Clinical trial NCT03735056: The PrEliMS Feasibility Trial
Official title: Providing Emotional Support Around the Point of Multiple Sclerosis Diagnosis (PrEliMS): A Feasibility Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Diagnosis
Emotional support
Peer support
Lead sponsor: University of Nottingham
Sponsor class: OTHER
Collaborators: name: Multiple Sclerosis Society UK
name: Swansea University
First posted: 2018-11-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of trial procedures
timeFrame: Daily throughout data collection
measure: Acceptability of trial procedures
timeFrame: Daily throughout data collection
measure: Feasibility of randomisation protocol
timeFrame: Daily throughout data collection
measure: Feasibility of recruitment
timeFrame: Daily throughout data collection
measure: Estimating sample size needed for a Phase III RCT
timeFrame: Daily throughout data collection
measure: Appropriateness of measures
timeFrame: Daily throughout data collection
measure: Feasibility of self-report data collection
timeFrame: Daily throughout data collection
measure: Feasibility of audio recording support sessions
timeFrame: Daily throughout data collection
measure: Acceptability of interventions (Support 1 and Support 2)
timeFrame: Daily throughout intervention delivery
measure: Feasibility of delivering Support 1 intervention
timeFrame: Daily throughout intervention delivery
measure: Feasibility of delivering Support 2 intervention
timeFrame: Daily throughout intervention delivery
measure: Credibility of interventions
timeFrame: Daily throughout data collection
measure: Fidelity of intervention
timeFrame: Daily throughout intervention delivery
measure: Documentation of usual care
timeFrame: Daily throughout data collection
measure: Feasibility of collecting data for an economic evaluation using a bespoke service use questionnaire
timeFrame: Daily throughout data collection
Secondary outcomes:
Other outcomes:
measure: Perceived stress
timeFrame: Baseline, 3-month follow-up, and 6-month follow-up
measure: Mood
timeFrame: Baseline, 3-month follow-up, and 6-month follow-up
measure: Psychological impact of MS
timeFrame: Baseline, 3-month follow-up, and 6-month follow-up
measure: Self-efficacy
timeFrame: Baseline, 3-month follow-up, and 6-month follow-up
measure: Health-related quality of life
timeFrame: Baseline, 3-month follow-up, and 6-month follow-up
measure: Service use questionnaire
timeFrame: Baseline, 3-month follow-up, and 6-month follow-up
Locations:
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
Study officials:
affiliation: University of Nottingham
name: Roshan das Nair, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Nottingham
name: Gogem Topcu, PhD
role: STUDY_DIRECTOR
References: