Multiaxial data integration for continuous therapy adaption in neurological movement disorders and deep brain stimulation - substudy: patient reported outcomes via app

• Conditions: G20; Parkinson disease

• Registration Number: DRKS00023424
• Lead Sponsor: Charité Campus Charité Mitte

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-25
• Study Completion: 2024-05-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

definite diagosis of parkinsons disease
- privately owned smartphone (Android or iOS operating system) and basic knowledge in using apps
- able to understand study conditions and questiones asked in patient questionnaires

Exclusion Criteria

- cognitive deficites, that obviate fulfilling the inclusion criteria
- comorbidities, whose influence on quality of life exceeds the influence of parkinsons disease considerably as rated by the study physician

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation coefficient with confidence interval between self-rated mobility on visual analogue scale within 2 weeks before study visit and MDS-UPDRS-III at the day of visit.<br>Observation for 6 to 24 months per patient.<br>Analysis: random intercept model

Secondary Outcome Measures

Name	Time	Method
1) Correlation between self-rated general condition and QoL in PDQ-39-score as well as between step count and self-rated mobility (similar analysis to primary endpoint).<br>2) Sensitivity, specificity and predicitve values between gold standard (relevant deterioration/no relevant deterioration as determined in clinials visit) and independent variable (estimation from smartphone data).<br>3) Association between severity of clinical deterioration estimated in clinical visit or in smartphone app.<br>4) Changes in self-rating after therapeutic interventions.