Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04975685 |
| Other study ID # |
21002 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 7, 2022 |
| Est. completion date |
April 30, 2024 |
Study information
| Verified date |
November 2023 |
| Source |
University of Lincoln |
| Contact |
Alexandra Frost |
| Phone |
07811474337 |
| Email |
alexandra.frost[@]nottshc.nhs.uk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Background: Multiple Sclerosis (MS) is a chronic condition of the central nervous system;
around 1 in 600 people in the United Kingdom have MS. Many people with MS (70%) have
cognitive difficulties, which they experience as distressing and disabling, and there is
currently a lack of treatment options to improve these difficulties.
SMART (Strengthening Mental Abilities with Relational Training) - a theory-based online
cognitive training programme, which has been shown to improve general cognitive abilities -
has not been tested with people who have MS.
Aims: To conduct a feasibility study to inform development of a definitive trial of SMART for
improving cognitive functioning in people with MS. The investigators will assess:
1. Acceptability to participants of the intervention, delivery format, inclusion/exclusion
criteria, baseline and outcome measures, randomisation protocol, and study procedures
2. The framework for a cost-effectiveness analysis alongside a definitive trial
3. Participant recruitment and retention rates
4. Sample-size needed for fully powered trial
5. Signal of efficacy
Plan: To address Aims 1-5, the investigators will recruit 60 adults with MS who are
experiencing cognitive difficulties, identified from MS clinics.
Participants will complete baseline assessments of their cognitive abilities and answer
questionnaires about their cognitive difficulties, personal priorities, mood, fatigue,
self-efficacy, quality of life, and healthcare services used.
Assessments will be administered by a researcher, face-to-face or remotely.
Participants will be randomly allocated to one of three arms (20 per group):
Group 1: Receives SMART intervention online - plus usual care (MS Nurse support). SMART
intervention involves completing a series of logic problems, which are designed to train
skills that scaffold complex cognition.
Group 2: Receives usual care alone. Group 3: Receives a 'control' intervention online - plus
usual care.
Baseline measures will be re-administered at three- and six-months post-randomisation.
Researchers and patient-partners (people with personal experience of MS, who will act as
co-researchers) will also interview 30 participants about their experience of the study and
treatment. All qualitative data will be transcribed and thematically analysed in terms of a
priori feasibility aims. Quantitative data will enable sample-size calculation for a
definitive study and determine signal of efficacy.
Description:
Background:
Cognitive deficits have been identified as the most debilitating impact of MS. These deficits
interfere with daily living, manifesting as inattention (e.g., getting easily distracted),
forgetting (e.g., leaving the stove on after cooking), and problem-solving difficulties
(e.g., getting confused when completing a multi-stage task like cooking). The burden of these
deficits reduces quality of life and restricts daily activities and employment - and
correspondingly, diminishes patient perceptions of personal competence and self-worth.
Cognitive rehabilitation is not routinely offered in the National Health Service (NHS) - and,
when it is offered, largely focuses on teaching people to compensate for deficits (e.g.,
using external memory aids) rather than retraining cognitive skills. A recent
state-of-the-field review from international MS experts has called for research towards
identifying effective, evidence-based, and clinically feasible interventions to address
cognitive deficits in MS. There is evident uncertainty about how to intervene effectively,
and this is recognised by the James Lind Alliance as a top-10 priority area for
research-funding.
Our trial tests the feasibility of a highly accessible and low-resource format of cognitive
rehabilitation (online training). Given NHS resource constraints, the scale of the problem,
and concerns about face-to-face consultation in the context of COVID-19, new and
cost-effective ways of implementing promising cognitive rehabilitation interventions are
needed. Low-resource online formats are more likely to be implemented if found to be
clinically effective, enable wider access for patients, and provide active support for
self-management - consistent with (1) models of care for managing longer-term conditions and
(2) the digital healthcare agenda.
As a feasibility trial, outcomes are unlikely to immediately effect changes to NHS practice.
However, this is a necessary step towards developing a definitive trial - and will give us a
signal of efficacy, a prerequisite for progression to a definitive trial. If found to be
clinically- and cost-effective, the latter trial could create a step-change in MS cognitive
rehabilitation - improving service-delivery and optimising support with limited additional
resources.
Aim:
To conduct a feasibility study to inform development of a definitive trial of SMART (an
online 'brain training' treatment) for improving cognitive functioning in people with MS.
The investigators will assess:
1. Acceptability to participants of the intervention, delivery format, inclusion/exclusion
criteria, baseline and outcome measures, randomisation protocol, and study procedures
2. The framework for a cost-effectiveness analysis alongside a definitive trial
3. Participant recruitment and retention rates
4. Sample-size needed for fully powered trial
5. Signal of efficacy
Research plan:
The investigators will conduct a three-arm feasibility Randomised Controlled Trial (RCT)
comparing (1) SMART + treatment-as-usual (TAU) with (2) TAU and (3) active control ('sham')
training + TAU.
Consenting eligible patients will complete a baseline cognitive assessment battery and
questionnaires assessing impact of living with MS, health-related quality of life, subjective
cognitive difficulties, and service/resource-use.
After completing baseline assessments, participants will be randomly allocated to one of
three arms (using minimisation to balance participant characteristics across arms):
1. SMART + TAU
2. TAU. Content of TAU for cognitive concerns, based on our clinical experience and
knowledge, is often informational support from an MS Nurse with signposting to the MS
Society/MS Trust websites.
3. Sham training (active control: Sudoku) + TAU. The investigators selected Sudoku to
control for expectancy effects based on popular conceptions that it broadly improves
cognitive functions, coupled with little evidence supporting this notion, and its use as
an active control in similar trials. Sham-training will be delivered online, over the
same timeframe/regimen as SMART treatment, and with telephone support to facilitate
access - controlling for modality, schedule of engagement, and relational support.
A Research Fellow will complete blinded outcomes at 3- and 6-months post-randomisation, by
re-administering baseline measures. Quantitative data will enable sample-size calculation for
a definitive study and determine signal of efficacy. After the first follow-up assessment (>3
months post-randomisation) a sub-sample of participants will engage in feasibility-feedback
interviews.
