AnosognosiaNCT06940882
Development of a Novel Screening Tool for Anosognosia After Stroke.
An observational study of Anosognosia and Stroke, run by University of Exeter.
Trial summary
Anosognosia, a neurological inability to acknowledge or comprehend one's own (dis)abilities, is a multi-faceted phenomenon which has consistently gained traction in research fields spanning psychology, neurology, and cognition since its conceptual introduction in 1914. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anosognosia, Stroke
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Oct 2025to Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stroke patients admitted to a stroke rehabilitation ward. Multi-disciplinary staff working with stroke patients on a stroke rehabilitation ward.
Who may be able to join
- Patients aged 18 years or above who are admitted to the stroke rehabilitation unit with a clinical diagnosis of stroke.
- Multi-disciplinary staff working on the stroke rehabilitation unit.
Who cannot join
- Patients with a clinical diagnosis other than stroke.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Alexis Clarke, DClinPsy, QiCN contact
About this study
Official title: Development and Exploration of the Acceptability and Feasibility of a Novel Screening Tool for Anosognosia After Stroke, Designed for Routine Use in Hospital Settings.
Anosognosia, a neurological inability to acknowledge or comprehend one's own (dis)abilities, is a multi-faceted phenomenon which has consistently gained traction in research fields spanning psychology, neurology, and cognition since its conceptual introduction in 1914. Though anosognosia is not limited to following only neurological disease or injury, the majority of research has focused on the prevalence and mechanisms of anosognosia after stroke. Despite this, there is no clear consensus among the literature, and thus in clinical practice, as to how anosognosia after stroke should be assessed. This is startling given the plethora of studies which highlight anosognosia as a barrier to rehabilitation, a risk to safe discharge, and a predictor of poorer psychological and functional outcomes for both patients and their carers. Currently, there exists a vast number of assessment methods for anosognosia after stroke, which vary from performance- and observation-based tasks to self-report and discrepancy-based interviews; clinicians working in stroke make arbitrary choices as to which of these methods to use on a case-by-case basis, risking missed cases and subsequently noncomprehensive care. This research aims to develop a new screening tool for anosognosia that can be routinely implemented with post-stroke patients in hospital settings, to inform care, rehabilitation, and discharge. The study will explore the acceptability and feasibility of the new screening tool among multi-disciplinary staff working on a stroke rehabilitation unit, and provide grounds for future studies to assess the screen's psychometric properties and ability to inform novel interventions for anosognosia. Findings will have great implications for stroke survivors, their carers, and healthcare professionals alike.
- Conditions
- Anosognosia, Stroke
- Keywords
- Anosognosia, Stroke, Assessment
- Medical subject headings
- Agnosia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients admitted to a stroke rehabilitation unit following clinical diagnosis of stroke. Participation will involve completion of a new screening tool for anosognosia, to be administered by multi-disciplinary staff working on the stroke rehabilitation unit. | |
| Staff | Multi-disciplinary staff working on a stroke rehabilitation unit. Participation will involve administering a new screening tool for anosognosia with patients, and then attending focus groups to explore the acceptability and feasibility of the new screening tool among the staff group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability and Feasibility of new screening tool among multi-disciplinary staff
Focus groups will be conducted with staff who administer the new screening tool on the target stroke rehabilitation ward, to explore their views of and experiences with the tool. This will be in relation to the tool's content, structure, length, response/scoring formats, and administration demands.
Measured: From recruitment, throughout 4-6 months of screen implementation, to the completion of focus groups approximately 8 months after recruitment.
Secondary outcomes (1)
Uptake and Validity of new screening tool, with patients
Demographic data and stroke-related data (stroke location, severity) will provide descriptive insight into the usability of the tool across subgroups of the sample. Numbers of completed forms will provide descriptive insight into the uptake of the screening tool. Inter-rater reliability will provide insight into the tool's equivalence.
