Neuropsychological evaluation and rehabilitation in multiple sclerosis (NEuRoMS): protocol for a mixed-methods, multicentre feasibility randomised controlled trial.
Cognition
Cognitive screening
Feasibility study
Multiple sclerosis
Randomised controlled trial
Rehabilitation
Journal
Pilot and feasibility studies
ISSN: 2055-5784
Titre abrégé: Pilot Feasibility Stud
Pays: England
ID NLM: 101676536
Informations de publication
Date de publication:
11 Jun 2022
11 Jun 2022
Historique:
received:
13
11
2021
accepted:
17
05
2022
entrez:
11
6
2022
pubmed:
12
6
2022
medline:
12
6
2022
Statut:
epublish
Résumé
Cognitive problems affect up to 70% of people with multiple sclerosis (MS), which can negatively impact mood, ability to work, and quality of life. Addressing cognitive problems is a top 10 research priority for people with MS. Our ongoing research has systematically developed a cognitive screening and management pathway (NEuRoMS) tailored for people with MS, involving a brief cognitive evaluation and rehabilitation intervention. The present study aims to assess the feasibility of delivering the pathway and will inform the design of a definitive randomised controlled trial (RCT) to investigate the clinical and cost-effectiveness of the intervention and eventually guide its clinical implementation. The feasibility study is in three parts. Part 1 involves an observational study of those who receive screening and support for cognitive problems, using routinely collected clinical data. Part 2 is a two-arm, parallel group, multicentre, feasibility RCT with a nested fidelity evaluation. This part will evaluate the feasibility of undertaking a definitive trial comparing the NEuRoMS intervention plus usual care to usual care only, amongst people with MS with mild cognitive problems (n = 60). In part 3, semi-structured interviews will be undertaken with participants from part 2 (n = 25), clinicians (n = 9), and intervention providers (n = 3) involved in delivering the NEuRoMS cognitive screening and management pathway. MS participants will be recruited from outpatient clinics at three UK National Health Service hospitals. Timely screening and effective management of cognitive problems in MS are urgently needed due to the detrimental consequences of cognitive problems on people with MS, the healthcare system, and wider society. The NEuRoMS intervention is based on previous and extant literature and has been co-constructed with relevant stakeholders. If effective, the NEuRoMS pathway will facilitate timely identification and management of cognitive problems in people with MS. ISRCTN11203922 . Prospectively registered on 09.02.2021.
Sections du résumé
BACKGROUND
BACKGROUND
Cognitive problems affect up to 70% of people with multiple sclerosis (MS), which can negatively impact mood, ability to work, and quality of life. Addressing cognitive problems is a top 10 research priority for people with MS. Our ongoing research has systematically developed a cognitive screening and management pathway (NEuRoMS) tailored for people with MS, involving a brief cognitive evaluation and rehabilitation intervention. The present study aims to assess the feasibility of delivering the pathway and will inform the design of a definitive randomised controlled trial (RCT) to investigate the clinical and cost-effectiveness of the intervention and eventually guide its clinical implementation.
METHODS
METHODS
The feasibility study is in three parts. Part 1 involves an observational study of those who receive screening and support for cognitive problems, using routinely collected clinical data. Part 2 is a two-arm, parallel group, multicentre, feasibility RCT with a nested fidelity evaluation. This part will evaluate the feasibility of undertaking a definitive trial comparing the NEuRoMS intervention plus usual care to usual care only, amongst people with MS with mild cognitive problems (n = 60). In part 3, semi-structured interviews will be undertaken with participants from part 2 (n = 25), clinicians (n = 9), and intervention providers (n = 3) involved in delivering the NEuRoMS cognitive screening and management pathway. MS participants will be recruited from outpatient clinics at three UK National Health Service hospitals.
