StrokeSTROKYNCT05612815
Predicting Cognitive Development in Younger Stroke Patients Using the Oxford Cognitive Screen
An observational study of Stroke, run by Bispebjerg Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Stroke
- How many people
- 90 participants
- Where
- 1 siteDenmark
- Study dates
- 22 Nov 2022to 1 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Bispebjerg hospital
Copenhagen, Capital Region, 2400
Pernille C. Pomiklo, ba.psych, +45 38635250, pernille.crone.pomiklo@regionh.dk
Hana M. Rytter, Ph.d Psych., +45 38635247, hana.mala.rytter@regionh.dk
About this study
Official title: 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.
Read the 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.
- 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)
- Medical subject headings
- Stroke, Cerebral Infarction, Cognitive Dysfunction, Depression
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at 9 months follow-up
Secondary outcomes (1)
Change from baseline in the OCS-scores at 3- and 9-months
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.
Measured: At baseline, 3- and 9- months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start22 Nov 2022 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Glostrup University Hospital, Copenhagen
- Responsible party
- Principal investigator, Hana Malá Rytter, Bispebjerg Hospital
- Investigators
- Hana M. Rytter, Ph.d Psych., Principal investigator, Center for Health, The Capital Region of Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05612815
- Sponsor's protocol ID
- P-2022-525 from Pactius
- Acronym
- STROKY
- Status last verified
- Nov 2022
- First submitted
- 25 Oct 2022
- Last updated
- 16 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Publications
Boot E, Ekker MS, Putaala J, Kittner S, De Leeuw FE, Tuladhar AM. Ischaemic stroke in young adults: a global perspective. J Neurol Neurosurg Psychiatry. 2020 Apr;91(4):411-417. doi: 10.1136/jnnp-2019-322424. Epub 2020 Feb 3.
PubMed 32015089Buvarp D, Rafsten L, Abzhandadze T, Sunnerhagen KS. A prospective cohort study on longitudinal trajectories of cognitive function after stroke. Sci Rep. 2021 Aug 26;11(1):17271. doi: 10.1038/s41598-021-96347-y.
PubMed 34446763Demeyere N, Riddoch MJ, Slavkova ED, Bickerton WL, Humphreys GW. The Oxford Cognitive Screen (OCS): validation of a stroke-specific short cognitive screening tool. Psychol Assess. 2015 Sep;27(3):883-94. doi: 10.1037/pas0000082. Epub 2015 Mar 2.
PubMed 25730165George MG, Tong X, Kuklina EV, Labarthe DR. Trends in stroke hospitalizations and associated risk factors among children and young adults, 1995-2008. Ann Neurol. 2011 Nov;70(5):713-21. doi: 10.1002/ana.22539. Epub 2011 Sep 2.
PubMed 21898534Groppo E, De Gennaro R, Granieri G, Fazio P, Cesnik E, Granieri E, Casetta I. Incidence and prognosis of stroke in young adults: a population-based study in Ferrara, Italy. Neurol Sci. 2012 Feb;33(1):53-8. doi: 10.1007/s10072-011-0654-9. Epub 2011 Jun 22.
PubMed 21695657Kissela BM, Khoury JC, Alwell K, Moomaw CJ, Woo D, Adeoye O, Flaherty ML, Khatri P, Ferioli S, De Los Rios La Rosa F, Broderick JP, Kleindorfer DO. Age at stroke: temporal trends in stroke incidence in a large, biracial population. Neurology. 2012 Oct 23;79(17):1781-7. doi: 10.1212/WNL.0b013e318270401d. Epub 2012 Oct 10.
PubMed 23054237Landi F, Tua E, Onder G, Carrara B, Sgadari A, Rinaldi C, Gambassi G, Lattanzio F, Bernabei R; SILVERNET-HC Study Group of Bergamo. Minimum data set for home care: a valid instrument to assess frail older people living in the community. Med Care. 2000 Dec;38(12):1184-90. doi: 10.1097/00005650-200012000-00005.
