FIT-Participation-MND
Research type
Research Study
Full title
Factors Influencing Trial Participation in People with Motor Neurone Disease
IRAS ID
276016
Contact name
Suvankar Pal
Contact email
Sponsor organisation
The University of Edinburgh
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
Research Summary
The purpose of this study is to improve our understanding of why people with a diagnosis of motor neurone disease (MND) choose to participate, or not participate, in clinical trials of potential new drugs. We will also look why individuals with MND who are participating in a clinical trial may stop participating in that trial.\nIndividuals do not have to be participating in a clinical trial to be involved in this study. \nThis study will better inform research as to potential barriers experienced by people for participating, and remaining, in a clinical trial. Improving our understanding of these factors will enable us to change trial designs to be more inclusive and identify participants who may be ‘high-risk’ and need more support from the research team to remain in a clinical trial.\nTo participate in this study people with MND will be required to complete a brief set of questionnaires that should take around 45 minutes to complete. Participants will also be required to identify carer/relative to complete a short, 5 minute, questionnaire about behaviour. These questionnaires can be posted to participants, completed online, over the telephone with the research team or combined with research/clinical appointments at the Anne Rowling Regenerative Neurology Clinic. \nWe will also use data from the participants’ records on CARE-MND (Clinical, Audit, Research and Evaluation in Motor Neurone Disease) that are collected in routine clinical care.\nFinally, we will link this data to data on participation in MND-SMART (Motor Neurone Disease Systematic Adaptive Randomised Trial). MND-SMART is a clinical trial of drugs which may help people with MND; it will begin recruitment in March 2020. \nWe will look at how many participants in this study go on to become participants in MND-SMART, and how many of them remain in the clinical trial after 12 months.
Summary of Results
The purpose of this study was to improve understanding of why people with MND choose to participate, or not, in clinical trials of potential new drugs. It also looked at why individuals with MND who are participating in a clinical trial may stop participating in that trial.
The findings from this study aim to better inform research as to potential barriers experienced by people for participating, and remaining, in a clinical trial. Improving understanding of these factors may inform future trial protocol designs to be more inclusive and identify participants who may be ‘high-risk’ and need more support from the research team to remain in a clinical trial.
There is already evidence to support how ‘trial factors’ such as the design of a clinical trial, inclusion/exclusion criteria and method of patient follow-up can affect how successful a trial in MND is at recruiting and retaining participants.
MND-SMART is an innovative new multi-arm adaptive trial co-produced alongside people living with MND which addresses many of these ‘trial factors’ and provides an excellent opportunity to study how ‘person-specific factors’ may also impact upon how likely people with MND are to get involved in, and stay in, clinical trials.
Participants completed structured questionnaires and the project involved linking these to clinical records on the Scottish MND register, CARE-MND, and the participants’ involvement in MND-SMART.
This study investigated the presence of psychiatric symptoms (particularly depression and anxiety), apathy, cognitive impairment, self-reported quality of life, health perception, functional ability and medical history in a sample of people with MND. It evaluated how many of the individuals from the cohort participated in the MND-SMART trial, and if they remained in the trial 12 months later.
Of 120 participants, 50% also joined MND-SMART, and 33% of the FIT-P-MND participants remained in the clinical trial after one year. The study identified that people were less likely to get involved in MND-SMART, and to stay participating, if they were older in age and experienced apathy (a behavioural change that can affect some people with MND meaning that they have difficulty with motivation).REC name
West of Scotland REC 3
REC reference
20/WS/0067
Date of REC Opinion
29 Apr 2020
REC opinion
Favourable Opinion