DISCUSSION
CONCLUSIONS
Timely screening and effective management of cognitive problems in MS are urgently needed due to the detrimental consequences of cognitive problems on people with MS, the healthcare system, and wider society. The NEuRoMS intervention is based on previous and extant literature and has been co-constructed with relevant stakeholders. If effective, the NEuRoMS pathway will facilitate timely identification and management of cognitive problems in people with MS.
TRIAL REGISTRATION
BACKGROUND
ISRCTN11203922 . Prospectively registered on 09.02.2021.
Identifiants
pubmed: 35690797
doi: 10.1186/s40814-022-01073-5
pii: 10.1186/s40814-022-01073-5
pmc: PMC9187894
doi:
Types de publication
Journal Article
Langues
eng
Pagination
123Subventions
Organisme : National Institute for Health Research
ID : RP-PG-0218-20002
Informations de copyright
© 2022. The Author(s).
Références
Lancet Neurol. 2008 Dec;7(12):1139-51
pubmed: 19007738
Mult Scler Relat Disord. 2021 Apr;49:102563
pubmed: 33677366
J Med Internet Res. 2020 Sep 23;22(9):e18234
pubmed: 32965240
Mult Scler. 2018 Nov;24(13):1665-1680
pubmed: 30303036
Qual Life Res. 2011 Dec;20(10):1727-36
pubmed: 21479777
Brain. 2001 May;124(Pt 5):962-73
pubmed: 11335698
Stat Med. 2011 Apr 30;30(9):922-34
pubmed: 21284014
Neuropsychol Rehabil. 2021 May 3;:1-19
pubmed: 33941045
Mult Scler. 2019 Nov;25(13):1809-1818
pubmed: 30381987
Neurology. 1991 May;41(5):692-6
pubmed: 1823781
J Neurovirol. 2000 May;6 Suppl 2:S186-90
pubmed: 10871811
J Gen Intern Med. 1997 Jul;12(7):439-45
pubmed: 9229283
BMC Med Res Methodol. 2013 Jun 13;13:78
pubmed: 23758922
Int J Clin Pract. 2018 Dec 3;:e13300
pubmed: 30507025
Disabil Rehabil. 2014;36(8):635-41
pubmed: 23786346
Arch Intern Med. 2006 May 22;166(10):1092-7
pubmed: 16717171
Appl Health Econ Health Policy. 2013 Jun;11(3):155-61
pubmed: 23529715
Eur J Neurol. 2011 Jan;18(1):69-77
pubmed: 20561039
BMJ Open. 2017 Feb 17;7(2):e013537
pubmed: 28213598
Qual Life Res. 2012 Feb;21(1):167-76
pubmed: 21598064
Health Technol Assess. 2020 Jan;24(4):1-182
pubmed: 31934845
Mult Scler Relat Disord. 2016 Sep;9 Suppl 1:S5-S48
pubmed: 27640924
BMJ Open. 2021 Jun 16;11(6):e048788
pubmed: 34135052
Mult Scler. 2003 Feb;9(1):73-81
pubmed: 12617272
Mult Scler Relat Disord. 2020 Feb;38:101479
pubmed: 31760365
Int J Nurs Stud. 2013 May;50(5):587-92
pubmed: 23159157
Implement Sci. 2007 Nov 30;2:40
pubmed: 18053122
BMJ. 2000 Jan 8;320(7227):114-6
pubmed: 10625273
J Neurol Sci. 2014 Aug 15;343(1-2):91-9
pubmed: 24950898
Mult Scler. 2002 Oct;8(5):372-6
pubmed: 12356202
Cochrane Database Syst Rev. 2021 Oct 18;10:CD008754
pubmed: 34661282
J Public Health Dent. 2011 Winter;71(s1):S52-S63
pubmed: 21499543
JAMA Neurol. 2021 Apr 1;78(4):414-425
pubmed: 33393981
Neurology. 2018 Feb 6;90(6):278-288
pubmed: 29343470
J Gen Intern Med. 2001 Sep;16(9):606-13
pubmed: 11556941