The Effect of Nurse Practitioner (NP-led) Care Upon Mood in People With Multiple Sclerosis (NCT04388592) | Clinical Trial Compass
CompletedNot Applicable
The Effect of Nurse Practitioner (NP-led) Care Upon Mood in People With Multiple Sclerosis
Canada248 participantsStarted 2017-04-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* \>/= 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
* Initially, we limited inclusion to those who are experiencing disability from their MS (Expanded Disability status Scale (EDSS) 3.0 to 8.5 . In 2018, due to poor recruitment, the inclusion criteria were opened to include any PwMS and was not limited to disability level.
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Difference in Change in Hospital Anxiety & Depression Scale - Depression (HADS-D) and Hospital Anxiety & Depression Scale-Anxiety (HADS-A) scores