cog Field Trial: Dementia and Sensory Impairment
• Scientific title: 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
• Date of first enrolment: 01/01/2017
• Target sample size: 48
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN35019114
• Study type: Interventional
• Study design: This is an open-label feasibility study in people with dementia and sensory impairments and their study partners (8 dyads in each of three clinical sites); there is no control group. (Quality of life)
• Phase: Not Applicable

Countries of recruitment

Cyprus, England, France, United Kingdom

Contacts

• Name: Jemma Regan

Key inclusion & exclusion 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:
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.


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

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

Intervention(s)

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 disability and increasing social connectedness. PwD and their study partners will work with a sensory support worker (SSW) in various domains over 12 weekly sessions (the number of sessions may vary from participant to participant but the maximum number of visits will be 12 at a rate of 1 per week) to:
(1) Identify and correct any vision or hearing impairment (Component 1)
(2) Support the impairment correction with on-going advice and training in correct use and care of provided devices (Component 2);
(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 (Component 4);
(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).
(7) Signposting to social engagement activities / support groups / special interest groups as appropriate for participant identified goals (Component 7).

Primary Outcome(s)

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
15. Assessment of impairment and corrective device delivery and fitting, assessed by SST, PwD, SP diaries; feedback from research team and industry partners at follow up
16. Functional assessments assessed by SST, PwD, SP diaries; analysis of frequency of missing data at follow up
17. ‘Logistics circuit’ of hearing/vision assessments and devices, assessed by SST, PwD, SP diaries; feedback from research team and industry partners at follow up
18. SST training assessed by SST diary will identify areas of training for the role at follow up
19. SST visits SST, Glasses usage, Hearing aid usage, Receptivity to sensory equipment, Helpfulness of SSI, Motivation to continue with SSI activities assessed by PwD, SP diaries; semistructured interview at follow up

Secondary Outcome(s)

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

Secondary ID(s)

1.0

Source(s) of Monetary Support

Horizon 2020 Framework Programme

Ethics review

Status:
Approval date:
Contact:

North West - Preston Research Ethics Committee, 30/09/2016, ref: 212501

Results

• Results available: Yes
• Date Completed: 31/12/2017