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

NCT04388592 | Completed

• 1 other identifier: Pro00069595
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

multiple sclerosis; nurse's role; depression and anxiety; quality of life; patient satisfaction

Outcome Measures

Primary Outcomes (1)

• Difference in Change in Hospital Anxiety & Depression Scale - Depression (HADS-D) and Hospital Anxiety & Depression Scale-Anxiety (HADS-A) scores

  Hospital Anxiety \& Depression Scale (D subcategory for depression levels, A subcategory for anxiety levels). This is a common depression and anxiety measurement instrument used in multiple sclerosis. Minimum score is 0, and maximum score is 21. Higher scores indicate worse outcome. Three papers report total HADS scores in PwMS. Using the information from Honarmand and Feinstein \[Baseline scores and standard deviation (SD)\] and the following assumptions 90% power and a two-sided alpha of 0.05, a total sample size of 200 (100 in each group) was required to detect 1.5 difference between the intervention and the control groups. This sample size was inflated to 220 to account for possible dropouts, losses to follow-up and withdrawals of consent.

  3 months

Secondary Outcomes (6)

• Difference in Change in Hospital Anxiety & Depression Scale - Depression (HADS-D) and Hospital Anxiety & Depression Scale-Anxiety (HADS-A) scores

  6 months

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

  3 and 6 months

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

  3 and 6 months

• Qualitative Consultant Satisfaction Questionnaire (CSQ)

  6 months

• Difference in Change in Caregiver Health-Related Quality of Life in MS (CAREQOL-MS)

  3 and 6 months

Study Arms (2)

Nurse practitioner (NP)-led care arm

EXPERIMENTAL

The patient randomized to the NP intervention arm will be contacted by the NP to be scheduled for an NP appointment within 4 to 6 weeks from the date of the referral. The NP consultation will include patient history, physical examination, symptomatic management strategies as appropriate (eg: bladder and bowel management strategies, fatigue management, depression, anxiety, spasticity etc), discussion of mental and physical health resources for symptomatic treatment, support, physical and mental health resources to optimize functioning (eg: home care, physical/occupational therapy referral) and quality of life. There will be NP followup, in person or by phone or videoconferencing at 3 months, and 6 months. The NP will be using the electronic medical record offered by Alberta Health Services.

Other: Nurse Practitioner (NP) Led Care Arm

Usual Care Arm

NO INTERVENTION

Those patients randomized to the usual care arm (community neurologist and registered nurses) will be contacted by the NP to be scheduled for an NP appointment in 6 months, so that every participant is given the opportunity to meet with the NP, after their involvement in the study has concluded. During the six-month period, patients randomized to the control group will receive usual care from community neurologists and MS registered nurses or family physicians. The care will be delivered according to standard practices, and follow-up visits will be conducted according to the various neurologists' or family physicians' practices.

Interventions

Nurse Practitioner (NP) Led Care Arm OTHER

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.

Nurse practitioner (NP)-led care arm

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participants are enrolled as how they report themselves to be.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>/= 18 years of age
• a MS diagnosis (by 2010 MacDonald MS criteria (Polman et al 2011)
• Followed by a private-practice general neurologist and/or family doctor in the Northern Alberta region
• Willingness to give consent
• Ability to complete questionnaires
• Willingness to attend outpatient visits with NP
• English-speaking
• Were able to use a computer

You may not qualify if:

• Under the age of 18 years old
• Unable to provide consent
• Unable to attend appointments with the NP
• Did not speak English
• Referred to or followed by neurologists within the tertiary University MS clinic setting
• Those who had central nervous system inflammatory disorders other than MS

Sponsors & Collaborators

• University of Alberta: lead
• University Hospital Foundation: collaborator

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2R3, Canada

Location

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MeSH Terms

Conditions

Multiple Sclerosis; Depression; Anxiety Disorders; Patient Satisfaction

Interventions

Nurse Practitioners

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavioral Symptoms; Behavior; Mental Disorders; Treatment Adherence and Compliance; Health Behavior

Intervention Hierarchy (Ancestors)

Nurses; Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• Penelope Smyth, MD, FRCPC

  University of Alberta

  PRINCIPAL INVESTIGATOR

• Ross Tsuyuki, PharmD, MSc

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The research team will randomize consented patients who meet inclusion criteria on a 1:1 ratio on a centralized secure website. Block randomization (using variable block sizes) will be used to ensure there are equal participants in the intervention and control arms and to further conceal allocation. Participants will be randomized to either the intervention group of NP-led care or the control group of standard care provided by community neurologist and registered nurse. Due to the nature of the intervention, blinding of the providers or patients will not be possible. However, the statistician will be blinded as to which group represents the intervention and control. All participants will be given appointment with the NP, either within 4 to 6 weeks if randomized to the intervention arm, or at 6 months after study conclusion if in usual care arm.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A parallel prospective randomized controlled trial with two equal groups, testing for superiority, with the patient as the unit of randomization.

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: May 14, 2020
• Study Start: April 1, 2017
• Primary Completion: April 30, 2019
• Study Completion: November 30, 2019
• Last Updated: September 19, 2024

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)