Thinking and memory changes in older people after emergency hospital treatment
| ISRCTN | ISRCTN24171810 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24171810 |
| IRAS number | 314002 |
| Secondary identifying numbers | CPMS 56808, IRAS 314002 |
- Submission date
- 04/08/2023
- Registration date
- 21/09/2023
- Last edited
- 16/06/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
The study aims to understand what causes new or worsened confusion (so-called delirium) in older people, on admission to hospital with an acute illness. We want to understand why some people get delirium in hospital but then recover well or which patients do not recover well from their illness and are at high risk of future problems with memory and thinking (cognitive impairment or dementia) over the next 3 years.
Who can participate?
Older people aged 70 years or above admitted to hospital or same day emergency care (Oxford University Hospitals or Royal Berkshire Foundation Trusts) with an acute illness
What does the study involve?
Collection of clinical information, cognition, frailty and mobility questionnaires and assessments, one blood sample (approx. 20 mls equivalent to 4 teaspoons) and CT brain imaging (OUHFT only) from participants and from their electronic health records while in hospital (baseline). Follow-up will be clinic visits (or home, virtually or by telephone as appropriate) at 3 months, I year and 3 years for one hour of further questionnaires and assessments of health status, cognition, frailty and mobility. There would be one further blood sample (20mls) taken at 3 months. An informant (family member or carer) will be identified while the participant is in hospital (someone who knows the participant for at least 10 years) to complete two short questionnaires (IQCODE and Neuropsychiatric Inventory) while the participant is in hospital and again at the 3 year visit.
What are the possible benefits and risks of participating?
The benefits for participants include: all study assessments will be added to their electronic health records which may help their direct clinical team with their care. The follow-up provides a health check that normal clinical care may not provide. Participants may gain benefit from participating in greater interaction with researchers and may find the research interesting. With participants permission results of the follow-up assessments may also be provided to their GP that may help with their clinical care. The study is deemed low risk and does not involve any kind of intervention that would carry significant risks to participants’ health. There may be a small risk of becoming anxious during assessments but the research team are experienced in recognising and lessening anxiety. There is the possibility of discomfort/bruising at the site where blood is taken.
Where is the study run from?
Wolfson Centre for Prevention of Stroke and Dementia, Nuffield Department of Clinical Neurosciences, University of Oxford (UK).
When is the study starting and how long is it expected to run for?
December 2021 to December 2027
Who is funding the study?
NIHR i4i programme grant (NIHR204290) and John Fell Fund, University of Oxford (No 0012734) (UK)
Who is the main contact?
Professor Sarah Pendlebury, sarah.pendlebury@ndcn.ox.ac.uk
Contact information
Principal Investigator
Wolfson Centre for Prevention of Stroke and Dementia
Nuffield Department of Clinical Neurosciences
University of Oxford
Wolfson Building
John Radcliffe Hospital
Headley Way
Oxford
OX3 9DU
United Kingdom
 ORCID ID |
0000-0003-3603-8388 |
|---|---|
| Phone | +44 1865 611267 |
| sarah.pendlebury@ouh.nhs.uk |
Study information
| Study design | Non-randomized observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Oxford and Reading cognitive health after recovery from acute illness and delirium-prospective study |
| Study acronym | ORCHARD-PS |
| Study objectives | The primary objective is to study multimodal biomarkers (clinical, cognitive, digital, blood, neuroimaging) associated with delirium and subsequent dementia in a consecutive cohort of older hospital patients. |
| Ethics approval(s) |
Approved 13/07/2023, South Central-Berkshire Research Ethics Committee (Health Research Authority, 2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 207 104 8233; berkshire.rec@hra.nhs.uk), ref: 23/SC/0199 |
| Health condition(s) or problem(s) studied | Delirium and dementia, acute hospital illness in older people (>70 years) |
| Intervention | After consenting the participant, the researcher will ask the research questions and administer the thinking and memory tests and mobility assessment. This should take not more than one hour but may need to be performed over more than one researcher visit if there are treatment requirements or the participant becomes fatigued. The researcher will liaise with the ward team to arrange for research bloods to be taken alongside the bloods required as part of routine care where possible. Clinical records would not be accessed by the research team until informed consent has been given. Additional information, including brain imaging from the patient's electronic record required for completion of the study research questions, will be extracted by the researcher at a convenient time after the patient interview has been completed. This will only be necessary for information recorded in free text form in the EPR since information recorded in categorical or numeric form will be available as