About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
age = 70 years or older at the time of ischemic stroke or TIA;
inclusion within a week after diagnosis of ischemic stroke or TIA
Disqualifiers
not speaking Dutch;
being unable to answer questions;
being unable or not willing to give written informed consent.
Trial population
The patient population consists of older (\>=70 yrs) patients with a recent acute ischemic stroke or TIA who are admitted to or Amsterdam UMC location AMC or the OLVG West hospital, or visit the outpatient clinic or emergency department of one of these hospitals for diagnostic evaluation. Diagnosis of ischemic stroke or TIA will be left to the discretion of the neurologist.
Trial design
Cohort
Prospective
Treatments tested in this trial
PROMIS-10 and TOPICS-SF
Other interventionThere 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.
Treatment groups
Trial outcomes
Primary outcomes
MCID of the PROMIS-10
The Minimal Clinically Important Difference (MCID) of the Patient-Reported Outcomes Measurement Information System Global Health Short Form(PROMIS-10) will be calculated using an achor-based approach. The PROMIS-10 has scores ranging from 10 to 50, where higher scores indicate better health status.
MCID of the TOPICS-SF
The Minimal Clinically Important Difference (MCID) of the The Older Persons and Informal Caregivers Survey Short Form (TOPICS-SF) will be calculated using an achor-based approach. Of the TOPICS-SF, the investigators will use the questions regarding physical and psychological wellbeing (section D and E). These sections have combined scores ranging from 0 (worst) to 54 (best).
Secondary outcomes
MCID of the mental health score of the PROMIS-10
Since the Patient-Reported Outcomes Measurement Information System Global Health Short Form(PROMIS-10) provides subscales for mental health (ranging from 4 to 20 points, higher scores indicating better mental health), as well as a global measure of the health related quality of life, the investigators will try to calculate the The Minimal Clinically Important Difference (MCID) for the mental health subscale.
MCID of the physical health score of the PROMIS-10
Since the Patient-Reported Outcomes Measurement Information System Global Health Short Form(PROMIS-10) provides subscales for physical health (ranging from 4 to 20 points, higher scores indicating better physical health), as well as a global measure of the health related quality of life, the investigators will try to calculate the The Minimal Clinically Important Difference (MCID) for the physical health subscale.
Sponsors and contacts
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead sponsor
Amsterdam UMC, location AMC
Sponsor institution