The Effect of Nurse Practitioner (NP-led) Care Upon Mood in People Wit
MS Wellness Navigator: The Effect of Nurse Practitioner (NP-led) Care on Mood, Anxiety and Health Related Quality of Life in People With Multiple Sclerosis - A Randomized Trial
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Nurse Practitioner (NP) Led Care Arm
What it measured
Main measures
Difference in Change in Hospital Anxiety & Depression Scale - Depression (HADS-D) and Hospital Anxiety & Depression Scale-Anxiety (HADS-A) scores
3 months
Mood and sleep
Other measures (6)
Difference in Change in Hospital Anxiety & Depression Scale - Depression (HADS-D) and Hospital Anxiety & Depression Scale-Anxiety (HADS-A) scores
6 months
Mood and sleepDifference in Change in Euro Quality of Life Measurement (EQ5D)
3 and 6 months
Walking and mobilityPainMood and sleepQuality of life (reported by participants)Difference in Change Modified Fatigue Impact Scale (MFIS) score
3 and 6 months
Thinking and memoryFatigueQualitative Consultant Satisfaction Questionnaire (CSQ)
6 months
Quality of life (reported by participants)Difference in Change in Caregiver Health-Related Quality of Life in MS (CAREQOL-MS)
3 and 6 months
Quality of life (reported by participants)Number of Participant Outpatient Healthcare Interactions/Visits
3 and 6 months
Who could take part
MS (type not specified) · 18 and over · EDSS 3.0 to 8.5
Show the full criteria
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
The effect of nurse practitioner (NP-led) care on health-related quality of life in people with multiple sclerosis - a randomized trial.BMC Neurol · 2022
Background
Amankwah N, Marrie RA, Bancej C, Garner R, Manuel DG, Wall R, Fines P, Bernier J, Tu K, Reimer K. Multiple sclerosis in Canada 2011 to 2031: results of a microsimulation modelling study of epidemiological and economic impacts. Health Promot Chronic Dis Prev Can. 2017 Feb;37(2):37-48. doi: 10.24095/hpcdp.37.2.02.Background
Baker R. Development of a questionnaire to assess patients' satisfaction with consultations in general practice. Br J Gen Pract. 1990 Dec;40(341):487-90.Background
Benito-Leon J, Rivera-Navarro J, Guerrero AL, de Las Heras V, Balseiro J, Rodriguez E, Bello M, Martinez-Martin P; caregiver quality of life in multiple sclerosis (CAREQOL-MS) Study Group. The CAREQOL-MS was a useful instrument to measure caregiver quality of life in multiple sclerosis. J Clin Epidemiol. 2011 Jun;64(6):675-86. doi: 10.1016/j.jclinepi.2010.08.003. Epub 2010 Nov 11.Background
Borreani C, Bianchi E, Pietrolongo E, Rossi I, Cilia S, Giuntoli M, Giordano A, Confalonieri P, Lugaresi A, Patti F, Grasso MG, de Carvalho LL, Palmisano L, Zaratin P, Battaglia MA, Solari A; PeNSAMI project. Unmet needs of people with severe multiple sclerosis and their carers: qualitative findings for a home-based intervention. PLoS One. 2014 Oct 6;9(10):e109679. doi: 10.1371/journal.pone.010967Background
Broderick JE, Keefe FJ, Bruckenthal P, Junghaenel DU, Schneider S, Schwartz JE, Kaell AT, Caldwell DS, McKee D, Reed S, Gould E. Nurse practitioners can effectively deliver pain coping skills training to osteoarthritis patients with chronic pain: A randomized, controlled trial. Pain. 2014 Sep;155(9):1743-1754. doi: 10.1016/j.pain.2014.05.024. Epub 2014 May 24.Background
Buchanan RJ, Radin D, Huang C. Caregiver burden among informal caregivers assisting people with multiple sclerosis. Int J MS Care. 2011 Summer;13(2):76-83. doi: 10.7224/1537-2073-13.2.76.Background
GBD 2016 Neurology Collaborators. Global, regional, and national burden of neurological disorders, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019 May;18(5):459-480. doi: 10.1016/S1474-4422(18)30499-X. Epub 2019 Mar 14.Background
Fiest KM, Walker JR, Bernstein CN, Graff LA, Zarychanski R, Abou-Setta AM, Patten SB, Sareen J, Bolton JM, Marriott JJ, Fisk JD, Singer A, Marrie RA; CIHR Team Defining the Burden and Managing the Effects of Psychiatric Comorbidity in Chronic Immunoinflammatory Disease. Systematic review and meta-analysis of interventions for depression and anxiety in persons with multiple sclerosis. Mult Scler ReBackground
Fisk JD, Pontefract A, Ritvo PG, Archibald CJ, Murray TJ. The impact of fatigue on patients with multiple sclerosis. Can J Neurol Sci. 1994 Feb;21(1):9-14.
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History
Started
Apr 2017
Main results due
Apr 2019
Finished
Nov 2019