Parkinson Smartwatch Cost and Efficacy Study

Parkinson Smartwatch Cost and Efficacy Study - Parkinson Smartwatch Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON48249

Enrollment

Registered

2019-10-04

Start date

2019-10-01

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson disease

Interventions

to use the Parkinson smartwatch for 6 months

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Parkinson's disease with response fluctuations with dyskinesia

Exclusion criteria

Exclusion criteria: dementia

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)