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The PrEliMS Feasibility Trial (PrEliMS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03735056
Recruitment Status : Recruiting
First Posted : November 8, 2018
Last Update Posted : December 3, 2018
Sponsor:
Collaborators:
Multiple Sclerosis Society UK
Swansea University
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Other: MS Nurse Support Other: Peer Support Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Providing Emotional Support Around the Point of Multiple Sclerosis Diagnosis (PrEliMS): A Feasibility Randomised Controlled Trial
Actual Study Start Date : November 30, 2018
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Group 1 (Usual care)
Receives usual care only.
Experimental: Group 2 (Usual care plus Support 1)
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.
Other: MS Nurse Support
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.

Experimental: Group 3 (Usual care plus Support 2)
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.
Other: MS Nurse Support
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.

Other: Peer Support
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 Outcome Measures :
  1. Feasibility of trial procedures [ Time Frame: Daily throughout data collection, 16 months ]

    [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, 16 months ]
    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, 16 months ]
    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, 16 months ]
    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, 16 months ]
    Sample size calculated through effect sizes from ANOVAs, standard deviations and attrition rates.

  6. Appropriateness of measures [ Time Frame: Daily throughout data collection, 16 months ]
    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, 16 months ]
    Number of missing online and postal data

  8. Feasibility of audio recording support sessions [ Time Frame: Daily throughout data collection, 16 months ]
    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, 10 months ]
    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, 10 months ]
    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, 10 months ]
    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, 16 months ]
    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, 10 months ]
    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, 16 months ]
    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, 16 months ]
    Number of missing or clearly invalid service use questionnaire data, completion rates, exploration of possible ceiling effects, feedback interview (qualitative) data.


Other Outcome Measures:
  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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03735056


Contacts
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Contact: Roshan das Nair, PhD +441158230589 roshan.dasnair@nottingham.ac.uk
Contact: Gogem Topcu, PhD gogem.topcu@nottingham.ac.uk

Locations
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United Kingdom
Nottingham University Hospitals NHS Trust Recruiting
Nottingham, United Kingdom
Contact: Nikos Evangelou, MD, DPhil    +441159709735    nikos.evangelou@nottingham.ac.uk   
Sponsors and Collaborators
University of Nottingham
Multiple Sclerosis Society UK
Swansea University
Investigators
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Principal Investigator: Roshan das Nair, PhD University of Nottingham
Study Director: Gogem Topcu, PhD University of Nottingham

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Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT03735056    
Other Study ID Numbers: 18053
First Posted: November 8, 2018    Key Record Dates
Last Update Posted: December 3, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Nottingham:
Diagnosis
Emotional support
Peer support
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases