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

Abstract

Background: Cognitive difficulties experienced by people with multiple sclerosis (MS) impact their quality of life and daily functioning, from childcare and work, to social and self-care activities. Despite the high prevalence of cognitive difficulties seen in MS, there is a lack of developed programmes that target cognition, while also supporting patients by helping them to function well in everyday life. The Cognitive Occupation-Based programme for people with MS (COB-MS) was developed as a holistic, individualised cognitive rehabilitation intervention. It addresses 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 current research is to evaluate the feasibility and preliminary efficacy of COB-MS for people with MS. The focus is on feasibility outcomes as well as functioning associated with cognitive difficulty and secondary outcomes related to cognition, fatigue and quality of life. Methods: 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 primary outcome measure is the goal attainment scaling at 12 weeks. Participants will be assessed pre-intervention, post-intervention and at 12 weeks post-intervention and 6 months post-intervention. Qualitative evaluations of participants' perspectives will also be examined as part of the feasibility study. Discussion: Results will provide recommendations for a future definitive trial of COB-MS, with respect to both feasibility and preliminary, clinical efficacy. In the event that results indicate efficacy, study findings will suggest that COB-MS requires consideration as a means of enhancing cognitive and daily functioning in people living with MS.

A qualitative investigation of reasoning behind decisions to decline participation in a research intervention: A study-within-a-trial

“…The qualitative SWAT took place within the context of a RCT of a Cognitive, Occupation-Based programme for people with Multiple Sclerosis ( Dwyer et al, 2020 ) – from here on referred to as the host trial, which is a single-blind, cluster-randomised controlled feasibility trial, using a two-arm (i.e. treatment and wait-list controls), pre-post study design and two additional follow-up testing times (i.e.…”

“…Also noteworthy is that potential participants were provided one of two possible participant information sheets (see Online Supplemental Material ), both of which included all information pertinent to study procedures, informed consent and mainly differed with respect to formatting and wording. This design manipulation was implemented consistent with the aims of another one of the host trial’s SWATs, which was to compare the effects of two patient information sheets (PISs): a patient-designed-and-informed PIS and a standard, researcher-designed PIS on: recruitment, decision certainty, retention; understanding, readability, accessibility, likeability and decision to consent ( Dwyer et al, 2020 ). As a result, all individuals expressing interest in the host trial had a 50% chance of receiving the patient-developed PIS or the researcher-developed PIS.…”

Comparing the effects of a patient-designed-and-informed participant information leaflet in comparison with a standard, researcher-designed information leaflet on recruitment, retention and understanding: A study-within-a-trial

“…A SWAT is a self-contained research study embedded within a host trial for the purpose of investigating or evaluating trial processes and/or alternatives [ 18 ]. The SWAT was part of a larger, single-blind, cluster-randomised controlled feasibility and preliminary efficacy trial of the Cognitive Occupation-Based programme for people living with Multiple Sclerosis (COB-MS) [ 19 ], from here on referred to as ‘the host trial’. This SWAT was a double-blind, randomised trial comparing the effects of a patient-designed-and-informed PIL with a standard, researcher-designed PIL.…”

“…The sample size was felt that it would be large enough to inform them about the practicalities of a definitive randomised trial, allowing for attrition rate of 9%. The SWAT sample size was dependent on the host trial (COB-MS), therefore no formal sample size calculation was performed, which is in line with SWAT methodology [ 19 , 29 ]. SWAT sample size was the same as that for the host trial- n = 100.…”

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

“…This update describes the amendments made (and approved by the Research Ethics Committee) to a study due to the impact of the COVID-19 pandemic. This update should be read in conjunction with the original published protocol [1].…”