Territorial Implementation and Evaluation of a Multiple Sclerosis Expert Patient Program

NCT04988880 | Completed

• 1 other identifier: PR(AG)334/2021
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 6

Brief Summary

Introduction: Multiple sclerosis (MS) affects about 50,000 people in Spain, so it is essential to implement health interventions that meet their needs and demands. Expert patient programs facilitate health-related empowerment through peer learning. From a study of focus groups that identified the characteristics and contents of an expert patient program for MS and the ongoing pilot tests, the need for implementation in the different reference units of Catalonia is established. Hypothesis: The territorial implementation in Catalonia of a Catalonia® Expert Patient Program for people with MS (PPEC-EM) based on peer learning will improve the quality of life, knowledge and self-management related to the health process of the participants. Objective: To deploy and evaluate the territorial implementation of a PPEC-EM based on peer learning regarding the quality of life, knowledge and self-management related to the health process of the participants. Methodology: Pre-post intervention multicenter clinical study. This study will begin after the approval of the respective Ethics Committees. The deployment will consist of 12 groups of patients (2 per unit): 6 groups with people with recurrent MS and 6 groups with people with progressive MS. A patient with MS previously trained by a team of health professionals will lead 9 educational group sessions (1 weekly session for 9 weeks) with 12 people with the same disease in order to improve the impact and self-management according to the health process. The main variable is the improvement of the quality of life and the secondary ones are the emotional impact, activation of the person, knowledge on the MS, fatigue, habits and lifestyles, use of the sanitary services and program-related experience of participants. All variables will be measured before and after the intervention and after 6 and 12 months. A pre-post comparability analysis will be developed in relation to the variables studied.

Conditions

Multiple Sclerosis; Quality of Life; Patient Empowerment; Patient Activation; Fatigue; Peer Group

Keywords

Peer Group; Multiple sclerosis; Patient Empowerment; Quality of life; Patient Activation; Fatigue

Outcome Measures

Primary Outcomes (1)

• Number of groups constituted in each unit compared to the number of groups planned.

  Number of peer support groups provided by each centre. It is intended to develop two groups per unit (one group with progressive forms and one group with relapsing.remitting forms)

  18 months from recruitment

Secondary Outcomes (8)

• Change in Quality of life measured by the Multiple Sclerosis Quality of Life 54 items (MSQOL54) from beginning of the intervention to end of intervention (9 weeks) and compared to 6 and 12 months after the end of the intervention.

  18 months from recruitment

• Change in emotional impact measured by the Hospital Anxiety and Depression Scale (HADS) from beginning of the intervention to end of intervention (9 weeks) and compared to 6 and 12 months after the end of the intervention.

  18 months from recruitment

• Change in fatigue management measured by the Fatigue Severity Scale (FSS) from beginning of the intervention to end of intervention (9 weeks) and compared to 6 and 12 months after the end of the intervention.

  18 months from recruitment

• Change in patient activation and engagement measured by the 13-item Patient Activation Measure (PAM-13) from beginning of the intervention to end of intervention (9 weeks) and compared to 6 and 12 months after the end of the intervention.

  18 months from recruitment

• Change in patient knowledge measured by the PPEC specific questionnaire about the MS knowledge from beginning of the intervention to end of intervention (9 weeks) and compared to 6 and 12 months after the end of the intervention.

  18 months from recruitment

Study Arms (2)

Relapsing multiple sclerosis group

EXPERIMENTAL

Multiple sclerosis relapsing groups: each unit will provide a group of participant with relapsing multiple sclerosis

Other: Multiple Sclerosis Expert Patient Program of Catalonia

Progressive multiple sclerosis group

EXPERIMENTAL

Multiple sclerosis progressive groups: each unit will provide a group of participants with progressive multiple sclerosis

Other: Multiple Sclerosis Expert Patient Program of Catalonia

Interventions

Multiple Sclerosis Expert Patient Program of Catalonia OTHER

It is intended to constitute 12 groups of patients (6 with relapsing and 6 for progressive MS; one of each type per unit). The study will be conducted virtually due to the current pandemic situation. Throughout 9 sessions (1 per week for 9 sessions), participants in the group will share knowledge and lived experiences on all aspects related to MS and their self-management. In each session there is a theoretical part to focus on the topic, conducted by the EP. Immediately afterwards, the EP will encourage interaction, facilitating the expression of doubts, questions or experiences about the contents. Its resolution will be sought among the group, resulting in empowerment and control over the health situation. The knowledge acquired will be based on the information provided by the EP and on the knowledge resulting from the life experiences regarding MS of all the people involved. In all sessions, a healthcare professional will act as an observer, providing help and support to the EP.

Also known as: PPEC-EM

Progressive multiple sclerosis group; Relapsing multiple sclerosis group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Expert Patient: diagnosis of MS, possibility to attend the sessions and signing of the informed consent.

You may not qualify if:

• Expert Patient: not to speak or write Spanish or Catalan, healthcare or educational professional, having aphasia or an auditory disorder that prevents interaction with the group; -1.5 SD score of the population mean in one of the 3 subtests of The International Brief Cognitive Assessment for Multiple Sclerosis (BICAMS), score above 11/21 on The Hospital Anxiety and Depression Scale (HADS), and psychopathological comorbidity or diagnosed mental disorder that prevents proper interaction with the group.

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (6)

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Centre d'Esclerosi Múltiple de Catalunya (Cemcat), Vall d'Hebron Barcelona Hospital Campus

Barcelona, Barcelona, 08035, Spain

Location

Center for Neuroimmunology. Advanced Imaging in Neuroimmunological Diseases lab (ImaginEM). Hospital Clinic Barcelona

Barcelona, Barcelona, 08036, Spain

Location

Unitat de Neuroimmunologia i Esclerosi Múltiple

Girona, Girona, 17007, Spain

Location

Hospital Universitari Arnau de Vilanova Lleida; Institut de Recerca Biomèdica de Lleida (IRBLleida)

Lleida, Lleida, 25198, Spain

Location

Hospital Universitari de Tarragona Joan XXIII; Salut Sant Joan de Reus - Baix Camp; Fundació Esclerosi Múltiple - Mas Sabater

Tarragona, Tarragona, 43005, Spain

Location

Related Publications (1)

• Robles-Sanchez MA, Amil-Bujan P, Bosch-Farre C, Coll-Martinez C, Arevalo MJ, Anglada E, Menendez R, Montalban X, Sastre-Garriga J, Ramio-Torrenta L, Bertran-Noguer C. 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. Front Neurol. 2023 May 18;14:1172640. doi: 10.3389/fneur.2023.1172640. eCollection 2023.

  PMID: 37273703 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Patient Participation; Fatigue

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Miguel Angel Robles Sanchez, RN

  Multiple Sclerosis Centre of Catalonia (Cemcat), Vall d'Hebron Barcelona Hospital Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pre-post intervention multicenter clinical study to evaluate the territorial implementation of a specific Multiple Sclerosis Expert Patient Program of Catalonia (PPEC-EM) based on peer learning regarding quality of life, knowledge and self-management related to the health process of participants in 6 areas in Catalonia. It will start after the approval of the respective CEICs. The deployment will consist of 12 groups of patients (2 per unit): 6 groups with people with recurrent MS and 6 with people with progressive MS.

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: August 4, 2021
• Study Start: November 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: July 31, 2024
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.

Locations

ES (6)