Predicting Cognitive Development in Younger Stroke Patients Using the Oxford Cognitive Screen

NCT05612815 | Unknown

• 1 other identifier: P-2022-525 from Pactius
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate whether Oxford Cognitive Screen (OCS) can be used as a predictive tool during hospital admission in younger (\<65 years) stroke patients, i.e. whether OCS is able to predict the level of cognitive functioning in these patients at 3- and 9-months post-stroke. Secondarily the investigators also want to examine the relationship between OCS scores and the patients' self-report regarding general level of functioning, and if there is a significant development in cognitive level over time by comparing OCS-scores at the different time points. The investigators predict that: a) Baseline OCS-score collected in the sub-acute phase during hospital admission will be helpful in predicting future level of cognitive functioning and level of general functioning: a low score at baseline will be associated with a relatively low score on the supplementary cognitive tests at 3- and 9-months post-stroke and a lower level of general functioning, and vice versa. B) Adding background information to the baseline data of the patients will improve the prediction regarding the future cognitive and general level of functioning. C) At 3- and 9-months post stroke we expect there to be a correlation between OCS-score and the patient's self-report of general functioning, where a low score on OCS will equal self-reports of low general functioning. D) The investigators expect to see significant differences in OCS-scores at different time points indicative of cognitive remission.

Conditions

Stroke

Keywords

Stroke; Cognition; Cognitive; Apoplexy; Cerebrovascular accident; Cerebral accident; Cerebral infarction; Oxford cognitive screen (OCS); Cognitive functioning; Post-stroke; Cognitive impairment; Neuropsychological evaluation; Cognitive test; Cognitive remission; Hospital anxiety and depression scale (HADS); Minimum data set home care (MDS-HC); Multiple fatigue inventory (MFI-20)

Outcome Measures

Primary Outcomes (4)

• Predicting cognitive outcome

  The patient will be tested with a neurocognitive battery. The test battery will be the same for each patient and will be used as the outcome measure for cognitive functioning. The tests are chosen from those that are widely used in the clinic during hospital admission and preferably have known Danish normative data. The reason for the supplementary neuropsychological testing is the limited sensitivity inherent to screening instruments. We will choose tests that correspond to the cognitive domains examined in the OCS. We will aggregate a sumscore (0-10) based on the number of domains the patient is impaired by using normative data associated with the specific tests. A low sumscore will correlate with little or no impairment whereas a high score will corelate with greater impairment. In the executive domain two tests are chosen to cover more aspects, and to increase sensitivity. If one of the tests indicates impairment, then the domain will be scored as impaired.

  at 3 months follow-up

• Predicting functional outcome

  MDS-HC will be used as a measure of functional outcome. Minimum data set - home care (MDS-HC): MDS-HC is an observation- and interview-based tool designed to be filled out by health care professionals for patients receiving home care. The questionnaire is designed to measure functional and cognitive impairments and pass on identification- and health-related information about the patient. In this study we will only use the section of the questionnaire containing questions regarding Instrumental Activities of Daily Living (IADL)-functions which will be filled out by interviewing the patient and if needed supplemented by interviewing someone close to the patient, preferably a person cohabitating with the patient. The questions regarding IADL is rated both with regards to how well the patient performs a task, but also with regards to how difficult it is for the patient to do the task. The questions have been informally translated to Danish and will be used in this form.

  at 3 months follow-up

• Predicting cognitive outcome

  The patient will be tested with a neurocognitive battery. The test battery will be the same for each patient and will be used as the outcome measure for cognitive functioning. The tests are chosen from those that are widely used in the clinic during hospital admission and preferably have known Danish normative data. The reason for the supplementary neuropsychological testing is the limited sensitivity inherent to screening instruments. We will choose tests that correspond to the cognitive domains examined in the OCS. We will aggregate a sumscore (0-10) based on the number of domains the patient is impaired by using normative data associated with the specific tests. A low sumscore will correlate with little or no impairment whereas a high score will corelate with greater impairment. In the executive domain two tests are chosen to cover more aspects, and to increase sensitivity. If one of the tests indicates impairment, then the domain will be scored as impaired.

  at 9 months follow-up

• Predicting functional outcome

  MDS-HC will be used as a measure of functional outcome. Minimum data set - home care (MDS-HC): MDS-HC is an observation- and interview-based tool designed to be filled out by health care professionals for patients receiving home care. The questionnaire is designed to measure functional and cognitive impairments and pass on identification- and health-related information about the patient. In this study we will only use the section of the questionnaire containing questions regarding IADL-functions which will be filled out by interviewing the patient and if needed supplemented by interviewing someone close to the patient, preferably a person cohabitating with the patient. The questions regarding IADL is rated both with regards to how well the patient performs a task, but also with regards to how difficult it is for the patient to do the task. The questions have been informally translated to Danish and will be used in this form.

  at 9 months follow-up

Secondary Outcomes (1)

• Change from baseline in the OCS-scores at 3- and 9-months

  At baseline, 3- and 9- months follow-up

Eligibility Criteria

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

Study Population

This study will include approximately 90 stroke patients recruited from the subacute stroke unit at Bispebjerg Hospital and the subacute stroke unit at Glostrup Hospital. The patients will be assessed three times: during their hospitalization, after 3 months and again after 9 months. The population of this study are patients admitted to the stroke units, who fulfill the above mentioned inclusion- and exclusion criteria.

You may qualify if:

• Patients must 1) be diagnosed with stroke, 2) have NIHSS on admission ≥ 2, 3) have findings on imaging confirming stroke, 4) be aged ≥ 18 \< 65, 5) achieve a score below cutoff in at least one partial assignment measured with OCS, 6) be capable of giving informed consent, 7) is able to communicate confidently in Danish.

You may not qualify if:

• Patients will be excluded if they 1) have a premorbid neurological illness that currently affect cognitive functions, 2) are delirious or suspected to be delirious at the time of baseline testing, 3) have a current or previously diagnosed brain tumor, 4) have a comorbid oncological illness that affect brain functions, 5) have reported alcohol abuse, 6) have a comorbid psychiatric disease necessitating treatment simultaneously with admission due to stroke.

Sponsors & Collaborators

• Bispebjerg Hospital: lead
• Glostrup University Hospital, Copenhagen: collaborator

Study Sites (1)

Bispebjerg hospital

Copenhagen, Capital Region, 2400, Denmark

Location

Related Publications (23)

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  BACKGROUND

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MeSH Terms

Conditions

Stroke; Cerebral Infarction; Cognitive Dysfunction; Depression

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Infarction; Brain Ischemia; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Hana M. Rytter, Ph.d Psych.

  RegionH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pernille C Pomiklo, ba.psych

CONTACT

+4538635250; pernille.crone.pomiklo@regionh.dk

Hana M Rytter, Ph.d Psych.

CONTACT

+4538635247; hana.mala.rytter@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 25, 2022
• First Posted: November 10, 2022
• Study Start: November 22, 2022
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: November 16, 2022

Record last verified: 2022-11

Locations

DK (1)