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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04988880
Other study ID # PR(AG)334/2021
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 1, 2021
Est. completion date July 31, 2024

Study information

Verified date October 2022
Source Hospital Universitari Vall d'Hebron Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Intervention

Other:
Multiple Sclerosis Expert Patient Program of Catalonia
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.

Locations

Country Name City State
Spain Hospital Universitari Germans Trias i Pujol Badalona Barcelona
Spain Center for Neuroimmunology. Advanced Imaging in Neuroimmunological Diseases lab (ImaginEM). Hospital Clinic Barcelona Barcelona
Spain Centre d'Esclerosi Múltiple de Catalunya (Cemcat), Vall d'Hebron Barcelona Hospital Campus Barcelona
Spain Unitat de Neuroimmunologia i Esclerosi Múltiple Girona
Spain Hospital Universitari Arnau de Vilanova Lleida; Institut de Recerca Biomèdica de Lleida (IRBLleida) Lleida
Spain Hospital Universitari de Tarragona Joan XXIII; Salut Sant Joan de Reus - Baix Camp; Fundació Esclerosi Múltiple - Mas Sabater Tarragona

Sponsors (1)

Lead Sponsor Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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. Multiple Sclerosis Quality of Live - 54 items (MSQoL-54) (Vickrey, Hays, Harooni, Myers, & Ellison, 1995) and its Spanish adaptation by Aymerich in 2006 (Aymerich et al., 2006). It is a self-administered questionnaire, filled in approximately 15 minutes. It consists of 54 items, 36 correspond to the generic SF-36 questionnaire and the remaining 18 are specific to MS. The items are distributed in 12 dimensions and 2 individual items that measure changes in health status (comparison between current health and previous year) and satisfaction with sexual function. In addition, two subtotals corresponding to two scales are obtained: mental and physical health. 18 months from recruitment
Secondary 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. The Hospital Anxiety and Depression Scale (HADS) (Zigmond & Snaith, 1983) and the Catalan version made by Soto in 2018 (Soto, Gras, & Planes, 2008) is a specific instrument for detecting the level of anxiety or depression of an individual in the last 7 days. It consists of a self-administered questionnaire of 14 items, 7 corresponding to the anxiety subscale and 7 to the depression subscale. Each of the items has a rating from 0 to 3 (0 being the minimum affectation and 3 the maximum). A score from 0 to 7 indicates no disorder, 8 to 10 is a questionable case, and ratings above 11 clearly indicate the presence of anxiety or depressive disorder respectively. 18 months from recruitment
Secondary 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. The Fatigue Severity Scale (FSS) (Krupp, LaRocca, Muir-Nash, & Steinberg, 1989) and its Spanish translation by Tola in 1998 (Tola, Yugueros, Fernández-Buey, & Fernández-Herranz, 1998) is an instrument that assesses the impact of fatigue on a person's daily life. It consists of a self-administered questionnaire of 9 items, each with a rating from 1 to 7 (with 1 strongly disagreeing and 7 strongly disagreeing). 18 months from recruitment
Secondary 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. The 13-item Patient Activation Measure (PAM-13) and its validation in Spanish by Moreno-Chico in 2017 (Moreno-Chico et al., 2017) is an instrument that assesses knowledge, skills and people's confidence in self-management of their health and medical care. It consists of a self-administered questionnaire of 13 items, each with a rating from 1 to 4 (with 1 strongly disagreeing and 4 strongly disagreeing). The PAM-13 identifies four stages of activation of the individual. 18 months from recruitment
Secondary 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. The panel of experts of the Expert Patient Program of Catalonia® (PPEC) developed a specific questionnaire about the knowledge of MS that includes information related to the disease and specific aspects identified by the target population through a study of focus groups (Robles-Sanchez et al., 2020) identified as essential to empower themselves regarding the health condition. This questionnaire will assess the impact of the program on the knowledge acquired. 18 months from recruitment
Secondary Change in individuals habits and lifestyles measured by the PPEC specific questionnaire about the habits and lifestyles from beginning of the intervention to end of intervention (9 weeks) and compared to 6 and 12 months after the end of the intervention. The PPEC coordinating panel developed a specific questionnaire to assess habits and lifestyles, this questionnaire has already been used in other variants of the program demonstrating its usefulness in assessing changes due to participation in this program. 18 months from recruitment
Secondary Change in the use of the care services from 1 year pre-intervention to end of intervention (9 weeks) compared to end of intervention (9 weeks) and 12 months after the end of the intervention. Use of health services according electronic clinical reports including number of primary care visits, number of emergency department visits, number visits unscheduled in the MS unit. 18 months from recruitment
Secondary Change in Patient Reported Experience measured from the end of intervention (9 weeks) to 12 months after the end of the intervention. The panel of experts of the Expert Patient Program of Catalonia (PPEC) developed a specific questionnaire about the Patient Reported Experience that includes information related to the experience lived by individuals regarding the programme. This questionnaire will assess the experience of individuals regarding the intervention. 18 months from recruitment
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