Plain English Summary
Background and study aims
Alzheimer‘s disease (AD) is a common cause of dementia. People with dementia have difficulties with mental processes such as memory, language, reasoning and identifying people and objects, which become progressively worse over time as they age. Recently, there have been failures in developing medications to try and cure AD. This means new efforts are needed to support those suffering without the hope of a cure. New projects are being undertaken that are focused on aiding studies of new AD treatments. While these research goals are important, they are part of a strategy that will not impact patients for over 15 years. The aim of this study is to explore how the information collected at Memory Assessment Services when patients are referred and diagnosed with AD and/or dementia and additional information collected from patients and their study partners over a one year follow-up period could be used to improve patient treatment and care.
Who can participate?
Adults over the age of 18 who are referred to a Memory Assessment Service and their partner, family member or close friend.
What does the study involve?
Participants are visited in their own homes (or in a clinic if they prefer) where they are asked a series of questionnaires about living with dementia. Participants are either patients who have been referred to memory assessment services or study partners who are those who have consented to support the patient through the study and are happy to answer a set of questionnaires aimed at carers of people living with dementia. This takes place every three months for one year. Participants are also asked if they would like to use a wearable device that collects data about activity and sleep over two or 12 weeks (depending on the device they use).
What are the possible benefits and risks of participating?
There are no notable benefits or risks with participating.
Where is the study run from?
This study is being run from the University of Manchester (UK) and takes place in NHS Mental Health Trusts across England (UK).
When is the study starting and how long is it expected to run for?
April 2016 to March 2018
Who is funding the study?
Innovate UK (UK)
Who is the main contact?
1. Ms Francine Jury (Public)
francine.jury@manchester.ac.uk
2. Professor Derek Hill (Scientific)
Trial website
Contact information
Type
Public
Primary contact
Ms Francine Jury
ORCID ID
Contact details
Room 3.306
Jean McFarlane Building
University of Manchester
Oxford Road
Manchester
M13 9PY
United Kingdom
+44 161 306 7491
francine.jury@manchester.ac.uk
Type
Scientific
Additional contact
Prof Derek Hill
ORCID ID
Contact details
Ixico PLC
4th Floor
Griffin Court
15 Long Lane
London
EC1A 9PN
United Kingdom
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
30502
Study information
Scientific title
Project CYGNUS: A feasibility study of gathering health information in people with memory problems
Acronym
Study hypothesis
The aim of this study is to explore how the information collected at Memory Assessment Services at the point of referral and subsequent diagnosis and additional information collected from the cognitively impaired participants and their study partners over a one year follow-up period could be used to improve patient treatment and care.
Ethics approval
London – Central Research Ethics Committee, 23/04/2016, ref: 16/LO/0354
Study design
Observational; Design type: Cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Specialty: Dementias and neurodegeneration, Primary sub-specialty: Dementia; UKCRC code/ Disease: Neurological/ Other degenerative diseases of the nervous system
Intervention
Participants receive five home visits at three month intervals over 12 month periods. This involves being asked a series of questionnaires relating to outcomes for people living with dementia (the standard scales for dementia). The questions are answered by either the participant or by their study partners who have consented to support the participant through the study and are happy to answer a set of questionnaires aimed at carers of people living with dementia.
Participants are also asked if they would like to take part in a sub-study. This includes either using a wearable device to collect continuous data on activity and sleep over two or 12 weeks (depending on the device) or using mobile data collection which involves using a web/mobile app to collect self-reported data on a more regular basis from home (this is done weekly).
There are 2 wearable devices are:
The Withings device: This device is worn for 12 weeks and collects sleep and activity data. It is a commercial device which requires other technology to use such as a smartphone or tablet that can download an app to collect self-reported data on a more regular basis from home (this is done weekly).
The Axivity AX3 device: This device is worn for 2 weeks and does not required any other technology. It collects raw data over two weeks which is then downloaded.
The data collected is reviewed to examine the feasibility of collecting quality and actionable patient and carer reported outcomes.
Intervention type
Other
Phase
Drug names
Primary outcome measures
Information about Memory Assessment Services are measured using patient and carer reported outcomes (PRO) (Quality of Life, Activates of Daily Living, etc) at baseline, three, six, nine and twelve months.
Secondary outcome measures
Feasibility to collect quality and actionable patient and carer reported outcomes is measured using web-based and mobile technologies continuously or at weekly increments.
Overall trial start date
14/04/2016
Overall trial end date
31/03/2018
Reason abandoned
Eligibility
Participant inclusion criteria
Cognitively Impaired Participants:
1. Aged 18 years or older
2. Referred to a Memory Assessment Service with suspected Dementia by GP
3. Able to understand written and spoken English with the assistance of a carer/ study partner
4. Have capacity to consent
Study Partners:
1. Aged 18 years or older
2. Partner, Family Member or Close Friend is a participant in CYGNUS in the cognitively impaired participant group
3. English speaking/able to understand study documents
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 330; UK Sample Size: 330
Participant exclusion criteria
Cognitively Impaired Participants:
1. Aged younger than 18 years
2. Currently resident in a care or nursing home
3. Do not have capacity to consent
Study Partners:
1. Aged younger than 18 years
2. Do not have capacity to consent
3. Previously referred to memory assessment service themselves
Recruitment start date
01/04/2016
Recruitment end date
31/03/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Manchester
Room 3.306
Jean McFarlane Building
Oxford Road
Manchester
M13 9PY
United Kingdom
Sponsor information
Organisation
Ixico PLC
Sponsor details
4th Floor
Griffin Court
15 Long Lane
London
EC1A 9PN
United Kingdom
Sponsor type
Industry
Website
Funders
Funder type
Government
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
Planned publication in a high impact journal.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available due to the dataset is collected on a proprietary data platform at Ixico PLC and used for platform development. Paper based data collection could be made available on request from June 2018 but there would be a cost for retrieval for data archives.
Intention to publish date
31/05/2019
Participant level data
Not expected to be available
Results - basic reporting
Publication summary