The PrEliMS study is a mixed-methods feasibility randomised controlled trial of a point of diagnosis intervention programme which aims to provide emotional support for newly diagnosed people with Multiple Sclerosis (MS). This feasibility study will enable us to plan for a definitive trial to evaluate the clinical and cost-effectiveness of this point of diagnosis intervention programme. The aim is to assess the feasibility of the trial procedures and intervention, and to evaluate the key feasibility parameters before proceeding to a definitive trial. Participants (N=60) will be randomised into three groups: (1) usual care; (2) usual care + Support 1 (MS Nurse Support); (2) usual care + Support 2 (MS Nurse Support plus Peer Support).
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 randomised into to one of three groups: (1) usual care; (2) usual care + Support 1 (MS Nurse Support); (2) usual care + Support 2 (MS Nurse Support plus Peer Support). Group 1 (20 patients) will not receive any intervention. Group 2 (20 patients) will receive Support 1 which will include one face-to-face support session delivered by an MS Nurse. Group 3 (20 patients) will receive Support 2 which includes MS Nurse Support (i.e., Support 1) plus Peer Support. Peer Support will include a minimum of two peer support session delivered by Peer Support Workers (i.e. patients with lived experiences). All groups will receive usual care. The outcome measures will be collected at 3 and 6 months after randomisation by all participants. Feedback interviews with up to 21 participants (7 from each group) and up to 10 service providers (5 MS Nurses who delivered the MS Nurse Support and 5 Peer Support Workers who delivered the Peer Support) 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
40
MS Nurse Support intervention is multi-faceted, involving various components (i.e. information provision and emotional support), and a range of strategies and techniques (e.g. psychoeducation, acceptance and commitment), delivered by MS Nurse Specialists, to provide standardised support and advice to patients at diagnosis, to establish and sustain coping strategies. MS Nurse Support intervention is person-centred and tailored to the needs and lifestyle of each participant.
Peer Support will be delivered by Peer Support Workers using information provision and supportive listening to provide support and advice to patients at diagnosis, and to provide patients the opportunity to talk freely, extensively and confidentially about their experiences, thoughts and feelings about MS diagnosis and its effects on their lives in a non-judgmental and safe environment. Peer Support intervention is person-centred and tailored to the needs and lifestyle of each participant.
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom
Feasibility of trial procedures
\[Note: As feasibility studies are used to estimate important parameters to inform the design of a full trial (NIHR, 2018), we outline the key outcomes related to feasibility. These are described below. Please see Outcome 1-15.\] Feasibility of trial procedures will be assessed through feedback interview (qualitative) data from participants and service providers (i.e., questions about the research process/procedures, and suggested changes to the study).
Time frame: Daily throughout data collection
Acceptability of trial procedures
Assessed through feedback interview (qualitative) data from participants and service providers on the trial procedures.
Time frame: Daily throughout data collection
Feasibility of randomisation protocol
Assessed through feedback interview (qualitative) data on randomisation protocol and willingness and acceptance of patients to be randomised.
Time frame: Daily throughout data collection
Feasibility of recruitment
Number of those eligible who expressed interest/discussed with researcher, number of consenting/randomised patients, reasons for non-participation, retention rates, feedback interview (qualitative) data.
Time frame: Daily throughout data collection
Estimating sample size needed for a Phase III RCT
Sample size calculated through effect sizes from ANOVAs, standard deviations and attrition rates.
Time frame: Daily throughout data collection
Appropriateness of measures
Completion rates of outcome measures, number of missing online and postal data, estimates of time (minutes) taken to complete measures (from online/phone data or feedback interview data).
Time frame: Daily throughout data collection
Feasibility of self-report data collection
Number of missing online and postal data
Time frame: Daily throughout data collection
Feasibility of audio recording support sessions
Number of participants consenting to audio recording of sessions and feedback interview data
Time frame: Daily throughout data collection
Acceptability of interventions (Support 1 and Support 2)
Drop-out rates (and reasons for withdrawal), number of Support 1 and Support 2 sessions completed, feedback interview data.
Time frame: Daily throughout intervention delivery
Feasibility of delivering Support 1 intervention
Number of missed and rescheduled sessions, length of sessions (minutes), operational issues in delivering intervention through feedback interview data.
Time frame: Daily throughout intervention delivery
Feasibility of delivering Support 2 intervention
Number of missed and rescheduled sessions, length of sessions (minutes), operational issues in delivering intervention through feedback interview data.
Time frame: Daily throughout intervention delivery
Credibility of interventions
Assessed through qualitative feedback interview data (i.e., questions about the content of the intervention, changes experienced).
Time frame: Daily throughout data collection
Fidelity of intervention
Fidelity rating on audio data from a sample of support sessions against criteria for PrEliMS model consistency.
Time frame: Daily throughout intervention delivery
Documentation of usual care
Data obtained through service use questionnaire and feedback interviews.
Time frame: Daily throughout data collection
Feasibility of collecting data for an economic evaluation using a bespoke service use questionnaire
Number of missing or clearly invalid service use questionnaire data, completion rates, exploration of possible ceiling effects, feedback interview (qualitative) data.
Time frame: Daily throughout data collection
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