NCT04979546

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

Completed NA Last updated 19 September 2024

What this trial tests

NA trial testing Intensive Use of Patient Reported Outcome Measures and Open PROM Availability to Treating Neurologist in Multiple Sclerosis in 237 participants. Completed in 3 April 2024.

Timeline

4 November 2021

Primary endpoint
3 April 2024

3 April 2024

Quick facts

Lead sponsor	University of Alberta
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	237
Start date	4 November 2021
Primary completion	3 April 2024
Estimated completion	3 April 2024
Sites	1 location across Canada

Drugs / interventions tested

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

Conditions studied

• Multiple Sclerosis — all drugs for Multiple Sclerosis →
• Anxiety — all drugs for Anxiety →
• Depression — all drugs for Depression →
• Patient Satisfaction — all drugs for Patient Satisfaction →

Sponsor

University of Alberta

Who can join

18 and older, any sex, with Multiple Sclerosis or Anxiety. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Understanding Depression in People Living with Multiple Sclerosis: A Narrative Review of Recent Literature.
   Sullivan AB, Davis B, Kidd J, Chiong-Rivero H. · · 2025 · cited 5× · PMID 40146488 · DOI 10.1007/s40120-025-00728-8
2. Evaluating the impact of patient-reported outcome measures on depression and anxiety levels in people with multiple sclerosis: a study protocol for a randomized controlled trial.
   Chu NY, Watson KE, Al Hamarneh YN, Yushko L, et al · · 2023 · cited 4× · PMID 36732694 · DOI 10.1186/s12883-023-03090-0
3. Provider Experiences With Systematically Administered Patient-Reported Outcome Measures in Multiple Sclerosis: A Qualitative Sub-Study.
   Chu NY, Jamali A, Al Hamarneh YN, Watson KE, et al · · 2025 · PMID 40656127 · DOI 10.1212/cpj.0000000000200486
4. Evaluating the impact of systematic reporting of patient-reported outcome measures on depression and anxiety levels in people with multiple sclerosis: a randomized controlled trial.
   Chu NY, Yushko L, Pan B, Hamarneh YNA, et al · · 2025 · PMID 40339265 · DOI 10.1016/j.msard.2025.106502