Multiple SclerosisPrEliMSNCT03735056
The PrEliMS Feasibility Trial
A study testing MS Nurse Support and Peer Support in people with Multiple Sclerosis, run by University of Nottingham at 1 site in United Kingdom.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- MS Nurse Support and Peer Support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Nov 2018to 31 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Nottingham University Hospitals NHS Trust
Nottingham
About this study
Official title: Providing Emotional Support Around the Point of Multiple Sclerosis Diagnosis (PrEliMS): A Feasibility Randomised Controlled 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).
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- MS Nurse Support, Peer Support
- Keywords
- Diagnosis, Emotional support, Peer support
- Medical subject headings
- Multiple Sclerosis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MS Nurse SupportOther
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 SupportOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Usual care) | No intervention | Receives usual care only. |
| Group 2 (Usual care plus Support 1) | Experimental | 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. Receives: Other: MS Nurse Support |
| Group 3 (Usual care plus Support 2) | Experimental | 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. Receives: Other: MS Nurse Support; Other: Peer Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Daily throughout data collection
Acceptability of trial procedures
Assessed through feedback interview (qualitative) data from participants and service providers on the trial procedures.
Measured: Daily throughout data collection
Feasibility of randomisation protocol
Assessed through feedback interview (qualitative) data on randomisation protocol and willingness and acceptance of patients to be randomised.
Measured: Daily throughout data collection
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.
Measured: Daily throughout data collection
Estimating sample size needed for a Phase III RCT
Sample size calculated through effect sizes from ANOVAs, standard deviations and attrition rates.
Measured: Daily throughout data collection
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).
Measured: Daily throughout data collection
Feasibility of self-report data collection
Number of missing online and postal data
Measured: Daily throughout data collection
Feasibility of audio recording support sessions
Number of participants consenting to audio recording of sessions and feedback interview data
Measured: Daily throughout data collection
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.
Measured: Daily throughout intervention delivery
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.
Measured: Daily throughout intervention delivery
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.
Measured: Daily throughout intervention delivery
Credibility of interventions
Assessed through qualitative feedback interview data (i.e., questions about the content of the intervention, changes experienced).
Measured: Daily throughout data collection
Fidelity of intervention
Fidelity rating on audio data from a sample of support sessions against criteria for PrEliMS model consistency.
Measured: Daily throughout intervention delivery
Documentation of usual care
Data obtained through service use questionnaire and feedback interviews.
Measured: Daily throughout data collection
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.
Measured: Daily throughout data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start30 Nov 2018
- Primary completion31 Oct 2020
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Multiple Sclerosis Society UK, Swansea University
- Responsible party
- Sponsor
- Investigators
- Roshan das Nair, PhD, Principal investigator, University of NottinghamGogem Topcu, PhD, Study director, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03735056
- Sponsor's protocol ID
- 18053
- Acronym
- PrEliMS
- Status last verified
- Mar 2020
- First submitted
- 21 Sep 2018
- Last updated
- 9 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Providing Emotional Support Around the Point of Multiple Sclerosis Diagnosis (PrEliMS): A Feasibility Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03735056
- Acronym / sponsor ID
- PrEliMS / 18053
- Conditions
- Multiple Sclerosis
- Keywords
- Diagnosis, Emotional support, Peer support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Multiple Sclerosis Society UK, Swansea University
- Study start
- 30 Nov 2018 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 8 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Usual care) | No intervention | –Receives usual care only. |
| Group 2 (Usual care plus Support 1) | Experimental | Other: MS Nurse SupportReceives 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. |
| Group 3 (Usual care plus Support 2) | Experimental | Other: MS Nurse Support, Other: Peer SupportReceives 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MS Nurse SupportMS 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 | Group 2 (Usual care plus Support 1), Group 3 (Usual care plus Support 2) |
| Peer SupportPeer 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. | Other | Group 3 (Usual care plus Support 2) |
Primary outcome
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).
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.
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.
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.
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.
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).
Feasibility of self-report data collection
Time frame: Daily throughout data collection
Number of missing online and postal data
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
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.
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.
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.
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).
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.
Documentation of usual care
Time frame: Daily throughout data collection
Data obtained through service use questionnaire and feedback interviews.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roshan das Nair, PhD principal investigator
University of Nottingham
Gogem Topcu, PhD study director
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MS Nurse Support and Peer Support in people with Multiple Sclerosis, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of trial procedures (time frame: Daily throughout data collection). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2020; AzTrials last refreshed its copy on 27 Oct 2026.