A study of how stroke can impact how we think and feel in the long term. How common is it to have problems with processing information and feelings after stroke and what are the underlying causes?
| ISRCTN | ISRCTN81038194 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81038194 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 259478 |
| Protocol serial number | IRAS 259478 |
| Sponsor | University of Oxford |
| Funder | Stroke Association |
- Submission date
- 16/06/2021
- Registration date
- 16/06/2021
- Last edited
- 05/12/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
A stroke can affect the way your brain understands, organises, and stores information.
This project aims to determine the nature of cognitive problems at more than two years after stroke. We hope to gain understanding in how memory and thinking problems of varying severities impact on people’s daily life and recognize which information is important for identifying individuals who are at risk of developing declining cognition, such as dementia. In general, this study aims to improve how we look for and care for emotional, thinking and memory problems in long-term stroke survivors by assisting clinical teams, policy-makers, and future treatment research studies.
Who can participate?
Only individuals who have previously been recruited to the Oxford Cognitiive Screen Study can participate in this study.
What does the study involve?
The study involves participating in paper-based assessments that will be carried out remotely over the telephone – voice call or video call. Assessment packs will be participants, and the researcher will go through them with them during the pre-arranged telephone call appointment(s). Participants may be voice-recorded in order to facilitate scoring of certain tasks (for example naming and reading tasks, where more detailed scoring can take place if there are some problems with speech)
The first assessment period consists of a series of relatively short assessments that will be completed over multiple telephone call appointments, each lasting approximately 30 – 45 minutes (1 hour maximum) and up to a maximum of 4 hours in total.
The second assessment period will be carried out remotely over the telephone, in the same way as the first assessment period. This will be done one year after the first assessment period.
The study will involve a series of short questionnaires and tests that will assess functional abilities in activities of daily living, how the stroke impacted participants' quality of life, as well as language, memory, sight and problem-solving abilities. All of the questionnaires and assessments are relatively short, completed in a matter of minutes with opportunities for breaks at any time, if necessary.
We will also ask participants are happy to wear an activity tracker for a maximum of 1 week, which is completely optional. The sensor is the size of a watch and will be worn on the wrist to monitor physical activity. It records activity level continuously, such as movement/how many steps taken over a 7-day period, but it doesn’t track the type of activity. It records the amount of hours slept indirectly in the absence of movement for longer periods at night. The sensor does not record location (No GPS data). Monitors will be removed after 7 days and returned via a prepaid envelope.
In addition to phone assessments, we will look at participants' medical records to check information relevant to the study. We would also like to look at any brain scans that have been taken as part of routine care. All data collected will be de-identified and names will be kept separately from any research data.
What are the possible benefits and risks of participating?
There are no evident risks involved in carrying out the tests. Since the tests are simple paper-based assessments carried out remotely over the telephone, there is nothing invasive involved and therefore this research is low risk. If participants do experience any anxiety or distress during the assessment, they may stop at any time and/or pause to ask questions.
Where is the study run from?
University of Oxford (UK)
When is the study starting and how long is it expected to run for?
April 2019 to October 2022
Who is funding the study?
Stroke Association (UK)
Who is the main contact?
