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NCT04979546Completed

Using Patient-Reported Outcomes To Improve the Care of People With Multiple Sclerosis

Using Patient-Reported Outcomes To Improve the Care of People With Multiple Sclerosis: A Randomized Trial

Source: ClinicalTrials.gov · Last updated 19 Sept 2024

Brief summary (registry, in English)

The proposed trial is a prospective, randomized (1:1) trial plan examining whether more routine and frequent measurement of Patient Related Outcome Measures (PROMs) in the care of patients with MS improves patient depression and anxiety outcomes in addition to patient care satisfaction. The investigators plan to randomize people with MS (PwMS) to an intensive arm of filling out patient reported outcome measures every 6 months, with communication to their neurologist about their scores, versus a control arm, where participants fill out patient reported outcomes less frequently (annually) and their scores are not released to their MS Clinic/Neurologist. The primary outcome is to see if more frequent PROM completion leads to less depression and anxiety for people with MS. The investigators also plan to measure their satisfaction of care with their MS Clinic/neurologist and satisfaction in a shared decision-making process. Whether this improves care in patients with MS is currently unknown, and the investigators want to explore this with the current study. The investigators plan to randomize people with MS (PwMS) to an intensive arm of filling out patient reported outcome measures every 6 months, with communication to their neurologist about their scores, versus a control arm, where participants fill out patient reported outcomes less frequently (annually) and their scores are not released to their MS Clinic/Neurologist. The primary outcome is to see if more frequent PROM completion leads to less anxiety for people with MS. The investigators also plan to measure their satisfaction of care with their MS Clinic/neurologist and satisfaction in a shared decision-making process.

Status (registry)
Completed
Study type
Interventional
Enrollment
237 (actual)
First submitted
6 Jul 2021
Start date
4 Nov 2021
Primary completion date
3 Apr 2024
Lead sponsor
University of Alberta
NCT number
NCT04979546

What you commit to

  • Study type: Interventional
  • Participants enrolled: 237
  • From 4 Nov 2021 to the primary completion date, 3 Apr 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Has a central nervous system inflammatory disorder other than MS.

Age

  • Under the age of 18.

Other

  • Unwilling/unable to provide consent.
  • Unwilling/unable to complete the questionnaires.
  • Does not speak English.
  • PwMS not being managed by the participating neurologist (a neurologist practicing in Northern and Central Alberta).

Who the study is looking for

  • Persons with multiple sclerosis \[relapsing-remitting, secondary progressive, primary progressive, etc.\] being managed by a Northern or Central Alberta-based neurologist.
  • Able/willing to complete informed consent and the questionnaires.
  • Able to use a computer.
  • Greater or equal to the age of 18 years old.
  • English-speaking.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Alberta
Coordinator of this site? Confirm its status
EdmontonCanadaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.