The PrEliMS Feasibility Trial

Multiple Sclerosis Clinical Trial

— PrEliMS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03735056
• Other study ID #: 18053
• Status: Completed
• Phase: N/A
• Start date: November 30, 2018
• Est. completion date: October 31, 2020

Study information

• Verified date: March 2020
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 31, 2020
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
United Kingdom	Nottingham University Hospitals NHS Trust	Nottingham

Sponsors (3)

Lead Sponsor	Collaborator
University of Nottingham	Multiple Sclerosis Society UK, Swansea University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Perceived stress	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.	Baseline, 3-month follow-up, and 6-month follow-up
Other	Mood	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.	Baseline, 3-month follow-up, and 6-month follow-up
Other	Psychological impact of MS	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.	Baseline, 3-month follow-up, and 6-month follow-up
Other	Self-efficacy	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.	Baseline, 3-month follow-up, and 6-month follow-up
Other	Health-related quality of life	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.	Baseline, 3-month follow-up, and 6-month follow-up
Other	Service use questionnaire	Service use questionnaire was adapted from the service use questionnaire used in the CRAMMS trial (Lincoln et al. 2015).	Baseline, 3-month follow-up, and 6-month follow-up
Primary	Feasibility of trial procedures	[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).	Daily throughout data collection
Primary	Acceptability of trial procedures	Assessed through feedback interview (qualitative) data from participants and service providers on the trial procedures.	Daily throughout data collection
Primary	Feasibility of randomisation protocol	Assessed through feedback interview (qualitative) data on randomisation protocol and willingness and acceptance of patients to be randomised.	Daily throughout data collection
Primary	Feasibility of recruitment	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.	Daily throughout data collection
Primary	Estimating sample size needed for a Phase III RCT	Sample size calculated through effect sizes from ANOVAs, standard deviations and attrition rates.	Daily throughout data collection
Primary	Appropriateness of measures	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).	Daily throughout data collection
Primary	Feasibility of self-report data collection	Number of missing online and postal data	Daily throughout data collection
Primary	Feasibility of audio recording support sessions	Number of participants consenting to audio recording of sessions and feedback interview data	Daily throughout data collection
Primary	Acceptability of interventions (Support 1 and Support 2)	Drop-out rates (and reasons for withdrawal), number of Support 1 and Support 2 sessions completed, feedback interview data.	Daily throughout intervention delivery
Primary	Feasibility of delivering Support 1 intervention	Number of missed and rescheduled sessions, length of sessions (minutes), operational issues in delivering intervention through feedback interview data.	Daily throughout intervention delivery
Primary	Feasibility of delivering Support 2 intervention	Number of missed and rescheduled sessions, length of sessions (minutes), operational issues in delivering intervention through feedback interview data.	Daily throughout intervention delivery
Primary	Credibility of interventions	Assessed through qualitative feedback interview data (i.e., questions about the content of the intervention, changes experienced).	Daily throughout data collection
Primary	Fidelity of intervention	Fidelity rating on audio data from a sample of support sessions against criteria for PrEliMS model consistency.	Daily throughout intervention delivery
Primary	Documentation of usual care	Data obtained through service use questionnaire and feedback interviews.	Daily throughout data collection
Primary	Feasibility of collecting data for an economic evaluation using a bespoke service use questionnaire	Number of missing or clearly invalid service use questionnaire data, completion rates, exploration of possible ceiling effects, feedback interview (qualitative) data.	Daily throughout data collection