The PrEliMS Feasibility Trial

Not Applicable

Completed

• Conditions: Multiple Sclerosis
• Interventions: Other: MS Nurse Support; Other: Peer Support

• Registration Number: NCT03735056
• Lead Sponsor: University of Nottingham

Brief Summary

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).

Detailed Description

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 Timeline

• Study First Submitted: 2018-09-21
• Study First Submitted QC: 2018-11-07
• Study First Posted: 2018-11-08
• Study Start: 2018-11-30
• Status Verified: 2020-03
• Primary Completion: 2020-10-31
• Study Completion: 2020-10-31
• Last Update Submitted: 2020-11-05
• Last Update Posted: 2020-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Patients will be eligible to join the trial if they:

• are 18 years or over
• have recently received a diagnosis of MS (any type of MS) or currently going through MS diagnosis process)
• can communicate in English
• able and willing to give consent
• not receiving psychological intervention

Exclusion Criteria

Patients will be excluded if they:

• have a severe co-morbid psychiatric condition (e.g. dementia), as reported by patients or their carers or confirmed by the clinical team making the initial approach
• are currently receiving psychological interventions or received this within the last three months (we will not exclude those on medication for their mood problems but will record this information).
• do not have mental capacity to consent to take part in the trial
• are unable to communicate in English

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 3 (Usual care plus Support 2)	MS Nurse Support	Receives usual care plus Support 2 (i.e. MS Nurse Support plus Peer Support). In addition to receiving the MS Nurse Support (i.e. Support 1, as described in Group 2), this group will also receive peer support which will be provided by Peer Support Workers who are patients/carers with lived experience and who are recruited and trained to deliver peer support under supervision from experienced clinical psychologists. It will be delivered one-to-one, face-to-face (in a community setting or via Skype, based on participants' preferences). Patients in this group will be triaged to a Peer Support Worker by the MS Nurse during the 2-week MS Nurse Support session. The sessions will be scheduled to a convenient time between weeks 2-6 after diagnosis and each session will last up to 60 minutes.
Group 2 (Usual care plus Support 1)	MS Nurse Support	Receives usual care plus Support 1 (MS Nurse Support) which includes one one-to-one, face-to-face session with an MS Nurse Specialist in a hospital setting (or via Skype). The session will include answering newly diagnosed patients' questions about MS, providing psychoeducation and teaching Acceptance and Commitment strategies (Hayes, Strosahl \& Wilson, 1999), and referring to other services (based on needs). Participants will also be given a self-help workbook ('Better living with a diagnosis of MS: Patient Workbook') by the nurses. This session will take place within 2 weeks of diagnosis and last up to 90 minutes. It will be supplemented by phone calls (depending on participant needs). MS Nurses will receive training and on-going supervision from experienced clinical psychologists.
Group 3 (Usual care plus Support 2)	Peer Support	Receives usual care plus Support 2 (i.e. MS Nurse Support plus Peer Support). In addition to receiving the MS Nurse Support (i.e. Support 1, as described in Group 2), this group will also receive peer support which will be provided by Peer Support Workers who are patients/carers with lived experience and who are recruited and trained to deliver peer support under supervision from experienced clinical psychologists. It will be delivered one-to-one, face-to-face (in a community setting or via Skype, based on participants' preferences). Patients in this group will be triaged to a Peer Support Worker by the MS Nurse during the 2-week MS Nurse Support session. The sessions will be scheduled to a convenient time between weeks 2-6 after diagnosis and each session will last up to 60 minutes.

Primary Outcome Measures

Name	Time	Method
Documentation of usual care	Daily throughout data collection	Data obtained through service use questionnaire and feedback interviews.
Feasibility of collecting data for an economic evaluation using a bespoke service use questionnaire	Daily throughout data collection	Number of missing or clearly invalid service use questionnaire data, completion rates, exploration of possible ceiling effects, feedback interview (qualitative) data.
Credibility of interventions	Daily throughout data collection	Assessed through qualitative feedback interview data (i.e., questions about the content of the intervention, changes experienced).
Feasibility of delivering Support 2 intervention	Daily throughout intervention delivery	Number of missed and rescheduled sessions, length of sessions (minutes), operational issues in delivering intervention through feedback interview data.
Acceptability of trial procedures	Daily throughout data collection	Assessed through feedback interview (qualitative) data from participants and service providers on the trial procedures.
Feasibility of recruitment	Daily throughout data collection	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.
Feasibility of randomisation protocol	Daily throughout data collection	Assessed through feedback interview (qualitative) data on randomisation protocol and willingness and acceptance of patients to be randomised.
Estimating sample size needed for a Phase III RCT	Daily throughout data collection	Sample size calculated through effect sizes from ANOVAs, standard deviations and attrition rates.
Feasibility of self-report data collection	Daily throughout data collection	Number of missing online and postal data
Feasibility of delivering Support 1 intervention	Daily throughout intervention delivery	Number of missed and rescheduled sessions, length of sessions (minutes), operational issues in delivering intervention through feedback interview data.
Feasibility of trial procedures	Daily throughout data collection	\[Note: As feasibility studies are used to estimate important parameters to inform the design of a full trial (NIHR, 2018), we outline the key outcomes related to feasibility. These are described below. Please see Outcome 1-15.\]; 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).
Appropriateness of measures	Daily throughout data collection	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).
Feasibility of audio recording support sessions	Daily throughout data collection	Number of participants consenting to audio recording of sessions and feedback interview data
Acceptability of interventions (Support 1 and Support 2)	Daily throughout intervention delivery	Drop-out rates (and reasons for withdrawal), number of Support 1 and Support 2 sessions completed, feedback interview data.
Fidelity of intervention	Daily throughout intervention delivery	Fidelity rating on audio data from a sample of support sessions against criteria for PrEliMS model consistency.

Trial Locations

Locations (1)

Nottingham University Hospitals NHS Trust; 🇬🇧 Nottingham, United Kingdom