Parkinson Smartwatch Cost and Efficacy Study

• Conditions: Parkinson disease; 10028037

• Registration Number: NL-OMON48249
• Lead Sponsor: Parkinson Smartwatch b.v.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

Parkinson's disease with response fluctuations with dyskinesia

Exclusion Criteria

dementia

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary: the percentage of good hours, i.e. the total time without *off* or<br /><br>*dyskinesia* (moderate or severe).<br /><br>This covers the *middle green third* of the VAS at the smartwatch [which<br /><br>indicates OK, slightly off, or slight dyskinesia].<br /><br>Rationale: while Parkinson Smartwatch produces data which allow improvement of<br /><br>the treatment plan, these same data also provide a solid image of the quality<br /><br>of life.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary: the number of patients who had an advanced therapy within the study<br /><br>period; the percentage of patients with a score of 7 or higher in a 10 point<br /><br>VAS score about user satisfaction; the number of dropouts; the number of<br /><br>patients who consider an advanced therapy after the study period; cost at end<br /><br>versus start. The percentage of patients where the neurologist indicates the<br /><br>usefulness of accelerometery >6.5 on a VAS of 1 to 10. Side effects and<br /><br>tolerability. User satisfaction of the doctor.</p><br>