Telemonitoring and connected care applied to Multiple Sclerose: Effect on quality of life
- Conditions
- MS10012303Multiple Sclerose
- Registration Number
- NL-OMON50143
- Lead Sponsor
- Isala Klinieken
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 208
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.
The patient does not master the Dutch language sufficiently.
Patient has insufficient computer skills.
Incapacitated adults are excluded from the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary outcome measure<br /><br>The primary endpoint (equal or improved MSQoL-54) at which the value of<br /><br>telemonitoring is determined is t = 2 years.<br /><br>If the lower bound of the confidence interval is above the non-inferiority<br /><br>margin (-8), then non-inferiority will be demonstrated. If the lower bound of<br /><br>the confidence interval is above 0, superiority will also be demonstrated.</p><br>
- Secondary Outcome Measures
Name Time Method