The PrEliMS Feasibility Trial

University of Nottingham

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Other: MS Nurse Support; Other: Peer Support

Study type: Interventional

Funder types: Other

Identifiers

NCT03735056

18053

Details and patient eligibility

About

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).

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 3 patient groups

Group 1 (Usual care)

No Intervention group

Description:

Receives usual care only.

Group 2 (Usual care plus Support 1)

Experimental group

Description:

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.

Treatment:

Other: MS Nurse Support

Group 3 (Usual care plus Support 2)

Experimental group

Description:

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.

Treatment:

Other: MS Nurse Support

Other: Peer Support