Development of a Novel Screening Tool for Anosognosia After Stroke.

NCT06940882 | Not Yet Recruiting

• 1 other identifier: 24-25-17
• Study Type: observational
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Over 4-6 months, from recruitment until the completion of screen implementation.

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Stroke patients admitted to a stroke rehabilitation ward. Multi-disciplinary staff working with stroke patients on a stroke rehabilitation ward.

You may qualify if:

• 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.

You may not qualify if:

• Patients with a clinical diagnosis other than stroke.

Sponsors & Collaborators

• University of Exeter: lead
• Royal Devon and Exeter NHS Foundation Trust: collaborator

MeSH Terms

Conditions

Agnosia; Stroke

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Alexis Clarke, DClinPsy, QiCN

  University of Exeter

  STUDY DIRECTOR

Central Study Contacts

Georgia M Williams, In Completion of DClinPsy

CONTACT

+447907685213; gw537@exeter.ac.uk

Alexis Clarke, DClinPsy, QiCN

CONTACT

alexis.clarke8@exeter.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: April 23, 2025
• Study Start: October 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 27, 2025

Record last verified: 2025-04