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NCT Number: NCT03735056

The PrEliMS Feasibility Trial

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).

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Disease Immune System Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MS Nurse Support

Other

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

Other

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.

Primary outcomes

  1. Feasibility of trial procedures

    Time frame: 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).

  2. Acceptability of trial procedures

    Time frame: Daily throughout data collection

    Assessed through feedback interview (qualitative) data from participants and service providers on the trial procedures.

  3. Feasibility of randomisation protocol

    Time frame: Daily throughout data collection

    Assessed through feedback interview (qualitative) data on randomisation protocol and willingness and acceptance of patients to be randomised.

  4. Feasibility of recruitment

    Time frame: 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.

  5. Estimating sample size needed for a Phase III RCT

    Time frame: Daily throughout data collection

    Sample size calculated through effect sizes from ANOVAs, standard deviations and attrition rates.

  6. Appropriateness of measures

    Time frame: 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).

  7. Feasibility of self-report data collection

    Time frame: Daily throughout data collection

    Number of missing online and postal data

  8. Feasibility of audio recording support sessions

    Time frame: Daily throughout data collection

    Number of participants consenting to audio recording of sessions and feedback interview data

  9. Acceptability of interventions (Support 1 and Support 2)

    Time frame: Daily throughout intervention delivery

    Drop-out rates (and reasons for withdrawal), number of Support 1 and Support 2 sessions completed, feedback interview data.

  10. Feasibility of delivering Support 1 intervention

    Time frame: Daily throughout intervention delivery

    Number of missed and rescheduled sessions, length of sessions (minutes), operational issues in delivering intervention through feedback interview data.

  11. Feasibility of delivering Support 2 intervention

    Time frame: Daily throughout intervention delivery

    Number of missed and rescheduled sessions, length of sessions (minutes), operational issues in delivering intervention through feedback interview data.

  12. Credibility of interventions

    Time frame: Daily throughout data collection

    Assessed through qualitative feedback interview data (i.e., questions about the content of the intervention, changes experienced).

  13. Fidelity of intervention

    Time frame: Daily throughout intervention delivery

    Fidelity rating on audio data from a sample of support sessions against criteria for PrEliMS model consistency.

  14. Documentation of usual care

    Time frame: Daily throughout data collection

    Data obtained through service use questionnaire and feedback interviews.

  15. Feasibility of collecting data for an economic evaluation using a bespoke service use questionnaire

    Time frame: 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.

Other outcomes

  1. Perceived stress

    Time frame: Baseline, 3-month follow-up, and 6-month follow-up

    Perceived Stress Scale 4 (PSS4; Cohen, Kamarck, & Mersmelstein, 1983; Cohen & Williamson, 1988) to measure the level of perceived stress among people with MS by assessing their level of perceived uncontrollability and unpredictability on a 5 point scale (0=never, 1=almost never, 2=sometimes, 3=fairly often, 4=very often). The scores for each question are added (after reverse scoring two of the four questions) to give a total score ranging from 0 to 16, with higher scores indicating higher stress.

  2. Mood

    Time frame: Baseline, 3-month follow-up, and 6-month follow-up

    Hospital Anxiety and Depression Scale (HADS; Zigmond & Snaith, 1983) will be used to measure the level of mood disturbances. It is a 14-item scale and each item is scored from 0 to 3. The total scores range from 0 to 21 for the anxiety subscale and also for the depression subscale, with higher scores indicating greater levels of anxiety or depression.

  3. Psychological impact of MS

    Time frame: Baseline, 3-month follow-up, and 6-month follow-up

    Multiple Sclerosis Impact Scale 29 (MSIS-29) - psychological subscale (Rasch, version 2; Hobart, Lamping, Fitzpatrick, Riazi, & Thompson, 2001; Ramp, Khan, Misajon, & Pallant, 2009) will be used to assess the perceived psychological impact of MS. Psychological subscale has 9 items with 4-point response categories for each item ("not at all", "a little", "moderately", "extremely"). The total score range from 9 to 36, with lower scores indicating little impact of MS and higher scores indicating greater impact.

  4. Self-efficacy

    Time frame: Baseline, 3-month follow-up, and 6-month follow-up

    Multiple Sclerosis Self-efficacy Scale (MSSE; Rigby, Domenech, Thornton, Tedman, & Young, 2003) will be used to assess the extent to which participants feel in control of their condition. The scale has 14 items. Each item is presented with a 6-point Likert scale, ranging from "Strongly Disagree" to "Strongly Agree". The scores for each item are added (after reverse scoring six of the 14 items) to give a total score ranging from 14-84, with higher scores indicating an elevated level of self-efficacy.

  5. Health-related quality of life

    Time frame: Baseline, 3-month follow-up, and 6-month follow-up

    EQ-5D-5L (Herdman et al., 2011) will be used as a generic patient-reported measure of health-related quality of life and to derive health utilities.

  6. Service use questionnaire

    Time frame: Baseline, 3-month follow-up, and 6-month follow-up

    Service use questionnaire was adapted from the service use questionnaire used in the CRAMMS trial (Lincoln et al. 2015).

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Collaborators

  • Multiple Sclerosis Society UK
  • Swansea University

Registry information

Official study title

Providing Emotional Support Around the Point of Multiple Sclerosis Diagnosis (PrEliMS): A Feasibility Randomised Controlled Trial

Acronym: PrEliMS

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 8, 2018
Registry last updated
Nov 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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