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

NCT06495073 | Recruiting

• 1 other identifier: 2023.0822
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Ischemic Stroke; TIA

Keywords

MCID; PROMIS-10; TOPICS-SF

Outcome Measures

Primary Outcomes (2)

• 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.

  4 weeks

• 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).

  4 weeks

Secondary Outcomes (2)

• MCID of the mental health score of the PROMIS-10

  4 weeks

• MCID of the physical health score of the PROMIS-10

  4 weeks

Interventions

PROMIS-10 and TOPICS-SF OTHER

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

• Age: 70 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• age = 70 years or older at the time of ischemic stroke or TIA;

You may not qualify if:

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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (2)

OLVG, locatie West

Amsterdam, North Holland, 1061 AE, Netherlands

NOT YET RECRUITING

Amsterdam UMC, locatie AMC

Amsterdam, North Holland, 1105AZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Renske van den Berg-Vos, Prof, dr.

  Amsterdam UMC, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands

  PRINCIPAL INVESTIGATOR

• Nathalie van der Velde, Prof, dr

  Amsterdam UMC, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susanna R Prins, MSc

CONTACT

0031 20 566 9111; s.r.prins@amsterdamumc.nl

Birgit A Damoiseaux-Volman,, PhD

CONTACT

0031 20 566 9111; b.a.damoiseaux@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor Geriatric medicine (internal medicine), Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 10, 2024
• Study Start: May 20, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: December 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After data-collection/analysis.
• Access Criteria: privacy laws of the Netherlands, including policy of NFU and AmsterdamUMC must be followed: * data will be shared anonymously * data can only be used to study the research question for which participants signed the ICF * data will not be shared for commercial purposes.

Locations

NL (2)