Development of a Novel Screening Tool for Anosognosia After Stroke.

April 23, 2025 updated by: University of Exeter

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Georgia M Williams, In Completion of DClinPsy
  • Phone Number: +447907685213
  • Email: gw537@exeter.ac.uk

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients with a clinical diagnosis other than stroke.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From recruitment, throughout 4-6 months of screen implementation, to the completion of focus groups approximately 8 months after recruitment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Uptake and Validity of new screening tool, with patients
Time Frame: Over 4-6 months, from recruitment until the completion of screen implementation.
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.
Over 4-6 months, from recruitment until the completion of screen implementation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Exeter

Collaborators

Royal Devon University Healthcare NHS Foundation Trust

Investigators

  • Study Director: Alexis Clarke, DClinPsy, QiCN, University of Exeter

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2025

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

April 15, 2025

First Submitted That Met QC Criteria

April 15, 2025

First Posted (Actual)

April 23, 2025

Study Record Updates

Last Update Posted (Actual)

April 27, 2025

Last Update Submitted That Met QC Criteria

April 23, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-25-17

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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