TY - JOUR
T1 - MSmonitor-plus program and video calling care (MPVC) for multidisciplinary care and self-management in multiple sclerosis
T2 - study protocol of a single-center randomized, parallel-group, open label, non-inferiority trial
AU - Hoving, M.
AU - Jongen, P. J.
AU - Evers, S. M.A.A.
AU - Edens, M. A.
AU - Zeinstra, E. M.P.E.
N1 - Funding Information:
We would like to thank the MS foundation of the Netherlands and Innovation and science foundation Isala for funding the study. Furthermore, we would like to thank the members of the MS study team, Mrs. Mireille Warrink for managing the program the ResearchManager and Mrs. Ria van de Veen for scientific editing of this paper.
Funding Information:
The study is funded by the MS Foundation, Rotterdam, The Netherlands, number OZ2020–001 and the Innovation & Science Foundation of Isala, number 20.015, Zwolle, The Netherlands.
Publisher Copyright:
© 2022, The Author(s).
PY - 2022/12
Y1 - 2022/12
N2 - Background: We designed a new multi-modal version of the MSmonitor, called the MSmonitor-Plus and Video calling Care (MPVC), a self-management and education program with e-health interventions that combines frequent use of specific questionnaires with video calling in treating multiple sclerosis (MS) patients.Objective: To assess the effectiveness, cost-effectiveness and feasibility of MPVC compared to care as usual (CAU), with the goal of achieving equal or better quality of life for MS patients and their partners/informal caregivers.Our hypothesis is that by using MPVC, monitoring will become more efficient, that patients’ self-efficacy, quality of life, and adherence to treatment will improve, and that they will be able to live their lives more autonomously.Methods: A randomized, parallel-group, open label, non-inferiority trial will be conducted to compare MPVC with CAU in MS patients and their partners/informal caregivers. A total of 208 patients will be included with follow-up measurements for 2 years (at baseline and every 3 months). One hundred four patients will be randomized to MPVC and 104 patients to CAU. Partners/informal caregivers of both groups will be asked to participate.The study will consist of three parts: 1) a clinical effectiveness study, 2) an economic evaluation, and 3) a process evaluation. The primary outcome relates to equal or improved disease-specific physical and mental quality of life of the MS patients. Secondary outcomes relate to self-efficacy, efficiency, cost-effectiveness, autonomy, satisfaction with the care provided, and quality of life of partners/informal caregivers.Discussion: The idea behind using MPVC is that MS patients will gain more insight into the individual course of the disease and get a better grip on their symptoms. This knowledge should increase their autonomy, give patients more control of their condition and enable them to better and proactively interact with health care professionals.As the consulting process becomes more efficient with the use of MPVC, MS-related problems could be detected earlier, enabling earlier multidisciplinary care, treatment or modification of the treatment. This could have a positive effect on the quality of life for both the MS patient and his/her partner/informal caregiver, reducing health and social costs.Trial registration: NCT05242731 Clinical Trials.gov. Date of registration: 16 February 2022 retrospectively registered.
AB - Background: We designed a new multi-modal version of the MSmonitor, called the MSmonitor-Plus and Video calling Care (MPVC), a self-management and education program with e-health interventions that combines frequent use of specific questionnaires with video calling in treating multiple sclerosis (MS) patients.Objective: To assess the effectiveness, cost-effectiveness and feasibility of MPVC compared to care as usual (CAU), with the goal of achieving equal or better quality of life for MS patients and their partners/informal caregivers.Our hypothesis is that by using MPVC, monitoring will become more efficient, that patients’ self-efficacy, quality of life, and adherence to treatment will improve, and that they will be able to live their lives more autonomously.Methods: A randomized, parallel-group, open label, non-inferiority trial will be conducted to compare MPVC with CAU in MS patients and their partners/informal caregivers. A total of 208 patients will be included with follow-up measurements for 2 years (at baseline and every 3 months). One hundred four patients will be randomized to MPVC and 104 patients to CAU. Partners/informal caregivers of both groups will be asked to participate.The study will consist of three parts: 1) a clinical effectiveness study, 2) an economic evaluation, and 3) a process evaluation. The primary outcome relates to equal or improved disease-specific physical and mental quality of life of the MS patients. Secondary outcomes relate to self-efficacy, efficiency, cost-effectiveness, autonomy, satisfaction with the care provided, and quality of life of partners/informal caregivers.Discussion: The idea behind using MPVC is that MS patients will gain more insight into the individual course of the disease and get a better grip on their symptoms. This knowledge should increase their autonomy, give patients more control of their condition and enable them to better and proactively interact with health care professionals.As the consulting process becomes more efficient with the use of MPVC, MS-related problems could be detected earlier, enabling earlier multidisciplinary care, treatment or modification of the treatment. This could have a positive effect on the quality of life for both the MS patient and his/her partner/informal caregiver, reducing health and social costs.Trial registration: NCT05242731 Clinical Trials.gov. Date of registration: 16 February 2022 retrospectively registered.
KW - MSmonitor
KW - MSmonitor-plus
KW - Multiple sclerosis
KW - Quality of life
U2 - 10.1186/s12883-022-02948-z
DO - 10.1186/s12883-022-02948-z
M3 - Article
C2 - 36371162
AN - SCOPUS:85141706668
SN - 1471-2377
VL - 22
JO - BMC NEUROLOGY
JF - BMC NEUROLOGY
M1 - 423
ER -