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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.
Full description
Scope. The study will be carried out in 6 specialized reference units in Catalonia for the group of patients diagnosed with MS. All these units are multidisciplinary reference units in Girona, Barcelona, Tarragona and Lleida for the group of patients diagnosed or suspected of demyelinating disease and specifically MS.
Design. 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 Ethics Committees. 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.
Population. All people with a diagnosis of MS treated in the 6 reference units of Catalonia for people with MS will be eligible to be recruited to participate in the deployment of the PPEC-EM.
Recruitment. The diagnosis and follow-up of patients is carried out in the respective units and involves therapeutic support by the multidisciplinary team in the clinical consultation, the day care clinic or through a spontaneous consultation. Once a clinical visit has been made by a healthcare professional, where lack of knowledge regarding MS or the need for support to perform an effective self-management are detected, patient will be referred to the centre's study coordinator to explain the study, its purpose and to provide complete information to the patient. In case of acceptance, the professional will assess whether IC / EC are met. If so, the study coordinator will ask participants for their informed consent.
Sample size. It is intended to constitute 12 groups of patients (6 for people with remitting and 6 for progressive MS; one of each type per unit). Based on the methodology used in the program, the recruitment target will be 12 subjects per group (144 individuals in total). This is expected to compensate for possible losses during the intervention to ensure a minimum presence of 8-10 subjects per group throughout the program (96-120 individuals).
Study variables Dependents: quality of life, emotional impact, fatigue, activation of the person, knowledge of MS, habits and lifestyles, use of health services (number of primary care visits; number of emergency department visits; number visits unscheduled in the MS unit), medication, nutrition, exercise and program-related experience of the EP and the participants.
Independent variables
Description of the questionnaires and test
Data collection. All variables will be measured pre and post intervention and at 6 and 12 months, so a session will be held in these periods to collect the questionnaires and offer the possibility of clarifying concepts or doubts that may arise regarding the contents of previous sessions. Participants will receive the questionnaires to be filled in at their home by means of the corporate email of the program and these will be returned by the participants by e-mail. At 12 months after the study, the original questionnaires will be collected through a courier service by the PPEC-EM.
Intervention. The study will be conducted virtually due to the current pandemic situation (SARS-CoV-2). For this reason, Teams virtual platform will be used, provided by PPEC managers linked to the Generalitat de Catalunya and for use endorsed by the aforementioned institution. The aim of the intervention is to reinforce positive knowledge in a concise, clear way and with language that can be understood by the participants. (See intervention description for further information).
Analysis of results. Continuous variables will be described with mean and standard deviation (SD) or median and interquartile range (RIQ) in case of non-compliance with normality criteria and categorical variables with absolute frequency and percentages. The non-parametric U Mann-Whitney test for independent samples and the Wilcoxon test for dependent samples will be used to analyze the relationship between a category variable and a numerical variable. The Chi2 test or the Fisher's exact test will be used to analyze the relationship between two category variables. A significance level of 5% will be considered. The data will be analyzed using the SPSS statistical program with the latest version available.
Ethical aspects. The study protocol will be presented to the CEICs of the respective units. The foundations of the Declaration of Helsinki will be respected as well as the current legislation on confidentiality of personal data and the ethical norms on clinical studies, guaranteeing the strict fulfillment of the Law of protection of personal data, in Spain, Organic Law 3/2018, of 5 December, on the Protection of Personal Data and the guarantee of digital rights (BOE 6 December 2018, applicable from 7 December 2018). Participants will not be compensated for their inclusion or follow-up and will be informed of the voluntary nature of their participation, guaranteeing the confidentiality of data. All data collected will be incorporated into a computerized database, where participants will be identified with a code. No data will be shared. Each center will send the results to the HUVH coordinating center, the IP will guard the database. The database will be saved until the analysis is complete.
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152 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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