Determining important health score changes for older stroke patients
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
This study is trying to find out how much improvement in health scores older stroke patients feel is important to them after their stroke.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 125 (estimated) |
| Ages | 70 Years to 120 Years |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Locations | 2 sites (Amsterdam, North Holland and 1 other locations) |
| Trial ID | NCT06495073 on ClinicalTrials.gov |
What this trial studies
This observational study aims to establish the Minimal Clinically Important Difference (MCID) for two patient-reported outcome measures, the TOPICS-SF and PROMIS-10, specifically in older adults who have experienced an ischemic stroke or Transient Ischemic Attack (TIA). By employing an anchor-based method, the study will assess how much change in these scores is perceived as beneficial by patients. This research is crucial as it addresses a gap in the understanding of these measures' significance for older stroke survivors, who often have unique health needs. The findings could help tailor patient management and improve outcomes for this population.
Who should consider this trial
Good fit: Ideal candidates for this study are older adults aged 70 years or older who have recently suffered an ischemic stroke or TIA.
Not a fit: Patients who do not speak Dutch or are unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide clearer benchmarks for assessing health improvements in older stroke patients, leading to better patient care.
How similar studies have performed: While the approach to determining MCID is established, this specific application to the TOPICS-SF and PROMIS-10 in older stroke patients is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * not speaking Dutch; * being unable to answer questions; * being unable or not willing to give written informed consent.
Where this trial is running
Amsterdam, North Holland and 1 other locations
- OLVG, locatie West — Amsterdam, North Holland, Netherlands (Not_yet_recruiting)
- Amsterdam UMC, locatie AMC — Amsterdam, North Holland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Renske van den Berg-Vos, Prof, dr. — Amsterdam UMC, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands
- Study coordinator: Susanna R Prins, MSc
- Email: s.r.prins@amsterdamumc.nl
- Phone: 0031 20 566 9111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.