Multiple Sclerosis, Relapsing-remittingPAIR-SEPNCT05519553
Peer Support Impact on Therapeutic Adherence in Patients With Multiple Sclerosis
A study testing Peer support in people with Multiple Sclerosis, Relapsing-remitting, run by Nantes University Hospital at 1 site in France.
Trial summary
A mixed methods randomized controlled trial pilot study to assess peer support impact on relapsing-remitting multiple sclerosis patients' therapeutic adherence. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Multiple Sclerosis, Relapsing-remitting
- What is being tested?
- Peer support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 17 May 2023to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients
- With relapsing-remitting MS according to 2017 revised Mc Donald criteria
- Attending medical consultation at Nantes University Hospital Neurology Department
- For whom background drug therapy is needed (oral or injectable)
- Who gave consent to participate in trial
Who cannot join
- Primary-progressive or secondary-progressive MS patients
- Patients under protection of vulnerable adults measure or convicted
- Patients not fluent in French
- Patients with severe cognitive impairment, who may find difficult filling out questionnaires properly
- Patients with a risk of follow-up interruption (move, nomadism…)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Peer Support Impact on Therapeutic Adherence in Patients With Multiple Sclerosis: a Mixed Methods Randomized Controlled Trial Pilot Study
A mixed methods randomized controlled trial pilot study to assess peer support impact on relapsing-remitting multiple sclerosis patients' therapeutic adherence.
Read the detailed description
Multiple sclerosis (MS) is a debilitating and incurable chronic disease. Patients might benefit from peer support provided by patients entitled to give advice on daily life management with MS. Studies have shown that peer support can enhance chronic patients' quality of life in Psychiatry and Oncology.
This pilot study aims at assessing the impact of peer support on therapeutic adherence and quality of life in patients with MS, but also to appraise the project feasibility and acceptability among the healthcare team, with large-scale implementation in mind.
This mixed methods pilot study consists in a monocentric open-label randomized controlled trial. It is located in Nantes, France, and aims to recruit 60 patients with relapsing-remitting MS undergoing drug therapy from the Nantes University Hospital Neurology Department. Patients will be randomized 1:1 to receive either usual care only or usual care combined with peer support (3 individual sessions at 1, 3 and 5 months with a peer support specialist).
Primary outcome is enhanced therapeutic adherence 6 months after baseline, secondary outcomes include therapeutic compliance, quality of life, anxiety and depression, social support. All dimensions will be assessed using validated health questionnaires at baseline and at 6 months.
Interventions acceptability and feasibility will be evaluated using qualitative methods: undirected interviews with patients from the intervention group and 2 focus-groups, one with the peer support specialists and the other with the healthcare team.
- Conditions
- Multiple Sclerosis, Relapsing-remitting
- Being tested
- Peer support
- Keywords
- multiple sclerosis, peer support, therapeutic adherence
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer supportOther
Also called non applicable
: 1 hour individual session with a peer support specialist at 1, 3 and 5 months after baseline
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 30 MS (Multiple sclerosis, relapsing-remitting) patients Receives: Other: Peer support |
| Control group | No intervention | 30 MS (Multiple sclerosis, relapsing-remitting) patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic adherence
Description : score difference at baseline and 6 months of the " Necessity " and " Concerns " subscales of BMQ-Specific (Beliefs about medicines questionnaire) compared between control and intervention groups.
A score, between 5 and 25, is calculated for each subscale by making a sum of the answers. Next, score difference between Necessity and Concerns (NCF) is calculated. NCF varies between -20 and +20. Value above 0 means that perceived treatment necessity exceeds treatment associated concerns. The more NCF comes close to +20, the better is the treatment risk/benefit balance.
Measured: 6 months
Secondary outcomes (4)
Therapeutic compliance
score difference at baseline and 6 months of MARS (Medication Adherence Rating Scale) questionnaire compared between control and intervention groups.
A final score, between 5 and 25, is calculated by making a sum of the answers. If final score is 21 or above, or if every item is scored at least 4 points, the patient is deemed compliant.
Measured: 6 months
Participants' quality of life
score difference at baseline and 6 months of MusiQoL-MCAT (Multidimensional Computerized Adaptive Short-Form Quality of Life Questionnaire Developed and Validated for Multiple Sclerosis) compared between control and intervention groups.
The score on each dimension is obtained by computing the mean of the item scores for that dimension. All dimension scores are linearly transformed to a 0 to 100 scale. A global index score is computed as the mean of the dimension scores. Higher scores indicate a higher level of quality of life.
Measured: 6 months
Emotional wellbeing
score difference at baseline and 6 months of HAD (Hospital Anxiety and Depression) questionnaire compared between control and intervention groups.
A final score, between 0 and 21, is calculated by making a sum of the answers for each subscale. A subscale score >8 denotes anxiety or depression. The higher the score is, the worse the severity of depression or anxiety symptoms.
Measured: 6 months
Social support
score difference at baseline and 6 months of SSQ6 (Social Support Questionnaire) compared between control and intervention groups.
