N/A
Completed N=304
Real-PD Trial: Development of Clinical Prognostic Models for Parkinson's Disease
Source: ClinicalTrials.gov NCT02474329 ↗Enrolled (actual)
304
Serious AEs
0.0%
Results posted
Dec 2021
Primary outcomePrimary: Parkinson's Disease Symptoms — 52.5 units on a scale
Summary
Background: Long-term management of Parkinson's disease (PD) does not reach its full potential due to lack of knowledge about disease progression. The Real-PD study aim to evaluate the feasibility and compliance of usage of wearable sensors in PD patients in real life. Moreover, an explorative analysis concerning activity level, medication intake and mood will be done.
Methods: Overall, 1000 PD patients and 250 physiotherapist will be enrolled in this observational study. Dutch PD patients will be recruited across the country and an assessment will be performed using a short version of the Parkinson's Progression Markers Initiative (PPMI) protocol. Moreover, participants will wear a set of medical devices (Pebble Smartwatch, fall detector) and they will use a smartphone with The Fox Insight App (Android app), 24/7, during 13 weeks. Primary measures of interest are: 1) physical activity, falls and tremor, measured by the axial accelerometers embedded in the Pebble watch and fall detector; and 2) medication intake and mood reports measured by patients' self-report in the Android app. To measure motor impact, an assessment will be performed by physiotherapists who are all certified to perform the Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS).
Discussion: Management of PD patients is complex and appears to be a challenging task for health care professionals. The main reason is the lack of knowledge in the disease pattern. This issue could be solved by a long term follow-up of patients' during their everyday life, and wearable medical devices can act as a way to collect data about every day life activities. Therefore, the Real-PD study will be a first contribution in increasing the lack of knowledge in disease progression, developing a new medical decision system and improving PD patients' care.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Parkinson's Disease Symptoms |
52.5 | — |
| PRIMARY Depression Scores as a Measure of Depression Rates |
238; 53 | — |
| PRIMARY Cognitive Impairment. |
125; 166 | — |
| PRIMARY Independency Level |
36; 51; 109; 41; 54 | — |
| SECONDARY Number of Falls Per Patient Registered by the Falls Detector. |
— | — |
| SECONDARY Number of Mood Reports for Each Patient Measured With a Four Point Scale |
— | — |
| SECONDARY Number of Medication Intake Annotations Made by Each Participant Via the Self-report App. |
351 | — |
| SECONDARY Time That Each Patient Was Active During the Day |
72 | — |
| SECONDARY Level of Activity for Each Patient During the Day |
— | — |
| SECONDARY Scores in Autonomic Dysfunctions Measure With the Autonomic Dysfunctions Scale |
17.2 | — |
| SECONDARY Sleepiness Rates in the Epworth Sleepiness Scale as a Measure of Sleep Quantity. |
6.0 | — |
Eligibility Criteria
Inclusion Criteria
- Currently own and use a smartphone device with access to the Internet
- 30 years of age or older;
- Diagnosed with Parkinson's disease by a physician;
- Able to walk without any assistance.
Exclusion Criteria
None exclusion criteria will be used.
Data sourced from ClinicalTrials.gov (NCT02474329). 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.