← Back to Search

PROMs for Multiple Sclerosis Care

N/A

Recruiting

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Greater or equal to the age of 18 years old

Persons with multiple sclerosis [relapsing-remitting, secondary progressive, primary progressive, etc.] being managed by a Northern or Central Alberta-based neurologist

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial is 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.

Who is the study for?

This trial is for English-speaking adults over 18 with multiple sclerosis (MS) managed by a neurologist in Northern or Central Alberta. Participants must be able to use a computer and willing to complete questionnaires. Those unable to consent, complete the surveys, under 18, or with other central nervous system inflammatory disorders besides MS are excluded.Check my eligibility

What is being tested?

The study tests if more frequent reporting of patient feelings and experiences (every 6 months) improves mental health and satisfaction with care compared to less frequent reporting (annually). One group's reports will be shared with their neurologist; the control group's won't.See study design

What are the potential side effects?

Since this trial involves completing questionnaires rather than taking medication, there are no direct physical side effects. However, discussing personal health issues frequently may have emotional impacts on participants.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

I have multiple sclerosis and am under the care of a neurologist in Northern or Central Alberta.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Anxiety

Secondary outcome measures

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

Difference in Change in the Modified Fatigue Impact Scale (MFIS) score

Difference in Change in the Patient Health Questionnaire-9 (PHQ-9)

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intensive PROMs Intervention ArmExperimental Treatment1 Intervention

The intervention group will be asked to complete PROM questionnaires at baseline, 6 months, and 12 months via an online web-based delivery system. The treating neurologist will be prompted to view the text response to the 3-item prompt in addition to the PROM questionnaire scores for participants in the interventional group. Treating neurologist will also be alerted if participates reach certain critical threshold scores or decrement on their PROM questionnaires. Participants randomized to the intervention group will be asked to complete CSQ and CollaboRATE questionnaires at baseline and at 12 months.

Group II: Control ArmActive Control1 Intervention

The control group will be asked to complete PROM questionnaires at baseline and 12 months via an online web-based delivery system. The treating neurologist will only be prompted to view the text response to the 3-item prompt, and will not be able to access the PROM questionnaire scores for participants in the control group (unless critical values are reached on questionnaires - see below). Treating neurologist will also be alerted if participates reach certain critical threshold scores or decrement on their PROM questionnaires. Participants randomized to the intervention group will be asked to complete CSQ and CollaboRATE questionnaires at baseline and at 12 months.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor

886 Previous Clinical Trials

384,422 Total Patients Enrolled

5 Trials studying Multiple Sclerosis

35,478 Patients Enrolled for Multiple Sclerosis

University Hospital FoundationOTHER

7 Previous Clinical Trials

1,030 Total Patients Enrolled

1 Trials studying Multiple Sclerosis

248 Patients Enrolled for Multiple Sclerosis

Media Library

Intensive Use of Patient Reported Outcome Measures and Open PROM Availability to Treating Neurologist Clinical Trial Eligibility Overview. Trial Name: NCT04979546 — N/A

Multiple Sclerosis Research Study Groups: Intensive PROMs Intervention Arm, Control Arm

Multiple Sclerosis Clinical Trial 2023: Intensive Use of Patient Reported Outcome Measures and Open PROM Availability to Treating Neurologist Highlights & Side Effects. Trial Name: NCT04979546 — N/A

Intensive Use of Patient Reported Outcome Measures and Open PROM Availability to Treating Neurologist 2023 Treatment Timeline for Medical Study. Trial Name: NCT04979546 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the central aims of this medical research?

"The primary outcome of this trial, evaluated over a 12-month period, is the alteration in Hospital Anxiety and Depression Scale (HADS-A) scores. Secondary objectives include modification to Modified Fatigue Impact Scale (MFIS), changes in the CollaboRATE shared decision-making survey outcomes, and fluctuation of Patient Health Questionnaire-9 (PHQ-9) indices."

Answered by AI

What is the magnitude of subjects currently participating in this clinical investigation?

"Affirmative. Clinicaltrials.gov corroborates that this investigation is currently recruiting; it was initially listed on November 4th 2021 and lastly revised on November 1st 2022. 356 participants are required for the study, with recruitment taking place at just one site."

Answered by AI

Is the current research study open to recruitment?

"The data published on clinicaltrials.gov indicates that this research is currently accepting participants. It was first posted to the public domain on November 4th 2021 and its most recent amendment occurred on November 1st 2022."

Answered by AI