Two scores are calculated by making a sum of the answers in each dimension: N score (availability) ranges from 0 to 54 and S score (satisfaction) ranges from 6 to 36. Higher scores indicate a higher level of support availability or satisfaction.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start17 May 2023
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple Sclerosis, Relapsing-remittingStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a mixed methods randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leïla Moret, MD - PhD, Study director, Nantes University HospitalSandrine Wiertlewski, MD, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05519553
- Sponsor's protocol ID
- RC22_0175
- Acronym
- PAIR-SEP
- Status last verified
- Jun 2026
- First submitted
- 25 Aug 2022
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: non applicable
Publications
Guilmault L, Wiertlewski S, Malloggi L, Rousseau C, Jacq-Foucher M, Leclere B, Moret L. Peer support impact on therapeutic adherence in patients with multiple sclerosis: a mixed-methods pilot trial protocol. BMJ Open. 2023 Dec 30;13(12):e071336. doi: 10.1136/bmjopen-2022-071336.
PubMed 38159942
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer Support Impact on Therapeutic Adherence in Patients With Multiple Sclerosis: a Mixed Methods Randomized Controlled Trial Pilot Study
- ClinicalTrials.gov ID
- NCT05519553
- Acronym / sponsor ID
- PAIR-SEP / RC22_0175
- Conditions
- Multiple Sclerosis, Relapsing-remitting
- Keywords
- multiple sclerosis, peer support, therapeutic adherence
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 17 May 2023 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 29 Aug 2022 (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.
A mixed methods randomized controlled trial pilot study to assess peer support impact on relapsing-remitting multiple sclerosis patients' therapeutic adherence.
Detailed description
Multiple sclerosis (MS) is a debilitating and incurable chronic disease. Patients might benefit from peer support provided by patients entitled to give advice on daily life management with MS. Studies have shown that peer support can enhance chronic patients' quality of life in Psychiatry and Oncology.
This pilot study aims at assessing the impact of peer support on therapeutic adherence and quality of life in patients with MS, but also to appraise the project feasibility and acceptability among the healthcare team, with large-scale implementation in mind.
This mixed methods pilot study consists in a monocentric open-label randomized controlled trial. It is located in Nantes, France, and aims to recruit 60 patients with relapsing-remitting MS undergoing drug therapy from the Nantes University Hospital Neurology Department. Patients will be randomized 1:1 to receive either usual care only or usual care combined with peer support (3 individual sessions at 1, 3 and 5 months with a peer support specialist).
Primary outcome is enhanced therapeutic adherence 6 months after baseline, secondary outcomes include therapeutic compliance, quality of life, anxiety and depression, social support. All dimensions will be assessed using validated health questionnaires at baseline and at 6 months.
Interventions acceptability and feasibility will be evaluated using qualitative methods: undirected interviews with patients from the intervention group and 2 focus-groups, one with the peer support specialists and the other with the healthcare team.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- a mixed methods randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Peer support30 MS (Multiple sclerosis, relapsing-remitting) patients |
| Control group | No intervention | –30 MS (Multiple sclerosis, relapsing-remitting) patients |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients
- With relapsing-remitting MS according to 2017 revised Mc Donald criteria
- Attending medical consultation at Nantes University Hospital Neurology Department
- For whom background drug therapy is needed (oral or injectable)
- Who gave consent to participate in trial
Key exclusion criteria (5 listed)
- Primary-progressive or secondary-progressive MS patients
- Patients under protection of vulnerable adults measure or convicted
- Patients not fluent in French
- Patients with severe cognitive impairment, who may find difficult filling out questionnaires properly
- Patients with a risk of follow-up interruption (move, nomadism…)
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 |
|---|---|---|
| Peer supportAlso: non applicable: 1 hour individual session with a peer support specialist at 1, 3 and 5 months after baseline | Other | Experimental group |
Primary outcome
Therapeutic adherence
Time frame: 6 months
Description : score difference at baseline and 6 months of the " Necessity " and " Concerns " subscales of BMQ-Specific (Beliefs about medicines questionnaire) compared between control and intervention groups. A score, between 5 and 25, is calculated for each subscale by making a sum of the answers. Next, score difference between Necessity and Concerns (NCF) is calculated. NCF varies between -20 and +20. Value above 0 means that perceived treatment necessity exceeds treatment associated concerns. The more NCF comes close to +20, the better is the treatment risk/benefit balance.
4 secondary outcomes
Therapeutic compliance
Time frame: 6 months
Participants' quality of life
Time frame: 6 months
Emotional wellbeing
Time frame: 6 months
Social support
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Derived from this study: PubMed 38159942Guilmault L, Wiertlewski S, Malloggi L, Rousseau C, Jacq-Foucher M, Leclere B, Moret L. Peer support impact on therapeutic adherence in patients with multiple sclerosis: a mixed-methods pilot trial protocol. BMJ Open. 2023 Dec 30;13(12):e071336. doi: 10.1136/bmjopen-2022-071336.
- Individual participant dataSharing planned: No. non applicable
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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.
Leïla Moret, MD - PhD study director
Nantes University Hospital
Sandrine Wiertlewski, MD principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer support in people with Multiple Sclerosis, Relapsing-remitting, run by Nantes University Hospital at 1 site in France.
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 5 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: under way, not looking for participants, as of the sponsor's last update on 24 Jun 2026. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
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?
Therapeutic adherence (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05519553, which also lists 1 linked publication.
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 24 Jun 2026.