PubMed 11186297Mancuso M, Demeyere N, Abbruzzese L, Damora A, Varalta V, Pirrotta F, Antonucci G, Matano A, Caputo M, Caruso MG, Pontiggia GT, Coccia M, Ciancarelli I, Zoccolotti P; Italian OCS Group. Using the Oxford Cognitive Screen to Detect Cognitive Impairment in Stroke Patients: A Comparison with the Mini-Mental State Examination. Front Neurol. 2018 Feb 28;9:101. doi: 10.3389/fneur.2018.00101. eCollection 2018.
PubMed 29541055Manoli R, Chartaux-Danjou L, Delecroix H, Daveluy W, Moroni C. Is Multidimensional Fatigue Inventory (MFI-20) adequate to measure brain injury related fatigue? Disabil Health J. 2020 Jul;13(3):100913. doi: 10.1016/j.dhjo.2020.100913. Epub 2020 Mar 26.
PubMed 32273197Marini C, Russo T, Felzani G. Incidence of stroke in young adults: a review. Stroke Res Treat. 2010 Dec 19;2011:535672. doi: 10.4061/2011/535672.
PubMed 21197401Middleton LE, Lam B, Fahmi H, Black SE, McIlroy WE, Stuss DT, Danells C, Ween J, Turner GR. Frequency of domain-specific cognitive impairment in sub-acute and chronic stroke. NeuroRehabilitation. 2014;34(2):305-12. doi: 10.3233/NRE-131030.
PubMed 24401826Morris JN, Fries BE, Steel K, Ikegami N, Bernabei R, Carpenter GI, Gilgen R, Hirdes JP, Topinkova E. Comprehensive clinical assessment in community setting: applicability of the MDS-HC. J Am Geriatr Soc. 1997 Aug;45(8):1017-24. doi: 10.1111/j.1532-5415.1997.tb02975.x.
PubMed 9256857Morsund AH, Ellekjaer H, Gramstad A, Reiestad MT, Midgard R, Sando SB, Jonsbu E, Naess H. The development of cognitive and emotional impairment after a minor stroke: A longitudinal study. Acta Neurol Scand. 2019 Oct;140(4):281-289. doi: 10.1111/ane.13143. Epub 2019 Jul 15.
PubMed 31265131Nawaz B, Eide GE, Fromm A, Oygarden H, Sand KM, Thomassen L, Naess H, Waje-Andreassen U. Young ischaemic stroke incidence and demographic characteristics - The Norwegian stroke in the young study - A three-generation research program. Eur Stroke J. 2019 Dec;4(4):347-354. doi: 10.1177/2396987319863601. Epub 2019 Jul 16.
PubMed 31903433Petersen, A. H., Forchhammer, B. H. (2020). Neuropsykologisk rehabilitering i: Starrfelt, R., Gerlach, C. & Gade, A. (Red.), Klinisk neuropsykologi (s. 509-524). Frydenlund.
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Cognitive Development in Younger Stroke Patients Using the Oxford Cognitive Screen (STROKY)
- ClinicalTrials.gov ID
- NCT05612815
- Acronym / sponsor ID
- STROKY / P-2022-525 from Pactius
- Conditions
- Stroke
- Keywords
- Stroke, Cognition, Cognitive, Apoplexy, Cerebrovascular accident, Cerebral accident, Cerebral infarction, Oxford cognitive screen (OCS)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- Glostrup University Hospital, Copenhagen
- Study start
- 22 Nov 2022 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 10 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
1 secondary outcome
Change from baseline in the OCS-scores at 3- and 9-months
Time frame: At baseline, 3- and 9- months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2022.
- Background: PubMed 32015089Boot E, Ekker MS, Putaala J, Kittner S, De Leeuw FE, Tuladhar AM. Ischaemic stroke in young adults: a global perspective. J Neurol Neurosurg Psychiatry. 2020 Apr;91(4):411-417. doi: 10.1136/jnnp-2019-322424. Epub 2020 Feb 3.
- Background: PubMed 34446763Buvarp D, Rafsten L, Abzhandadze T, Sunnerhagen KS. A prospective cohort study on longitudinal trajectories of cognitive function after stroke. Sci Rep. 2021 Aug 26;11(1):17271. doi: 10.1038/s41598-021-96347-y.
