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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age70-120
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • PROMIS-10 and TOPICS-SF

    Other intervention

    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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
4 weeks
2

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).

Time frame
4 weeks

Secondary outcomes

1

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.

Time frame
4 weeks
2

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.

Time frame
4 weeks

Other outcomes

Sponsors and contacts

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