Measured: Over 4-6 months, from recruitment until the completion of screen implementation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study startOct 2025 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnosognosiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Devon and Exeter NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Alexis Clarke, DClinPsy, QiCN, Study director, University of Exeter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06940882
- Sponsor's protocol ID
- 24-25-17
- Status last verified
- Apr 2025
- First submitted
- 15 Apr 2025
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Exploration of the Acceptability and Feasibility of a Novel Screening Tool for Anosognosia After Stroke, Designed for Routine Use in Hospital Settings.
- ClinicalTrials.gov ID
- NCT06940882
- Acronym / sponsor ID
- 24-25-17
- Conditions
- Anosognosia, Stroke
- Keywords
- Anosognosia, Stroke, Assessment
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Collaborators
- Royal Devon and Exeter NHS Foundation Trust
- Study start
- Oct 2025 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 23 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Anosognosia, a neurological inability to acknowledge or comprehend one's own (dis)abilities, is a multi-faceted phenomenon which has consistently gained traction in research fields spanning psychology, neurology, and cognition since its conceptual introduction in 1914. Though anosognosia is not limited to following only neurological disease or injury, the majority of research has focused on the prevalence and mechanisms of anosognosia after stroke. Despite this, there is no clear consensus among the literature, and thus in clinical practice, as to how anosognosia after stroke should be assessed. This is startling given the plethora of studies which highlight anosognosia as a barrier to rehabilitation, a risk to safe discharge, and a predictor of poorer psychological and functional outcomes for both patients and their carers. Currently, there exists a vast number of assessment methods for anosognosia after stroke, which vary from performance- and observation-based tasks to self-report and discrepancy-based interviews; clinicians working in stroke make arbitrary choices as to which of these methods to use on a case-by-case basis, risking missed cases and subsequently noncomprehensive care. This research aims to develop a new screening tool for anosognosia that can be routinely implemented with post-stroke patients in hospital settings, to inform care, rehabilitation, and discharge. The study will explore the acceptability and feasibility of the new screening tool among multi-disciplinary staff working on a stroke rehabilitation unit, and provide grounds for future studies to assess the screen's psychometric properties and ability to inform novel interventions for anosognosia. Findings will have great implications for stroke survivors, their carers, and healthcare professionals alike.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –Patients admitted to a stroke rehabilitation unit following clinical diagnosis of stroke. Participation will involve completion of a new screening tool for anosognosia, to be administered by multi-disciplinary staff working on the stroke rehabilitation unit. |
| Staff | – | –Multi-disciplinary staff working on a stroke rehabilitation unit. Participation will involve administering a new screening tool for anosognosia with patients, and then attending focus groups to explore the acceptability and feasibility of the new screening tool among the staff group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stroke patients admitted to a stroke rehabilitation ward. Multi-disciplinary staff working with stroke patients on a stroke rehabilitation ward.
Key inclusion criteria (2 listed)
- Patients aged 18 years or above who are admitted to the stroke rehabilitation unit with a clinical diagnosis of stroke.
- Multi-disciplinary staff working on the stroke rehabilitation unit.
Key exclusion criteria (1 listed)
- Patients with a clinical diagnosis other than stroke.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Acceptability and Feasibility of new screening tool among multi-disciplinary staff
Time frame: From recruitment, throughout 4-6 months of screen implementation, to the completion of focus groups approximately 8 months after recruitment.
Focus groups will be conducted with staff who administer the new screening tool on the target stroke rehabilitation ward, to explore their views of and experiences with the tool. This will be in relation to the tool's content, structure, length, response/scoring formats, and administration demands.
1 secondary outcome
Uptake and Validity of new screening tool, with patients
Time frame: Over 4-6 months, from recruitment until the completion of screen implementation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexis Clarke, DClinPsy, QiCN contact
Alexis Clarke, DClinPsy, QiCN study director
University of Exeter
Questions about this trial
What is this clinical trial studying?
An observational study of Anosognosia and Stroke, run by University of Exeter.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Georgia M Williams, In Completion of DClinPsy (+447907685213, gw537@exeter.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability and Feasibility of new screening tool among multi-disciplinary staff (time frame: From recruitment, throughout 4-6 months of screen implementation, to the completion of focus groups approximately 8 months after recruitment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.