Plain English Summary
Background and study aims
Under-treated hearing and vision loss in the elderly costs the EU billions per year. The impact is significantly compounded by the presence of these impairments in people with dementia. To date, there have been almost no interventions to support vision and hearing impairment in people with dementia. The aim of the project is to develop, test and refine a newly developed 'sensory support' intervention for people with dementia and concurrent sensory impairment living at home. This will be undertaken using a mixed-methods approach, involving the integration of new information with existing evidence, experience and expertise.
Who can participate?
Adults aged 60 and older who have dementia and a family member or close friend.
What does the study involve?
Participants with dementia receive a sensory support intervention consisting of assessing their hearing/vision impairment, correcting hearing/vision impairment by receiving hearing aids/glasses where required and12 home visits by a sensory support therapist to assist participants with adapting to sensory equipment, promoting sensory conducive home environment, improving communication, and setting and obtaining goals. The person with dementia and sensory impairment and study partners are assessed before and after the sensory support for their quality of life, mental wellbeing, relationship satisfaction, activities of daily living, self-efficacy and cognition.
What are the possible benefits and risks of participating?
Direct benefits are free state of the art hearing aids and glasses, home based clinical assessment, support in own home for 12 weeks with a qualified therapists. Risks are minimal but may involve risk of falls with change in glasses. Steps to minimise this risk include therapist support and introduction of new lenses in a step-wise manner.
Where is the study run from?
University of Manchester (UK)
When is the study starting and how long is it expected to run for?
January 2016 to December 2017
Who is funding the study?
EU funder Horizon 2020 (EU)
Who is the main contact?
Dr Jemma Regan
jemma.regan@manchester.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Jemma Regan
ORCID ID
Contact details
Division of Neuroscience and Experimental Psychology
School of Biological Sciences
Faculty of Biology
Medicine and Health
University of Manchester
3.309 3rd Floor Jean McFarlane Building
Oxford Road
Manchester
M13 9PL
United Kingdom
+44 161 306 7957
jemma.regan@manchester.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1.0
Study information
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
Acronym
Study hypothesis
Can a new complex non-pharmacological individualised ‘sensory support’ intervention be developed to support people with dementia and concurrent sensory impairment living at home?
Ethics approval
North West - Preston Research Ethics Committee, 30/09/2016, ref: 212501
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.
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Home
Trial type
Quality of life
Patient information sheet
See additional files
Condition
Dementia and hearing/vision impairment
Intervention
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).
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
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 measures
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
Overall trial start date
01/01/2016
Overall trial end date
31/12/2017
Reason abandoned (if study stopped)
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
48 (24 people with dementia/24 companions)
Total final enrolment
38
Participant 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.
Recruitment start date
01/01/2017
Recruitment end date
30/09/2017
Locations
Countries of recruitment
Cyprus, France, United Kingdom
Trial participating centre
University of Manchester
Manchester
M13 9PL
United Kingdom
Trial participating centre
INSERM Université Victor Ségalen
-
France
Trial participating centre
Center for Applied Neuroscience, University of Cyprus
-
Cyprus
Sponsor information
Organisation
University of Manchester
Sponsor details
3.309 3rd Floor Jean McFarlane Building
Oxford Road
Manchester
M13 9PL
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Horizon 2020 Framework Programme
Alternative name(s)
EU Framework Programme for Research and Innovation H2020, Horizon 2020, Rahmenprogramm Horizont 2020, Programa Marco Horizonte 2020, Programme-cadre Horizon 2020, Programma quadro Orizzonte 2020, Program ramowy Horyzont 2020, H2020
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal. The protocol is published in BMJ Open.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Professor Iracema Leroi, Iracema.leroi@manchester.ac.uk
Intention to publish date
01/03/2018
Participant level data
Available on request
Basic results (scientific)
Publication list
2017 protocol in https://www.ncbi.nlm.nih.gov/pubmed/29187416
2019 results in https://www.ncbi.nlm.nih.gov/pubmed/31034588 (added 24/01/2020)
Publication citations
Additional files
- ISRCTN35019114_PIS_V.3.0_17Jan17_Partner.docx Uploaded 01/04/2019
- ISRCTN35019114_PIS_v3.0_ 17Jan17.docx Uploaded 01/04/2019