The PrEliMS Feasibility Trial
Research type
Research Study
Full title
Providing Emotional Support Around the Point of Multiple Sclerosis Diagnosis (PrEliMS): A Feasibility Randomised Controlled Trial
IRAS ID
250799
Contact name
Roshan das Nair
Contact email
Sponsor organisation
University of Nottingham
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
1 years, 5 months, 29 days
Research summary
Research Summary
Based on research evidence and stakeholder input (people with multiple sclerosis [MS], families/carers, health professionals, charity staff and volunteers), we developed a point of diagnosis intervention to provide emotional support for newly diagnosed people with MS. If the intervention is effective, patients may experience improved mood and quality of life, and more confidence in their ability to cope with the diagnosis and associated emotional demands.
This feasibility study will enable us to plan for a definitive trial to evaluate the effectiveness of this point of diagnosis intervention. The aim is to evaluate the suitability of the trial procedures and intervention, and enable us to calculate the number of people needed for a definitive study. Potential participants will be people who have been recently diagnosed with MS (or currently going through diagnosis process), and who are aged 18 years or over, recruited through MS clinics. Participants, after consent, will complete baseline measures before being allocated to one of three groups by chance (randomisation). Group 1 (20 patients) will not receive any intervention. Group 2 (20 patients) will receive the ‘Enhanced MS Nurse Support’ which will include one face-to-face session delivered by an MS Nurse. Group 3 (20 patients) will receive the ‘Enhanced MS Nurse Support’ plus ‘Peer Support’ (Peer Support will include a minimum of two face-to-face session delivered by Peer Support Workers [patients with lived experiences]). All groups will receive usual care. The same assessments will be repeated 3 and 6 months after randomisation by all participants. Feedback interviews with some participants will be conducted to assess what parts of the intervention were helpful or unhelpful, the acceptability of randomisation and trial procedures, and the appropriateness of the measures used. Participants will be in the study for approximately 6 months and the study will last 18 months.
Summary of Results
Forty participants (67% of those approached) out of a target of 60, participated:
• 13 in Group 1 received their usual care only - this is the ‘control’ group • 14 in Group 2 received standardised support and advice from an MS Nurse, in addition to their usual clinical care - this is the ‘MS Nurse Support’ group • 13 in Group 3 received MS Nurse Support plus Peer Support provided by people with experience of living with MS in addition to their usual clinical care – this is the ‘MS Nurse plus Peer Support’ group Across the three groups, participants were mostly women, were employed, between 31-40 years of age, and had relapsing-remitting MS.Twenty-six participants (from Group 2 and 3) received one support session with an MS Nurse (mostly face-to-face), and most of the sessions occurred more than 2 weeks after diagnosis. When asked about the timing of the sessions, the feedback from participants was mixed. Some people would have liked to have had the sessions much earlier following their diagnosis, whilst others felt they needed some time to process their diagnosis before meeting with an MS Nurse.
In total, there were 18 Peer Support sessions held, and five participants saw a Peer Support Worker more than once. Most of the initial Peer Support sessions occurred within a month after they had seen the MS Nurse, which participants felt was acceptable. Sessions mainly occurred face-to-face, with all the sessions during the pandemic occurring over the telephone. Participants reported that where it was possible to do so, they liked having the option to meet the Peer Support Workers in person or remotely (telephone or videoconferencing).
Feedback about the MS Nurse and Peer Support, based on interviews conducted with 20 people with MS, suggested that participants found it beneficial to receive individualised information from the MS Nurses, whom they considered trustworthy and credible sources of information. Participants also said that it was often easier to speak to someone non-clinical or non-medical, such as the Peer Support Workers, about how they were adjusting, based on a shared experience. Furthermore, participants reported that the information they were provided with about local MS support groups and online resources was particularly helpful.
Overall, participants thought the follow-up questionnaires were straightforward to complete and were relevant. However, questions asking how participants felt about how MS affected their confidence were more challenging to answer.
Altogether, our findings suggest that it is feasible to conduct a larger study, although some changes are required.
REC name
London - Bloomsbury Research Ethics Committee
REC reference
18/LO/1468
Date of REC Opinion
10 Sep 2018
REC opinion
Favourable Opinion