NCT04988880Completed
Territorial Implementation and Evaluation of a Multiple Sclerosis Expert Patient Program
Territorial Implementation and Evaluation of an Expert Patient Program to Improve the Empowerment and Quality of Life of People With Multiple Sclerosis
Source: ClinicalTrials.gov · Last updated 16 May 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 152 (actual)
- First submitted
- 12 Jul 2021
- Start date
- 1 Nov 2021
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research Institute
- Diseases
- Multiple sclerosis
- NCT number
- NCT04988880
What you commit to
- Study type: Interventional
- Participants enrolled: 152
- From 1 Nov 2021 to the primary completion date, 31 Dec 2023
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Participants: Expert Patient exclusion criteria without any restriction for healthcare or educational professionals.
Who the study is looking for
- Expert Patient: diagnosis of MS, possibility to attend the sessions and signing of the informed consent.
- Participants: Expert Patient inclusion criteria and need for support for self-management or detection of lack of knowledge regarding MS.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitari Germans Trias i Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Unknown status |
| Center for Neuroimmunology. Advanced Imaging in Neuroimmunological Diseases lab (ImaginEM). Hospital Clinic Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Centre d'Esclerosi Múltiple de Catalunya (Cemcat), Vall d'Hebron Barcelona Hospital Campus Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Unitat de Neuroimmunologia i Esclerosi Múltiple Coordinator of this site? Confirm its status | Girona | Spain | Unknown status |
| Hospital Universitari Arnau de Vilanova Lleida; Institut de Recerca Biomèdica de Lleida (IRBLleida) Coordinator of this site? Confirm its status | Lleida | Spain | Unknown status |
| Hospital Universitari de Tarragona Joan XXIII; Salut Sant Joan de Reus - Baix Camp; Fundació Esclerosi Múltiple - Mas Sabater Coordinator of this site? Confirm its status | Tarragona | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.