Clinical trial NCT05519553: Peer Support Impact on Therapeutic Adherence in Patients With Multiple Sclerosis
Official title: Peer Support Impact on Therapeutic Adherence in Patients With Multiple Sclerosis: a Mixed Methods Randomized Controlled Trial Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Multiple Sclerosis, Relapsing-remitting
Keywords: multiple sclerosis
peer support
therapeutic adherence
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2022-08-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a mixed methods randomized controlled trial
Primary purpose: OTHER

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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...)

Primary outcomes:
measure: Therapeutic adherence
timeFrame: 6 months
Secondary outcomes:
measure: Therapeutic compliance
timeFrame: 6 months
measure: Participants' quality of life
timeFrame: 6 months
measure: Emotional wellbeing
timeFrame: 6 months
measure: Social support
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Nantes University Hospital
name: Leïla Moret, MD - PhD
role: STUDY_DIRECTOR
affiliation: Nantes University Hospital
name: Sandrine Wiertlewski, MD
role: PRINCIPAL_INVESTIGATOR
References: