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. 2023 May 18:14:1172640.
doi: 10.3389/fneur.2023.1172640. eCollection 2023.

An expert patient program to improve the empowerment and quality of life of people with multiple sclerosis: protocol for a multicenter pre-post intervention study

Miguel Angel Robles-Sanchez  1   2   3 , Paloma Amil-Bujan  4 , Cristina Bosch-Farré  1 , Clàudia Coll-Martínez  5   6 , Maria Jesús Arévalo  2 , Elisenda Anglada  2 , Rebeca Menéndez  2 , Xavier Montalban  2 , Jaume Sastre-Garriga  2 , Lluís Ramió-Torrentà  5   6   7 , Carme Bertran-Noguer  1
Affiliations

An expert patient program to improve the empowerment and quality of life of people with multiple sclerosis: protocol for a multicenter pre-post intervention study

Miguel Angel Robles-Sanchez et al. Front Neurol. .

Abstract

Introduction: Multiple sclerosis (MS) causes a progressive disability, which substantially impacts the quality of life (QoL). Health interventions that meet the needs and demands of people with MS are essential to minimize QoL impairment. Expert patient programs (EPPs) facilitate health-related empowerment through peer learning. Based on a previous focus group study, we designed an EPP for MS coordinated by nursing professionals for implementation in the different MS reference units of Catalonia (Southwestern Europe). This study aims to evaluate the effects on quality of life, disease-related knowledge, and self-management related to the health process of the participants of the Expert Patient Program Catalonia™ for people with multiple sclerosis (EPPC-MS).

Methods: Pre-post intervention multicenter clinical study involving 12 groups of 12 participants: six groups including relapsing and six groups including progressive MS patients, with 144 participants from 7 MS reference units from all over Catalonia, organized in six teams. The intervention will consist of nine telematic learning peer-led sessions (one weekly session). The expert patient (EP) leading the sessions will be an individual with MS with disease-related knowledge, who will be further trained by nurses to lead the sessions. Study variables will be measured before and immediately after the intervention and 6 and 12 months after the end of the sessions and will include: QoL, emotional impact, activation of the person, MS-related knowledge, fatigue, habits and lifestyles, health services use, and program-related experience. Baseline characteristics considered will be sociodemographic data, date of MS diagnosis and type, family history, and treatment characteristics. Variables related to disease follow-up will be new relapses and characteristics and changes in the ongoing treatment. The number of sessions attended will also be collected. Study variables will be analyzed using a pre-post comparison.

Discussion: Peer-led learning programs led by EP help empower people with chronic conditions and offer them tools to improve their autonomy and QoL. This study's intervention will be performed remotely, offering advantages both for people with chronic conditions and the healthcare system regarding the facilitation of family and work conciliation, saving time, simplifying attendance to meetings, lowering costs, and using fewer material resources.

Trial registration: NCT04988880 on September 22, 2021.

Keywords: clinical research protocol; health education; health literacy; multiple sclerosis; patient empowerment; peer group; quality of life.

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Conflict of interest statement

MR-S received speaking or consulting honoraria, participated in scientific activities organized by Merck, Teva, Biogen, Novartis, Sanofi-Genzyme, Celgene, EXCEMED, and Roche, and was awarded the ECTRIMS MS Nurse Training Fellowship Programme and the Strategic Plan for Research and Innovation in Health 2016–2020 (PERIS). CC-M has received support for attending congresses from sanofi, merk, teva and novartis and is funded by a fellowship from the Departament de Salut de la Generalitat de Catalunya [SLT017/20/000115, 2021]. MA received speaking or consulting honoraria, participated in scientific activities in the last 2 years organized by Bristol-Myers Squibb/Celgene. XM received speaking honoraria and travel expenses for participation in scientific meetings, has been a steering committee member of clinical trials or participated in advisory boards of clinical trials in the past years with Abbvie, Actelion, Alexion, Biogen, Bristol-Myers Squibb/Celgene, EMD Serono, Genzyme, Hoffmann-La Roche, Immunic, Janssen Pharmaceuticals, Medday, Merck, Mylan, Nervgen, Novartis, Sandoz, Sanofi-Genzyme, Teva Pharmaceutical, TG Therapeutics, Excemed, MSIF and NMSS. JS-G received speaking or consulting honoraria and attended scientific activities in the last 2 years organized by Merck, Teva, Bial, EXCEMED, Biogen, Celgene, Novartis, Sanofi-Genzyme, and Roche; and is the director of the “Revista de Neurologia” (Neurology Journal) and an editorial board member of the Multiple Sclerosis Journal. LR-T has received speaking or consulting honoraria, attended scientific activities organized by Merck, Teva, Biogen, Novartis, Sanofi, Roche, Bristol-Myers-Squibb, Almirall, and Mylan, and participated in advisory boards organized by Sanofi, Merck, Roche, Biogen, Novartis, Bristol-Myers-Squibb, and Almirall. PA-B, the coordinator of the Expert Patient Program Catalunya. CC-M has received support for attending congresses from Bristol Myers Squibb, Sanofi, Merck, and Novartis and is funded by a fellowship from the Departament de Salut de la Generalitat de Catalunya [SLT017/20/000115, 2021]. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
Location of the seven participating multiple sclerosis units. The line between the hospital in Tarragona and the hospital in Reus indicates that these 2 units will participate as a joint team, resulting in total of six participating teams.
Figure 2
Figure 2
Flow diagram and timeline of participants. BICAMS, Brief International Cognitive Assessment for Multiple Sclerosis; HADS, Hospital Anxiety and Depression Scale; M, month; MS, multiple sclerosis. *Participant candidates with BICAMS and HADS data obtained in the routine neurorehabilitation screening will not be required to sign an informed consent for the screening procedure, only to participate in the study.
Figure 3
Figure 3
Expert Patient Program timeline. EP, expert patient; EPPC-MS-Relapsing and EPPC-RMS, expert patient group including participants with relapsing multiple sclerosis; EPPC-MS-Progressive and EPPC-PMS, expert patient group including participants with progressive multiple sclerosis; G1 to G12, expert patient groups 1 to 12; M, month.
Figure 4
Figure 4
Assessments and data collection timeline. BICAMS, Brief International Cognitive Assessment for Multiple Sclerosis; EP, expert patient; FSS, Fatigue Severity Scale; HADS, Hospital Anxiety and Depression Scale; MSQoL-54; Multiple Sclerosis Quality of Life-54 items; PAM-13, patient activation measure; PRT, participants; RT, research team.
See this image and copyright information in PMC

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