part of the data fields in the Oxford Co-morbidity, Frailty and Ageing Research Database (ORCHARD). ORCHARD contains individual EPR data on all Oxford University Hospitals patients aged >/=70 years with unplanned admission and includes information on nursing risk assessments (eg falls risk, nutrition), observations, illness severity measures, diagnoses, and mandatory cognitive assessments. Before discharge, the researcher will arrange for a 3 month follow-up to be done in the out-patient clinic, in person at the patient's home or by telephone where this is not possible. Further follow-up visits will be planned for 1 and 3 years. At the follow-up visits, patients will be administered the study questions, and the thinking and memory tests and mobility assessments will be repeated. Research bloods will be repeated at the 3-month visit. If bloods are not done at 3-months, they can be done at a subsequent follow-up at year-one or year-three. |
| Intervention type | Other |
| Primary outcome measure | 1.1. Delirium subtype, duration and severity measured using 4AT (Rapid test for delirium), Memorial Delirium Assessment Scale (MDAS), Confusion Assessment Method (CAM), Abbreviated Mental Test Score (AMTS), Observational Study of Arousal (OSLA), Richmond Agitation Scale at baseline 1.2. Transient cognitive impairment measured using Abbreviated Mental Test Score (AMTS), Montreal Cognitive Assessment (MoCA) at baseline and 3 months 1.3. Dementia and dementia subtype diagnosis according to the DSM-5 criteria (major neurocognitive disorder) and accepted sub-type diagnostic criteria informed by clinical assessment including cognitive and functional assessments at 3 months, 1 and 3 years 2.1. Demographics (baseline only) and health factors collected using Electronic Patient Records (EPR) at baseline, 3 months, 1 and 3 years 2.2. Acute illness severity measured using EPR at baseline 2.3. Frailty measured using Rockwood Clinical Frailty Scale at baseline, 3 months, 1 and 3 years. 2.4. Multimorbidity defined by the Charlson index at baseline, 3 months, 1 and 3 years. 2.5. Cognitive profile-participant assessment (AMTS, MoCA, OCS-plus) collected at baseline, 3 months, 1 and 3 years. 2.6. Cognitive profile- Informant assessment (Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE), 10-point Neuropsychiatric Inventory ) at baseline and 3 years 3. Blood biomarkers collected at baseline and 3 months for inflammatory markers, neurodegeneration markers, genetic profile. 4. Brain imaging at baseline for global and regional atrophy, white matter changes defined using visual rating scales and semi-automated image analysis techniques. |
| Secondary outcome measures | 1.1. Outcome measured using length of stay, readmission within 30-days, and mortality from electronic records and European Quality of Life Score (Euroqol) at 3 months, 1 and 3 years 1.2. Function measured using Hospital Assessment of Balance and Mobility (HABAM), Nottingham Extended Activities of Daily Living (ADL), Timed Up and Go Test (TUG) and modified Rankin Scale (pre-morbid at baseline) at baseline, 3 months, 1 and 3 years 2. Added Value of advanced proton-counting CT brain imaging for quantifying brain atrophy and cerebrovascular disease including small vessel disease |
| Overall study start date | 01/12/2021 |
| Completion date | 31/12/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 70 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 550; UK Sample Size: 550 |
| Key inclusion criteria | 1. Adult hospital patients aged >=70 years with unplanned admission to OUHFT or RBHFT or assessed in the SDECs 2. Patient is willing and able to give informed consent for participation in the study OR Seek advice from a personal consultee (family member, friend or carer). If a personal consultee is unavailable, advice will be sought from a member of the hospital staff who is not part of the research team (professional consultee) |
| Key exclusion criteria | 1. Moribund status 2. Nursing Care home residence 3. Severe dementia with high degree of dependency e.g. bedbound |
| Date of first enrolment | 09/08/2023 |
| Date of final enrolment | 31/07/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
London Road
Reading
RG1 5AN
United Kingdom
Sponsor information
University/education
University Offices
Oxford
OX1 2JD
England
United Kingdom
| RGEA.Sponsor@admin.ox.ac.uk | |
| Website | http://www.ox.ac.uk/ |
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/12/2028 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository, Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. Dissemination is also planned for interested lay/public involvement groups. |
| IPD sharing plan | At the end of the study and when all results have been published the anonymised research data will be held in a secure repository for data sharing e.g. Dementia Platform UK in line with the University of Oxford and Funders Open data requirements. Data will be held according to the appropriate procedures and data sharing agreements in place and approved researchers may apply to access the data repository according to the agreed protocol. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 13/06/2025 | 16/06/2025 | Yes | No |
Editorial Notes
16/06/2025: Publication reference added.
20/02/2025: The recruitment end date was changed from 28/02/2025 to 31/07/2025. Study website added.
04/08/2023: Trial's existence confirmed by National Institute for Health and Care Research (NIHR) (UK).