- Background: PubMed 25730165Demeyere N, Riddoch MJ, Slavkova ED, Bickerton WL, Humphreys GW. The Oxford Cognitive Screen (OCS): validation of a stroke-specific short cognitive screening tool. Psychol Assess. 2015 Sep;27(3):883-94. doi: 10.1037/pas0000082. Epub 2015 Mar 2.
- Background: PubMed 21898534George MG, Tong X, Kuklina EV, Labarthe DR. Trends in stroke hospitalizations and associated risk factors among children and young adults, 1995-2008. Ann Neurol. 2011 Nov;70(5):713-21. doi: 10.1002/ana.22539. Epub 2011 Sep 2.
- Background: PubMed 21695657Groppo E, De Gennaro R, Granieri G, Fazio P, Cesnik E, Granieri E, Casetta I. Incidence and prognosis of stroke in young adults: a population-based study in Ferrara, Italy. Neurol Sci. 2012 Feb;33(1):53-8. doi: 10.1007/s10072-011-0654-9. Epub 2011 Jun 22.
- Background: PubMed 23054237Kissela BM, Khoury JC, Alwell K, Moomaw CJ, Woo D, Adeoye O, Flaherty ML, Khatri P, Ferioli S, De Los Rios La Rosa F, Broderick JP, Kleindorfer DO. Age at stroke: temporal trends in stroke incidence in a large, biracial population. Neurology. 2012 Oct 23;79(17):1781-7. doi: 10.1212/WNL.0b013e318270401d. Epub 2012 Oct 10.
- Background: PubMed 11186297Landi F, Tua E, Onder G, Carrara B, Sgadari A, Rinaldi C, Gambassi G, Lattanzio F, Bernabei R; SILVERNET-HC Study Group of Bergamo. Minimum data set for home care: a valid instrument to assess frail older people living in the community. Med Care. 2000 Dec;38(12):1184-90. doi: 10.1097/00005650-200012000-00005.
- Background: PubMed 29541055Mancuso M, Demeyere N, Abbruzzese L, Damora A, Varalta V, Pirrotta F, Antonucci G, Matano A, Caputo M, Caruso MG, Pontiggia GT, Coccia M, Ciancarelli I, Zoccolotti P; Italian OCS Group. Using the Oxford Cognitive Screen to Detect Cognitive Impairment in Stroke Patients: A Comparison with the Mini-Mental State Examination. Front Neurol. 2018 Feb 28;9:101. doi: 10.3389/fneur.2018.00101. eCollection 2018.
- Background: PubMed 32273197Manoli R, Chartaux-Danjou L, Delecroix H, Daveluy W, Moroni C. Is Multidimensional Fatigue Inventory (MFI-20) adequate to measure brain injury related fatigue? Disabil Health J. 2020 Jul;13(3):100913. doi: 10.1016/j.dhjo.2020.100913. Epub 2020 Mar 26.
- Background: PubMed 21197401Marini C, Russo T, Felzani G. Incidence of stroke in young adults: a review. Stroke Res Treat. 2010 Dec 19;2011:535672. doi: 10.4061/2011/535672.
- Background: PubMed 24401826Middleton LE, Lam B, Fahmi H, Black SE, McIlroy WE, Stuss DT, Danells C, Ween J, Turner GR. Frequency of domain-specific cognitive impairment in sub-acute and chronic stroke. NeuroRehabilitation. 2014;34(2):305-12. doi: 10.3233/NRE-131030.
- Background: PubMed 9256857Morris JN, Fries BE, Steel K, Ikegami N, Bernabei R, Carpenter GI, Gilgen R, Hirdes JP, Topinkova E. Comprehensive clinical assessment in community setting: applicability of the MDS-HC. J Am Geriatr Soc. 1997 Aug;45(8):1017-24. doi: 10.1111/j.1532-5415.1997.tb02975.x.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hana M. Rytter, Ph.d Psych. principal investigator
Center for Health, The Capital Region of Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Bispebjerg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pernille C Pomiklo, ba.psych (+4538635250, pernille.crone.pomiklo@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predicting cognitive outcome (time frame: at 3 months follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05612815, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2022.