Peer Support Impact on Therapeutic Adherence in Patients With Multiple Sclerosis (PAIR-SEP)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Multiple Sclerosis, Relapsing-remitting
• Intervention / Treatment: Other: Peer support

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Leïla MORET, MD - PhD; Phone Number: 332 02.40.84.69.24; Email: leila.moret@chu-nantes.fr
• Study Contact Backup: Name: Lebeaupin Maxime; Phone Number: +332 0253726305; Email: maxime.lebeaupin@chu-nantes.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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…)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; 30 MS (Multiple sclerosis, relapsing-remitting) patients	Other: Peer support; : 1 hour individual session with a peer support specialist at 1, 3 and 5 months after baseline; Other Names: non applicable
No Intervention: Control group; 30 MS (Multiple sclerosis, relapsing-remitting) patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	6 months

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Study Director: Leïla Moret, MD - PhD, CHU Nantes; Principal Investigator: Sandrine Wiertlewski, MD, CHU Nantes

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2022
• Primary Completion (Anticipated): March 1, 2024
• Study Completion (Anticipated): March 1, 2026

Study Registration Dates

• First Submitted: August 25, 2022
• First Submitted That Met QC Criteria: August 25, 2022
• First Posted (Actual): August 29, 2022

Study Record Updates

• Last Update Posted (Actual): September 1, 2022
• Last Update Submitted That Met QC Criteria: August 30, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: multiple sclerosis; peer support; therapeutic adherence
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Multiple Sclerosis, Relapsing-Remitting
• Other Study ID Numbers: RC22_0175

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: non applicable

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No