Condition category
Mental and Behavioural Disorders
Date applied
08/10/2018
Date assigned
10/10/2018
Last edited
12/12/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Over 850,000 people living in the UK have been diagnosed with dementia. This number is expected to double over the next 20 years. People with dementia receive little routine monitoring by health care providers, with this responsibility falling to their family and friends. This means that, despite best efforts, there can be delays in picking up health issues such as urinary tract infections, falls or problems with mobility which may result in the person with dementia requiring more care from family and friends or being admitted to hospital. We have developed an Internet of Things (IoT) technologies system – using connected environmental sensors and healthcare devices – to monitor the person with dementia in their own home. This system is known as the TIHM for Dementia System of Care, and has been tested previously in a randomised controlled trial (ISRCTN46184518). Installed in the person with dementia’s home, it gathers information from the environment and connected healthcare devices (e.g. blood pressure monitor, weighing scales). This information is fed into a predictive algorithm which is designed to alert a team of clinicians monitoring the system 24 hours a day, seven days a week to any health issues the person with dementia may have. This team will then telephone the person with dementia or their carer to offer healthcare advice and support. This study aims to refine and evaluate the TIHM for Dementia System of care ready for wide use.

Who can participate?
People with dementia can participate along with their live-in or nominated carer if they are currently living in the community and receiving 10 or more hours per week of home care. Persons with dementia need to be aged 50 years or older and have a confirmed diagnosis of dementia (any type) and meet all other study inclusion criteria.

What does this study involve?
Participants will use the TIHM for Dementia System of Care for 6 months. This will involve the person with dementia being remotely-monitored in their home. Most of this monitoring will take place automatically, however the person with dementia and their carer may be asked to also take measurements, such as blood pressure, temperature and pulse. People with dementia and their nominated carers will be asked to complete some questionnaires at the beginning, middle (after 3 months) and end (at 6 months) of the study. They may also be invited to take part in an interview with a researcher about their experience of using the system; these will take place at the middle and end of the study. After using the TIHM for Dementia System of Care for 3 months and as a result of feedback from the questionnaires and interviews, the technologies installed in the person with dementia’s home may be reviewed and changed. Participants will then continue to use TIHM for Dementia for the remaining 3 months.

What are the possible benefits and risks of participating?
There is the opportunity to help improve current health care and support for people with dementia and their carers by helping to refine and evaluate a novel health monitoring and management system. Participants will also benefit from the additional continuous healthcare support the system provides.
Taking part in this study presents minimal risk; however, the TIHM for Dementia System of Care is an experimental system. People with dementia and their carers may find it intrusive to have sensors in their home and difficult or time-consuming to use devices. The system does not replace usual care and participants will be asked to contact their standard care provider (e.g. GP or A&E department) should they feel the need to do so.

Where is this study run from?
Six care commissioning groups (CCGs) in Surrey and North East Hampshire

When is the study starting and how long is it expected to run for?
July 2018 to July 2019

Who is funding the Study?
1. NHS England (UK)
2. Innovate UK (UK)

Who is the main contact?
Prof Emma Ream
e.ream@surrey.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Emma Ream

ORCID ID

http://orcid.org/0000-0001-5436-8036

Contact details

School of Health Sciences
Faculty of Health & Medical Sciences
University of Surrey
Guildford
GU2 7XH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

version 5

Study information

Scientific title

Technology Integrated Health Management (TIHM) for Dementia - Phase 1.5

Acronym

TIHM for Dementia 1.5

Study hypothesis

This study aims to refine and evaluate the TIHM for Dementia intervention (ISRCTN46184518) ready for implementation and scale-up.

Ethics approval

East of Scotland, 10/08/2018, ref: 18/ES/0075

Study design

Single-arm mixed-method adaptive observational cohort study with embedded process and cost evaluation

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Home

Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Dementia

Intervention

This study uses the TIHM for Dementia System of Care, an Internet of Things (IoT) health monitoring and integrated management system. This system gathers information about the person with dementia through environmental sensors installed in their home and devices which monitor their daily activity and vital signs (e.g. GPS tracker, blood pressure monitor, thermometer, weighing scales). The IoT relays this information to a dedicated monitoring team through a computer-based alert system, which uses machine learning algorithms to provide the team with actionable-information and alerts for health and social care concerns. The monitoring team then contacts the patient and/or their carer to offer advice. Dementia Navigators also provide support for non-emergency issues. Patients are monitored by the TIHM for Dementia system 24 hours a day, seven days a week for their six months of participation.

Intervention type

Device

Phase

Drug names

Primary outcome measure

The composition of an optimised TIHM for Dementia System of Care solution based on:
1. Direct cost: Data on service use and patterns of unpaid care and support provided by families and friends will be recorded by a modified version of the Client Service Receipt Inventory (CSRI). Costs will be attributed to service use using NHS reference costs and unit costs from the Personal Social Services Research Unit (PSSRU, www.pssru.ac.uk). This will be assessed at the baseline and after 3 and 6 months
2. Service-use data, collected via a modified CSRI at the baseline and after 3 and 6 months
3. System performance, captured in real-time through data captured by the system itself on alerts related to technical performance
4. User-acceptability, assessed using an investigator designed tool developed based on the TAM at the baseline and after 3 and 6 months

Secondary outcome measures

The following are assessed at the baseline and after 3 and 6 months:
1. Incidence of A&E attendance, assessed using a modified version of the Client Service Receipt Inventory (CSRI)
2. Duration of hospital stay, assessed using a modified version of the Client Service Receipt Inventory (CSRI)
3. Incidence and severity of neuropsychiatric symptoms experienced by the person with dementia (PwD), assessed using the Neuropsychiatric Inventory–Questionnaire (NPI)
4. Incidence of urinary tract infections, agitation and falls experience by the PwD, assessed using a modified version of the Client Service Receipt Inventory (CSRI)
5. Health Related Quality of Life (HR-QoL) of the PwD, assessed using:
5.1. DemQoL
5.2. EQ-5D-5L
6. HR-QoL of carers, assessed using the EQ-5D-5L
7. Carer burden, assessed using the Zarit Burden Interview
8. Technology acceptance, assessed using an investigator-developed tool

Overall trial start date

02/07/2018

Overall trial end date

30/09/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Person with dementia:
1. Male or female 50 years of age and older at baseline with a confirmed diagnosis of dementia (any type) by specialist assessment
2. Willing and able to provide informed consent
3. Standard MMSE score at baseline interview over 12
4. Living in the community
5. Receiving 10 or more hours per week of home care
6. Have a live in or nominated carer
7. Have sufficient functional English to allow completion of the assessment instruments
8. If on anti-dementia medication (cholinesterase inhibitors and/or memantine), on a stable dose for three months prior to recruitment

Carers of people with dementia:
1. Willing and able to provide informed consent
2. Single nominated informal carer (relative/friend) who has known the person with dementia for at least 6 months and is able to attend research assessments with the person with dementia
3. Have sufficient functional English to allow completion of the assessment instruments
4. Aged 18 or over

Professional (including health care, technology professionals) sample:
1. Aged 18 or over
2. Involved in the delivery of care/data monitoring/technical delivery of IoT intervention of people with dementia
3. Willing to provide informed consent

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

230 (100 people with dementia; 100 carers; 30 professionals)

Participant exclusion criteria

People with dementia:
1. In a residential care home
2. Receipt of any investigational drug within 30 days prior to consenting
3. People with unstable mental state including severe depression, severe psychosis, agitation and anxiety whom their medication was change over the last 4 weeks
4. People with severe sensory impairment
5. Unable to communicate verbally
6. Currently have active suicidal ideas
7. People who require regular elective hospital admission for their physical health monitoring
8. People who are receiving treatment for terminal illness

Carers of people with dementia:
1. Unable to communicate verbally

Professionals:
Does not meet inclusion criteria

Recruitment start date

20/08/2018

Recruitment end date

31/01/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Surrey and Borders Partnership NHS Foundation Trust
18 Mole Business Park Randalls Road
Leatherhead
KT22 7AD
United Kingdom

Sponsor information

Organisation

Surrey and Borders Partnership NHS Foundation Trust

Sponsor details

Abraham Cowley Unit
Holloway Hill
Chertsey
KT22 7AD
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

NHS England

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Innovate UK

Alternative name(s)

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

1. Planned publication in high-impact peer-reviewed journals
2. Dissemination at subject specific conferences
3. Research report for funders

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date

Intention to publish date

30/09/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

12/12/2018: The following changes have been made: 1. The recruitment date has been updated from 20/11/2018 to 31/01/2019. 2. The overall trial end date has been updated from 01/07/2019 to 30/09/2019. 3. The intention to publish has been updated from 30/11/2019 to 30/09/2020. 17/10/2018: References to ISRCTN46184518 have been added to the study hypothesis and plain English summary 12/10/2018: Internal review.