Determining the MCID for the TOPICS-SF and PROMIS-10 in Older Patients That Suffered an Ischemic Stroke or TIA
NCT ID: NCT06495073
Last Updated: 2024-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
125 participants
OBSERVATIONAL
2024-05-20
2024-12-31
Brief Summary
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Detailed Description
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The Minimal Clinically Important Difference (MCID) for PROMs is used to determine the clinical significance of differences in patients' scores. The MCID is defined as "the smallest difference in score in the domain of interest which patients perceive as beneficial and which would mandate, in the absence of troublesome side effects and excessive cost, a change in the patient's management".
MCID values vary across different populations. Despite the significance of MCID in interpreting PROM results, neither TOPICS-SF nor PROMIS-10 have established MCID values for the population of older adults that suffered a stroke.
One option to determine the MCID for these PROMs is a distribution-based method: this method compares the change in scores on the PROMS to statistical measures of spread of the data like the standard deviation. However, this approach may not always provide clinically relevant differences. A method that provides a more clinically meaningful MCID estimate is the anchor-based method.
With the anchor-based method, a specific question or "anchor" is chosen that is related to the concept being measured by the PROM. This anchor question typically asks participants about their perceived change in health or well-being over a specified period. For example, it might be a question like, "Has your physical health improved since ….?" The response options often include choices like "yes/no" or a range of improvement levels. The PROMs and the anchor questions are administered to the same group of participants, both before and after a specific time period. Based on the responses to the anchor question, participants are categorized into different groups like "improved" and "not improved". The MCID is then calculated using the predictive modeling approach. This technique uses statistical modeling techniques to analyze the relationship between changes in PROM scores and the categories established by the anchor question. The MCID value obtained through this process represents the minimum change in PROM scores that is considered clinically significant from the participant's perspective.
The investigators aim to determine the MCID for the TOPICS-SF and PROMIS-10 in people aged 70 or older that suffered an ischemic stroke or Transient Ischemic Attack (TIA), using an anchor-based method, to determine the clinical significance of differences in participant' scores.
This will be achieved through a prospective cohort study with no intervention. Participants will complete questionnaires at two time points: initially after providing informed consent during their hospital visit for diagnostic evaluation of the TIA or ischemic stroke, and then again four weeks later (with a two-week window, allowing for a range of two to six weeks). At the first time point, participants will complete the PROMIS-10 and elements D and E of the TOPICS-SF, which assess functional limitations and psychological well-being. At the second time point, participants will answer the same questions along with three additional anchor questions. The MCID for the PROMIS-10 and TOPICS-SF will be calculated using prognostic modeling techniques.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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PROMIS-10 and TOPICS-SF
There will be no intervention. The participants will be asked to fill in questionnaires at two time points: the first time will be after informed consent when they are at the hospital for diagnostic evaluation of the TIA or ischemic stroke, and the second time will be 4 weeks later, with a window of 2 weeks (allowing a range of 2-6 weeks). The second time point is chosen because the investigators suspect that by then, around 50% will be in the "improved" group. At the first time point, the participants will be asked to fill in the PROMIS-10 and element D and E of the TOPICS-SF - which are the elements used to determine the functional limitations and the psychological wellbeing. At the second time point, the participants will be asked to answer the same questions, as well as three additional anchor questions.
Eligibility Criteria
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Inclusion Criteria
* inclusion within a week after diagnosis of ischemic stroke or TIA
Exclusion Criteria
* being unable to answer questions;
* being unable or not willing to give written informed consent.
70 Years
120 Years
ALL
No
Sponsors
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Responsible Party
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Prof. dr. Nathalie van der Velde
Full Professor Geriatric medicine (internal medicine), Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Principal Investigators
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Renske van den Berg-Vos, Prof, dr.
Role: PRINCIPAL_INVESTIGATOR
Amsterdam UMC, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands
Nathalie van der Velde, Prof, dr
Role: PRINCIPAL_INVESTIGATOR
Amsterdam UMC, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands
Locations
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OLVG, locatie West
Amsterdam, North Holland, Netherlands
Amsterdam UMC, locatie AMC
Amsterdam, North Holland, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023.0822
Identifier Type: -
Identifier Source: org_study_id