Project CYGNUS: A feasibility study of gathering health information in people with memory problems
| ISRCTN | ISRCTN25427954 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25427954 |
| Secondary identifying numbers | 30502 |
- Submission date
- 27/03/2017
- Registration date
- 19/04/2017
- Last edited
- 22/05/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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)
Contact information
Public
Room 3.306
Jean McFarlane Building
University of Manchester
Oxford Road
Manchester
M13 9PY
United Kingdom
| Phone | +44 161 306 7491 |
|---|---|
| francine.jury@manchester.ac.uk |
Scientific
Ixico PLC
4th Floor
Griffin Court
15 Long Lane
London
EC1A 9PN
United Kingdom
Study information
| Study design | Observational; Design type: Cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Project CYGNUS: A feasibility study of gathering health information in people with memory problems |
| Study objectives | 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(s) | London – Central Research Ethics Committee, 23/04/2016, ref: 16/LO/0354 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 14/04/2016 |
| Completion date | 31/03/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 330; UK Sample Size: 330 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/04/2016 |
| Date of final enrolment | 31/03/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Jean McFarlane Building
Oxford Road
Manchester
M13 9PY
United Kingdom
Sponsor information
Industry
4th Floor
Griffin Court
15 Long Lane
London
EC1A 9PN
United Kingdom
| Website | http://www.ixico.com |
|---|---|
"ROR" |
https://ror.org/00paezp73 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- innovateuk
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/05/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high impact journal. |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
22/05/2019: Internal review.
24/10/2017: The registration of this study was requested through the NIHR Portfolio. The trialist confirmed the recruitment start and end dates.