Prof Nele Demeyere, nele.demeyere@psy.ox.ac.uk
Contact information
Scientific
Cognitive Neuropsychology Centre
Department of Experimental Psychology
University of Oxford
Oxford
OX1 3UD
United Kingdom
 ORCID ID |
0000-0003-0416-5147 |
|---|---|
| Phone | +44 (0)1865 271 340 |
| nele.demeyere@psy.ox.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Single centre prospective cohort study |
| Secondary study design | Cohort study |
| Participant information sheet | ISRCTN81038194_PIS_v2_15Sep20.docx |
| Scientific title | Long term psychological consequences of stroke: prevalence, mechanisms, trajectories and impact |
| Study acronym | OX-CHRONIC |
| Study objectives | The aim of this project is to determine the prevalence, nature, trajectories and wider impact of cognitive impairment in long term stroke survivors, in relation with mood, fatigue, and quality of life. |
| Ethics approval(s) | Approved 08/11/2019, Health Research Authority, (Skipton House, 80 London Road, London, SE1 6LH, UK; +44 (0)20 7972 2545; hra.approval@nhs.net), ref: 19/SC/0530 |
| Health condition(s) or problem(s) studied | Prevalence of psychological consequences of stroke |
| Intervention | The purpose of the long-term follow-up assessments is to provide in-depth neuropsychological profiling using clinical screening tools in combination with more detailed cognitive testing batteries. Tests and questionnaires will be identical between both waves. Assessment tools were selected based on extensive use in research with stroke survivors in which acceptable levels of reliability and validity have been reported. Furthermore, the overall package of assessment tools was designed to limit the burden on participants. We achieved this by piloting assessments with stroke survivor representatives from our Study Management Team and Steering Committee. As a result, the test battery should provide in-depth assessments that will accurately capture the psychological consequences of stroke in a way that the results can be related back to existing literature. The study involves participating in paper-based assessments that will be carried out remotely over the telephone – voice call or video call. Assessment packs will be participants, and the researcher will go through them with them during the pre-arranged telephone call appointment(s). Participants may be voice-recorded in order to facilitate scoring of certain tasks (for example naming and reading tasks, where more detailed scoring can take place if there are some problems with speech) The first assessment period consists of a series of relatively short assessments that will be completed over multiple telephone call appointments, each lasting approximately 30 – 45 minutes (1 hour maximum) and up to a maximum of 4 hours in total. The second assessment period will be carried out remotely over the telephone, in the same way as the first assessment period. This will be done one year after the first assessment period. The study will involve a series of short questionnaires and tests that will assess functional abilities in activities of daily living, how the stroke impacted participants' quality of life, as well as language, memory, sight and problem-solving abilities. All of the questionnaires and assessments are relatively short, completed in a matter of minutes with opportunities for breaks at any time, if necessary. We will also ask participants are happy to wear an activity tracker for a maximum of 1 week, which is completely optional. The sensor is the size of a watch and will be worn on the wrist to monitor physical activity. It records activity level continuously, such as movement/how many steps taken over a 7-day period, but it doesn’t track the type of activity. It records the amount of hours slept indirectly in the absence of movement for longer periods at night. The sensor does not record location (No GPS data). Monitors will be removed after 7 days and returned via a prepaid envelope. In addition to phone assessments, we will look at participants' medical records to check information relevant to the study. We would also like to look at any brain scans that have been taken as part of routine care. All data collected will be de-identified and names will be kept separately from any research data. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Dementia status using DSM-5 criteria and based on medical records, cognitive testing and impairment in function of activities of daily living assessed by two trained physicians at wave 1 and wave 2 |
| Key secondary outcome measure(s) |
1. Language abilities measured using the Boston Naming Test at wave 1 and 2. |
| Completion date | 25/10/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 120 |
| Total final enrolment | 105 |
| Key inclusion criteria | OX-CHRONIC directly leverages existing data. A cognitive screening programme based within the acute stroke unit, capturing the Oxfordshire area has been ongoing since 2012. Participants in this study have been assessed for stroke specific cognitive impairments during acute recovery and at six-month follow-up. Participants agree to be followed up 6 months later with a home visit to assess psychological consequences of stroke and quality of life. Participants who completed the follow-up and gave explicit opt-in consent for re-contacting for further research will be contacted to take part in this two-year follow-up study. Importantly, there is a minimum two-year interval between stroke and the first new assessment for OX-CHRONIC. |
| Key exclusion criteria | 1. The participant is too unwell to be able to stay awake or concentrate for 30 minutes 2. The participant or consultee/proxy has insufficient English comprehension to complete assessments, |
| Date of first enrolment | 05/02/2020 |
| Date of final enrolment | 30/09/2022 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Experimental Psychology
Radcliffe Observatory Quarter
Oxford
OX2 6GG
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 30/11/2023 | 05/12/2023 | Yes | No | |
| Protocol article | 26/10/2021 | 28/03/2023 | Yes | No | |
| Dataset | OX-Chronic results dataset | 27/03/2023 | 28/03/2023 | No | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | version v2 | 15/09/2020 | 08/07/2021 | No | Yes |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- ISRCTN81038194_PIS_v2_15Sep20.docx
- Uploaded 08/07/2021
Editorial Notes
05/12/2023: The following changes have been made:
1. Publication reference and total final enrolment added.
2. Publication and dissemination plan updated.
28/03/2023: The following changes have been made and the plain English summary updated accordingly:
1. Publication reference and dataset added.
2. The overall end date was changed from 28/02/2023 to 25/10/2022.
27/09/2022: The overall end date was changed from 30/09/2022 to 28/02/2023.
08/07/2021: The participant information sheet has been uploaded.
16/06/2021: Trial's existence confirmed by the Stroke Association
