MS Multiple Sclerose
Conditions
Interventions
1.6 Interventions for the research groups
1.6.1 Telemonitoring group
Patients in the home monitoring group will record developments / symptoms
related to their MS disease and general health by comple
Sponsors
Isala Klinieken
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: The MS patient is treated in the Isala. Agrees to participate and has signed the ICF. Is 18 years of age or older. Is be prepared to replace 50% of the consultations with video calling. Is be prepared to work with the MSM program. The doctor considers the patient suitable for participation (considering possible underlying suffering) The informal caregiver is the informal caregiver of the MS patient Is over 18 years old Is prepared to participate in the survey and fill in the questionnaires specifically for the informal caregiver.
Exclusion criteria
Exclusion criteria: The patient does not master the Dutch language sufficiently. Patient has insufficient computer skills. Incapacitated adults are excluded from the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measure The primary endpoint (equal or improved MSQoL-54) at which the value of telemonitoring is determined is t = 2 years. If the lower bound of the confidence interval is above the non-inferiority margin (-8), then non-inferiority will be demonstrated. If the lower bound of the confidence interval is above 0, superiority will also be demonstrated. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secundary parameters The secondary outcomes are the endpoints of the study parameters, described in section 4. (page 16) Superiority question (patients): Number of physical outpatient checkups (in hospital) and patient empowerment (IPA, PIH, MSESS and Eq5d) after t = 2 years Number of physical outpatient checks An MS patient comes to the clinic on average 4 times a year; 2x with the neurologist and 2x with the nurse specialist. During this study, every 3 months a record is made of how many physical checks there have been and this value is entered manually in the research manager. Cumulative numbers over the period of 2 years will be compared between research arms by means of mixed model analysis. Patient empowerment This concerns the results of the questionnaires IPA, PIH, MSESS and Eq5d. These endpoints will be analyzed through mixed model analysis, examining both the difference between and within research arms. Non-inferiority research question (informal caregivers): The assessment of the informal care situation, the severity of providing informal care and the degree of happiness of the informal caregiver. Averages and the confidence interval of the difference will be calculated. This analysis is explorative. The outcomes of the Carelqol questionnaire from both groups are compared | — |
Countries
Netherlands
Outcome results
None listed