Evidence map›Paper›PMID 36670485›Full record

ArticleTrials2023

Evaluating the feasibility and preliminary efficacy of a Cognitive Occupation-Based programme for people with Multiple Sclerosis (COB-MS): an update to the protocol for a feasibility cluster-randomised controlled trial.

Christopher P Dwyer, Alberto Alvarez-Iglesias, Robert Joyce, Timothy J Counihan, Dympna Casey, Sinéad M Hynes

Abstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. A cluster-randomised controlled feasibility trial evaluating the Cognitive Occupation-Based programme for people with Multiple Sclerosis (COB-MS).Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2025
    Trial
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Christopher P DwyerDiscipline of Occupational Therapy, School of Health Sciences, National University of Ireland Galway, Galway, Ireland.
Alberto Alvarez-IglesiasHealth Research Board Clinical Research Facility, National University of Ireland Galway, Galway, Ireland.
Robert JoyceDiscipline of Occupational Therapy, School of Health Sciences, National University of Ireland Galway, Galway, Ireland.
Timothy J CounihanDepartment of Neurology, University Hospital Galway, Galway, Ireland.
Dympna CaseyQualitative Research Trials Centre (QUESTS), School of Nursing & Midwifery, National University of Ireland Galway, Galway, Ireland.
Sinéad M HynesDiscipline of Occupational Therapy, School of Health Sciences, National University of Ireland Galway, Galway, Ireland. sinead.hynes@nuigalway.ie.ORCID http://orcid.org/0000-0002-3199-7355

Funding

Health Research Board DIFA-FA-2018-027Higher Education Authority COVID-19 Related Research Costed Extension
6 · The paper itself

Abstract

backgroundCognitive difficulties experienced by people with multiple sclerosis (MS) impact on quality of life and daily functioning, from childcare and work to social and self-care activities. The Cognitive Occupation-Based programme for people with MS (COB-MS) was developed as a holistic, individualised cognitive rehabilitation intervention to address the wide-ranging symptoms and functional difficulties that present in MS, including the ability to maintain employment, social activities, home management and self-care. The aim of the research is to evaluate the feasibility and preliminary efficacy of COB-MS for people with MS.

methodsDue to the impacts of COVID-19, trial activities that were planned for in-person delivery were completed remotely. One hundred and twenty people with MS will be assigned to participate in either the COB-MS programme or a treatment-as-usual, wait-list control group as part of this single-blind, cluster-randomised controlled feasibility and preliminary efficacy trial of the COB-MS programme. The COB-MS group will participate in an eight-session occupational-based cognitive rehabilitation programme over 9 weeks. The COB-MS intervention was planned for in-person delivery but was delivered online by occupational therapists to small groups of people with MS. The primary outcome measure is the Goal Attainment Scaling at 12 weeks. Participants will be assessed pre-intervention, post-intervention, 12 weeks post-intervention and 6 months post-intervention. Qualitative evaluations of participants' perspectives will also be examined as part of the feasibility study. Data, due to be collected in-person, was collected online or by post. The original study design, including the statistical analysis plan, remains unchanged despite the shift to a remote trial conduct. DISCUSSION: Results will provide recommendations for a future definitive trial of COB-MS, with respect to both feasibility and preliminary, clinical efficacy.

trial registrationISRCTN ISRCTN11462710 . Registered on 9 September 2019 and updated on 23 September 2020 to account for changes outlined here.

Indexed as

COVID-19Multiple SclerosisCognitionFeasibility StudiesHumansOccupationsQuality of LifeRandomized Controlled Trials as TopicSingle-Blind MethodCognitive Occupation-Based programmeCognitive rehabilitationFeasibilityMultiple sclerosisOccupational therapyProtocol

Identifiers

PMID36670485
PMCPMC9854022

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.