The PrEliMS Feasibility Trial
Providing Emotional Support Around the Point of Multiple Sclerosis Diagnosis (PrEliMS): A Feasibility Randomised Controlled Trial
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- MS Nurse Support
- Peer Support
What it measured
Main measures
Feasibility of trial procedures
Daily throughout data collection
FeasibilityAcceptability of trial procedures
Daily throughout data collection
FeasibilityFeasibility of randomisation protocol
Daily throughout data collection
FeasibilityFeasibility of recruitment
Daily throughout data collection
FeasibilityEstimating sample size needed for a Phase III RCT
Daily throughout data collection
Appropriateness of measures
Daily throughout data collection
Feasibility of self-report data collection
Daily throughout data collection
FeasibilityFeasibility of audio recording support sessions
Daily throughout data collection
FeasibilityAcceptability of interventions (Support 1 and Support 2)
Daily throughout intervention delivery
FeasibilityFeasibility of delivering Support 1 intervention
Daily throughout intervention delivery
FeasibilityFeasibility of delivering Support 2 intervention
Daily throughout intervention delivery
FeasibilityCredibility of interventions
Daily throughout data collection
Fidelity of intervention
Daily throughout intervention delivery
Documentation of usual care
Daily throughout data collection
Feasibility of collecting data for an economic evaluation using a bespoke service use questionnaire
Daily throughout data collection
Feasibility
Who could take part
MS (type not specified) · 18 and over
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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).
Papers
Loading reviews and guidelines…
History
Started
Nov 2018
Main results due
Oct 2020
Finished
Oct 2020