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

CompletedNot a drug-phase studyRelapsing and progressiveNCT04979546

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Intensive Use of Patient Reported Outcome Measures and Open PROM Availability to Treating Neurologist

Compared with

  • Conservative Use of Patient Reported Outcome Measures and Blinded PROM Availability to Treating Neurologist

What it measured

Main measures

  • Difference in Change in Depression score in the Hospital Anxiety and Depression Scale (HADS-D) scores

    12 months

    Mood and sleep
  • Difference in Change in Anxiety score in the Hospital Anxiety and Depression Scale (HADS-A) scores

    12 months

    Mood and sleep

Other measures (6)

  • Difference in Change in the Euro Quality of Life Measurement (EQ5D)

    12 months

    Walking and mobilityPainMood and sleepQuality of life (reported by participants)
  • Difference in Change in the Modified Fatigue Impact Scale (MFIS) score

    12 months

    Thinking and memoryFatigue
  • Scores on Qualitative Consultant Satisfaction Questionnaire (CSQ)

    12 months

    Quality of life (reported by participants)
  • The Patient Determined Disease Steps (PDDS) Stability of Score

    12 months

    Disability progressionQuality of life (reported by participants)
  • Difference in Change in the Patient Health Questionnaire-9 (PHQ-9)

    12 months

    Mood and sleep
  • Difference in change in the CollaboRATE shared decision-making survey

    12 months

    Quality of life (reported by participants)

Who could take part

Relapsing and progressive · 18 and over

Show the full criteria

Inclusion criteria

* 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.

Exclusion criteria

* Unwilling/unable to provide consent. * Unwilling/unable to complete the questionnaires. * Does not speak English. * Under the age of 18. * Has a central nervous system inflammatory disorder other than MS. * PwMS not being managed by the participating neurologist (a neurologist practicing in Northern and Central Alberta).

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

Loading reviews and guidelines…

History

    1. Started

      Nov 2021

    2. Main results due

      Apr 2024

    3. Finished

      Apr 2024

    Assembled by software from public sources.