- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07484048
A Modified Test of Goal-directed Behaviour: a Feasibility Study
Feasibility Study for Development of a Modified Bedside Test of Goal-directed Behaviour
Cognitive assessment plays an important part in decision making in acute neurological settings, partly because difficulties with cognitive skills such as attention, memory and executive functioning (which includes planning and problem-solving) have direct implications for patents' levels of independence and safety upon discharge.
A bedside cognitive task that could shed light upon a patient's ability to demonstrate effective goal-directed behaviour (potentially along with other aspects of executive functioning such as cognitive flexibility) would be a useful addition to the existing repertoire of bedside cognitive assessments.
One such test could be 'Link's Cube'. The Link's Cube Test is impractical for bedside use in an acute ward setting, as it comprises 27 small blocks. The feasibility study aims to preserve the information that is provided by Link's Cube Test (i.e. an indication of the patient's ability to engage in goal-directed behaviour) whilst altering the testing material such that only nine, slightly larger blocks are used.
The objectives for the feasibility study are:
- To identify any practical difficulties in administration of the tests that may not be apparent without trialling them
- To generate information regarding the timing and sequence of overall administration and in particular the proposed modified Link's Cube test
- To obtain feedback from neuropsychologists about ease of administration of the proposed new test and to obtain their views regarding potential benefits
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Gloucestershire
-
Cheltenham, Gloucestershire, United Kingdom, GL53 7AN
- Cheltenham General Hospital
-
Gloucester, Gloucestershire, United Kingdom, GL1 3NN
- Gloucestershire Royal Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion criteria for the main (non-neuropsychologist) element include:
- General population. For convenience at this feasibility study stage this will be largely comprised of colleagues working with GHT, above the age of 18, with no upper age limit.
- Have given informed consent having followed the procedure in the protocol
- Have the physical/sensory abilities to undertake the test procedures (e.g. use of both hands, adequate vision)
- Sufficient English language to be able to follow test instructions
Exclusion criteria for the main (non-neuropsychologist) element include:
- Under the age of 18
- Refusal/inability to give informed consent
- Insufficient English language to be able to follow test instructions
- Using cognitive testing as part of their clinical work, or ongoing familiarity with cognitive tests.
- Working directly with the main investigator.
- Presence of a self-reported cognitive difficulty/neurological condition - not because that in itself would be problematic for test administration or for the information generated, but rather to avoid potential distress to participants were they to find the tests administered challenging.
- Presence of any physical/sensory/cognitive difficulty that would confound administration of the tasks, e.g. being partially sighted or having use of only one upper limb
- There are no exclusion criteria based on gender identity, ethnicity or handedness.
- There are no exclusion criteria relating to medication.
Inclusion criteria for the PPI (neuropsychologist) element include:
- clinical psychologists in GHT who have or have had a role that involves the administration of cognitive tests
- Have given informed consent having followed the procedure in the protocol
- Have the physical/sensory abilities to undertake the test procedures (e.g. use of both hands, adequate vision)
- Sufficient English language to be able to follow test instructions
Exclusion criteria for the PPI (neuropsychologist) element include:
- Under the age of 18
- Refusal/inability to give informed consent
- Insufficient English language to be able to follow test instructions
- Presence of a self-reported cognitive difficulty/neurological condition - not because that in itself would be problematic for test administration or for the information generated, but rather to avoid potential distress to participants were they to find the tests administered challenging.
- Presence of any physical/sensory/cognitive difficulty that would confound administration of the tasks, e.g. being partially sighted or having use of only one upper limb
- There are no exclusion criteria based on gender identity, ethnicity or handedness.
- There are no exclusion criteria relating to medication.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Neuropsychologists
Clinical psychologists in Gloucestershire Hospitals NHS FT
|
The five tests are:
|
|
Other: Non-neuropsychologists
General population, non-neuropsychologists
|
The five tests are:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Procedural obstacles of the modified Link's Cube test.
Time Frame: Day 1
|
Assessed using the Link's Cube Scoring Matrix (total score between 0-30)
|
Day 1
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25/001/GHT
- 358626 (Other Identifier: IRAS)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Cognitive Impairment
-
Stanford UniversityRecruitingMild Cognitive Impairment | Subjective Cognitive ImpairmentUnited States
-
University of EdinburghNHS LothianNot yet recruitingCognitive Impairment | Anesthesia | Cognitive Impairment, Mild | Anesthesia Brain Monitoring | Cognitive Impairment, Progressive | Anesthesia Depth MonitoringUnited Kingdom
-
Fondazione Don Carlo Gnocchi OnlusUniversity of Florence; Consorzio di Bioingeneria e Informatica Medica; Gutenberg...CompletedCognitive Dysfunction | Mild Cognitive Impairment | Vascular Cognitive ImpairmentItaly
-
University of California, Los AngelesCompletedMild Cognitive Impairment (MCI) | Age-associated Cognitive ImpairmentUnited States
-
Universidad de ZaragozaRecruitingMild Cognitive Impairment | Randomized Controlled Trial | Subjective Cognitive ImpairmentSpain
-
BaycrestCentre for Aging and Brain Health InnovationUnknownNeurocognitive Disorders | Cognitive Dysfunction | Mental Disorder | Cognitive Impairment, Mild | Cognitive Disorder | Nonamnestic Mild Cognitive ImpairmentCanada
-
Region SkaneLund University; Berry LabCompletedMemory Impairment | Cognitive Impairment, MildSweden
-
Sunnybrook Health Sciences CentreRecruitingMild Cognitive Impairment | Vascular Cognitive ImpairmentCanada
-
University of GeorgiaApplied Universal Dynamics, Corp.; Van Robotics, Inc.Active, not recruitingRobot-assisted Cognitive Training for Lonely Older Adults With Mild Cognitive Impairment (MCI) (MCI)Cognitive Change | Aging | Cognitive Impairment, MildUnited States
-
University of HawaiiRecruitingMild Cognitive Impairment | Subjective Cognitive ImpairmentUnited States
Clinical Trials on Five cognitive tasks
-
University Hospital, GrenobleGrenoble Institut des NeurosciencesRecruitingCognition | Focal Brain InjuryFrance
-
Centre Hospitalier St AnneActive, not recruitingPsychiatric Diseases | Neurological Diseases or Conditions | Candidates for Deep Brain Stimulation | Candidates for Invasive S-EEG | Candidates for Awake SurgeryFrance
-
Centre Hospitalier St AnneCompleted
-
Nantes University HospitalCompleted
-
University Hospital, GrenobleCommissariat A L'energie Atomique; Laboratoire de Psychologie et NeuroCognitionCompleted
-
Universidade Federal do Rio Grande do NorteConselho Nacional de Desenvolvimento Científico e TecnológicoCompleted
-
University of California, Los AngelesDanone Nutricia ResearchCompleted
-
Centre Hospitalier Universitaire de Saint EtienneCompletedBipolar Affective DisorderFrance
-
Centre Hospitalier Universitaire de Saint EtienneCompleted
-
University of Wisconsin, MadisonNational Institute on Aging (NIA)Recruiting