RecruitingNCT06495073

Determining the MCID for the TOPICS-SF and PROMIS-10 in Older Patients That Suffered an Ischemic Stroke or TIA

Determining the Minimal Clinically Important Difference (MCID) for the TOPICS-SF and PROMIS-10 in Older Patients That Suffered an Ischemic Stroke or Transient Ischemic Attack (TIA), Using an Anchor-based Approach


Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Enrollment

125 participants

Start Date

May 20, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

Patient-related outcome measures (PROMs) play a crucial role in assessing patient outcomes in healthcare. Two of these PROMs are the The Older Persons and Informal Caregivers Survey Short Form (TOPICS-SF) and Patient-Reported Outcomes Measurement Information System Global Health Short Form (PROMIS-10). The investigators aim to determine the Minimal Clinically Important Difference (MCID) for the TOPICS-SF and PROMIS-10 in older people that suffered an ischemic stroke or Transient Ischemic Attack (TIA), using an anchor-based method.


Eligibility

Min Age: 70 YearsMax Age: 120 Years

Inclusion Criteria2

  • age = 70 years or older at the time of ischemic stroke or TIA;
  • inclusion within a week after diagnosis of ischemic stroke or TIA

Exclusion Criteria3

  • not speaking Dutch;
  • being unable to answer questions;
  • being unable or not willing to give written informed consent.

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Interventions

OTHERPROMIS-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.


Locations(2)

OLVG, locatie West

Amsterdam, North Holland, Netherlands

Amsterdam UMC, locatie AMC

Amsterdam, North Holland, Netherlands

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NCT06495073


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