N/A
Completed N=226
Assessing Tele-Health Outcomes in Multiyear Extensions of PD Trials
Source: ClinicalTrials.gov NCT03538262 ↗Enrolled (actual)
226
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcomePrimary: Change in Tele-visit Modified MDS-UPDRS Parts 1-3 (Total Score) — 2.197; 8.943 score on a scale — p=0.006
Summary
An observational study to characterize and compare long-term clinical outcomes data collected remotely through periodic tele-visits, interactive smartphone app sessions, and web-based surveys in individuals with Parkinson's Disease (PD) who have completed the interventional phases of the STEADY-PD3 and SURE-PD3 clinical trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Tele-visit Modified MDS-UPDRS Parts 1-3 (Total Score) |
2.197; 8.943 | 0.006 sig |
| PRIMARY Change in Tele-visit MDS-UPDRS Part 2 (Score) |
0.575; 1.550 | 0.011 sig |
| PRIMARY Change in Smartphone Tapping (Score) |
-0.051; -0.088; -0.057; -0.078; -0.106; -0.116 | 0.007 sig |
| PRIMARY Change in Fox Insight MDS-UPDRS Part 2 (Score) |
-0.002; 1.027; 1.367; 1.771 | 0.996 |
| SECONDARY Change in Tele-visit MDS-UPDRS Part 1a (Score) |
0.189; 0.313 | 0.145 |
| SECONDARY Change in Tele-visit MDS-UPDRS Part 1b (Score) |
1.026; 1.238 | <.001 sig |
| SECONDARY Change in Tele-visit Modified MDS-UPDRS Part 3 (Score) |
0.457; 4.617 | 0.382 |
| SECONDARY Change in Tele-visit Montreal Cognitive Assessment (MoCA; Score) |
-0.051; 0.142 | 0.688 |
| SECONDARY Change in Tele-visit Schwab and England (S&E; Score) |
-0.440; -0.338 | 0.446 |
| SECONDARY Change in Tele-visit Clinician Global Impression - Severity (CGIS; Score) |
0.103; 0.004 | 0.006 sig |
| SECONDARY Change in Fox Insight Parkinson's Disease Questionnaire - 8 Item Version (PDQ-8; Score) |
0.396; 0.637; 1.258; 1.113; 1.687; 1.543 | 0.041 sig |
| SECONDARY Change in Fox Insight EuroQol Five Dimensions Questionnaire (EQ-5D; Score) |
-0.010; -0.015; 0.003; -0.040 | 0.595 |
| SECONDARY Change in Fox Insight Non-motor Symptoms Questionnaire (NMS-QUEST; Score) |
0.447; 1.062; 1.432; 1.323; 1.642; 1.720 | 0.074 |
| SECONDARY Change in Fox Insight REM (Rapid Eye Movement) Behavior Disorder (RBD; Score) |
-0.125; -0.008; 0.020; 0.088; -0.117; 0.148 | 0.200 |
| SECONDARY Change in Fox Insight Parkinson's Daily Activities Questionnaire -15 (PDAQ-15; Score) |
0.611; -0.798; -0.400; -1.618 | 0.285 |
| SECONDARY Change in Fox Insight Geriatric Depression Scale (GDS; Score) |
0.401; 0.855 | 0.409 |
Eligibility Criteria
Inclusion Criteria
- Enrollment in STEADY-PD3 or SURE-PD3 studies
- Prior consent to be contacted by the University of Rochester (UR) or if a participant from STEADY-PD III or SURE-PD3 studies directly contacts UR to request information about study participation
- Internet-enabled device that will support participation in tele-visits
- Have created or willing to create a Global Unique Identifier (GUID)
- Willing and able to provide informed consent
- English fluency
- For participants opting to participate in the smartphone component, possession of a suitable smartphone (iPhone or Android) with adequate data plan and cellular network access/signal or wifi access
Exclusion Criteria
- Inability to carry out study activities as determined by study staff
Data sourced from ClinicalTrials.gov (NCT03538262). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.