NCT05519553

Brief Summary

A mixed methods randomized controlled trial pilot study to assess peer support impact on relapsing-remitting multiple sclerosis patients' therapeutic adherence.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

Longer than P75 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 29, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

September 1, 2022

Status Verified

August 1, 2022

Enrollment Period

1.3 years

First QC Date

August 25, 2022

Last Update Submit

August 30, 2022

Conditions

Multiple Sclerosis, Relapsing-remitting

Keywords

multiple sclerosispeer supporttherapeutic adherence

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Secondary Outcomes (4)

  • Therapeutic compliance

    6 months

  • Participants' quality of life

    6 months

  • Emotional wellbeing

    6 months

  • Social support

    6 months

Study Arms (2)

Experimental group

EXPERIMENTAL

30 MS (Multiple sclerosis, relapsing-remitting) patients

Other: Peer support

Control group

NO INTERVENTION

30 MS (Multiple sclerosis, relapsing-remitting) patients

Interventions

Peer supportOTHER

: 1 hour individual session with a peer support specialist at 1, 3 and 5 months after baseline

Also known as: non applicable
Experimental group

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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…)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 38159942DERIVED

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-RemittingMultiple SclerosisTreatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesHealth BehaviorBehavior

Study Officials

  • Leïla Moret, MD - PhD

    Nantes University Hospital

    STUDY DIRECTOR

  • Sandrine Wiertlewski, MD

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Leïla MORET, MD - PhD

CONTACT

02.40.84.69.24leila.moret@chu-nantes.fr

Lebeaupin Maxime

CONTACT

0253726305maxime.lebeaupin@chu-nantes.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
non applicable
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: a mixed methods randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2022

First Posted

August 29, 2022

Study Start

November 1, 2022

Primary Completion

March 1, 2024

Study Completion

March 1, 2026

Last Updated

September 1, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

non applicable