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The Effect of Nurse Practitioner (NP-led) Care Upon Mood in People With Multiple Sclerosis

NCT04388592 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 248

Last updated 2024-09-19

No results posted yet for this study

Summary

MS is the leading cause of non-traumatic disability in young adults. Canada and Alberta, have the highest prevalence of people with multiple sclerosis (PwMS) in the world. To keep PwMS as functional as possible, a multi-disciplinary team is considered essential in the approach to treating people with MS. Because of the high numbers of PwMS in Northern Alberta, private-practice general neurologists provide care to a large number of PwMS outside of a multi-disciplinary tertiary care setting. It is challenging for these general neurologists with busy office practices to deliver optimal care to PwMS who have high care needs. The investigators wish to evaluate the effects of nurse practitioner (NP) led care for PwMS on their depression and anxiety levels at 3 and 6 months compared to "usual care' (community neurologists and MS registered nurses) in addition to measuring quality of life for PwMS and their caregivers, fatigue levels, monitor their outpatient healthcare usage and patient's satisfaction of care provided. The investigators wish to conduct a prospective randomized controlled trial examining NP intervention care for PwMS. It is hypothesized that PwMS whose care is managed by an NP will have less depression and anxiety (as measured by the Hospital Anxiety and Depression Scale - HADS) at 3 months.

Conditions

  • Multiple Sclerosis
  • Nurse's Role

Interventions

OTHER

Nurse Practitioner (NP) Led Care Arm

The NP will conduct baseline consultation visits with the participants and their caregivers (if applicable). They will then initiate treatment for the participant's symptoms as appropriate (ie: depression treatment for depressive symptoms, fatigue management strategies), connect to resources in the community as needed (ie: rehabilitation programs, home care support, psychologist support) to optimize functioning. There will be scheduled follow visits and/or phone calls with the NP at 3 and 6 months.

Sponsors & Collaborators

  • University Hospital Foundation

    collaborator OTHER

  • University of Alberta

    lead OTHER

Principal Investigators

  • Penelope Smyth, MD, FRCPC · University of Alberta

  • Ross Tsuyuki, PharmD, MSc · University of Alberta

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-01
Primary Completion
2019-04-30
Completion
2019-11-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04388592 on ClinicalTrials.gov