Predicting Cognitive Development in Younger Stroke Patients Using the Oxford Cognitive Screen (STROKY)

November 15, 2022 updated by: Hana Malá Rytter, Bispebjerg Hospital

Predicting Cognitive Development in Younger Stroke Patients Using the Oxford Cognitive Screen (STROKY)

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.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

One of the fastest ways to assess patients' level of cognitive functioning is by using screening tools, which have a short administration time and can be applied to a broad group of patients, in contrast to a full neuropsychological evaluation. Nevertheless, since the screening tools consist of a range of subtests across cognitive domains, they do allow for making relatively general assumptions for the patient group the investigators examine. Studies with similar purpose have been performed previously, however, they have applied cognitive screening tools developed originally to target other populations than stroke, such as dementias. In contrast, in this study the investigators will use the Oxford Cognitive Screen (OCS), a tool developed specifically to target stroke patients. The investigators have chosen to focus on stroke population of working-age adults, since predicting future levels of cognitive functioning bears a special relevance for this group due to future work life and/or education, and since even a mild cognitive impairment can have far-reaching consequences.

Setting and recruitment:

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 project will not impact the rehabilitation of the patients in that the patients will receive standard rehabilitation care during the course of the study.

A research assistant will look over the list of patients hospitalized at the stroke units weekly and will recruit patients that comply with the inclusion and exclusion criteria. At baseline the patients will be tested with OCS either by a research assistant, neuropsychologist or a therapist working at the specific stroke unit, that has received training by a neuropsychologist to perform the testing. The patient will also be asked to fill out Hospital Anxiety and Depression Scale (HADS) and will be asked about the baseline information that are not deductible from the medical journal (see section about baseline measures).

The follow up sessions will take place either in the home address of the patient or at Bispebjerg- or Glostrup Hospital where they will be invited in advance according to their preferences. The subjects will receive a link and QR-code via e-mail a week in advance to the follow-up session to fill out questionnaires described in the section "3- and 9-month measures". At the follow-up sessions they will be interviewed to fill out MDS-HC, tested with OCS and tested with supplementary cognitive tests by a research assistant. If they have not filled out the questionnaires in advance, the research assistant will help them to do so during the test session.

Sample size assessment based on power calculations:

To be able to prove a small effect size (d = 0.15) in the linear regressions the investigators need to include at least 55 patients.

To be able to prove a small effect size (d = 0.15) in the Repeated Measures ANOVA the investigators need to include at least 73 patients.

Because the Correlation analysis is not used to obtain results about the main objective, which is to predict future cognitive level, a possible larger effect size (d = 0.3) is accepted. To prove a minimum of d=0.3, the investigators need at least 82 patients in the final analysis. The investigators choose therefore to include 90 patients, assuming possible dropout.

Plan for missing data:

Missing/Unavailable/Non-reported/ Uninterpretable or considered missing because of data inconsistency: The investigators will primarily use Maximum Likelihood Estimation to make imputations when data is missing.

Out-of-range results: When the investigators identify an outlier, it will be investigated whether there might be an obvious cause that is unrelated to what the investigators are trying to measure. If this is the case, the datapoint will be ruled out, otherwise it will be part of the final analysis and would be considered as natural variation.

Statistical analysis plan describing the analytical principles and statistical techniques to be employed: The investigators plan to perform 6 separate multiple linear regressions. Prognostic variables will be chosen for each multiple linear regression based on their correlation with the specific outcome variable. Significance would be considered achieved at p < .10.

The possible prognostic variables will be the same in all 6 analyses and are as follows:

Age, sex, years of education, type of stroke, location of stroke, NIHSS-score, additional treatment, HADS-scores at baseline, OCS-score at baseline, pre-stroke working situation, housing situation, cohabitant status, alcohol intake, and physical exercise level. Initially, the investigators will perform a correlation analysis between the possible predictors and outcome. Those that correlate significantly with outcome will be used for regression analysis.

The investigators will perform a separate analysis for each outcome variable as follows:

MDS-HC performance-score after 3 months, MDS-HC difficulty-score after 3 months, MDS-HC performance-score after 9 months, MDS-HC difficulty-score after 9 months, scores of the supplementary cognitive tests after 3 months and scores of the supplementary cognitive tests after 9 months.

Repeated measures ANOVA The investigators plan to perform a repeated measures ANOVA to test if the OCS-score changes over time. This analysis will be corrected for influence of depression and anxiety symptoms and fatigue by correcting for HADS-scores and MFI-20-score. If this test proves significant, pairwise comparisons will be done (LSD-t-test). Significance would be considered achieved at p < .05.

Correlational analyses The investigators plan to perform analyses of correlations between MDS-HC- and OCS-scores. One will be done for the variables at 3 months, and one will be done for the variables at 9 months.

The investigators also plan to perform correlational analyses of the OCS-scores and the scores on the supplementary cognitive tests. One will be done for the variables at 3 months, and one will be done for the variables at 9 months. Significance would be considered achieved at p < .05.

To be able to explain results of the latter correlational analyses between OCS-scores and the scores on supplementary tests the investigators want to execute McNemar's test and Kappa measure of agreement. This is to further theorize how the results of the separate subtests in OCS relates to the subtests of the supplementary testing. These analyses will be done for each OCS-subtest matched to the corresponding subtest of the supplementary test battery. Significance in McNemar's test would be considered achieved at p < .05.

Study Type

Observational

Enrollment (Anticipated)

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

Study Contact Backup

Study Locations

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

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predicting cognitive outcome
Time Frame: at 3 months follow-up
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
Time Frame: at 3 months follow-up
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
Time Frame: at 9 months follow-up
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
Time Frame: at 9 months follow-up
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in the OCS-scores at 3- and 9-months
Time Frame: At baseline, 3- and 9- months follow-up
Oxford Cognitive Screen (OCS) is a cognitive screening-tool developed specifically to target the cognitive domains frequently affected in stroke patients. The screening covers 5 overall cognitive domains: attention and executive function, language, memory, number processing and praxis, and consists of a total of 10 subtests. OCS generates a subscore for each subtest and provides information about the individual cut-off value. OCS can also generate a total sum score that ranges from 0-10 depending on the number of subtests with performance below cut-off, with 10 reflecting impairments in all cognitive domains. For the purpose of this study, we will use the sum score. This is chosen to get a broader view of the cognitive status as well as changes over time and is deemed appropriate for research purposes. The screening tool has been translated to Danish and provided with Danish normative data.
At baseline, 3- and 9- months follow-up

Collaborators and Investigators

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

Sponsor

Bispebjerg Hospital

Collaborators

Glostrup University Hospital, Copenhagen

Investigators

  • Principal Investigator: Hana M. Rytter, Ph.d Psych., RegionH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

November 22, 2022

Primary Completion (Anticipated)

October 1, 2024

Study Completion (Anticipated)

October 1, 2024

Study Registration Dates

First Submitted

October 25, 2022

First Submitted That Met QC Criteria

November 8, 2022

First Posted (Actual)

November 10, 2022

Study Record Updates

Last Update Posted (Actual)

November 16, 2022

Last Update Submitted That Met QC Criteria

November 15, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P-2022-525 from Pactius

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

When participants have signed the declaration of consent, they could choose whether or not we can contact them in the future for the use of their data in relevant projects. We do not know for sure whether it is going to be relevant to share this information.

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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