Parkinson's Disease Personalized Care Application iPD

Parkinson’s disease (PD) is a disabling neurodegenerative condition that affects motor functions causing tremors, slowed shuffling gait, and falls. The symptoms of PD and the effects of medication fluctuate throughout the day. Therefore, multiple doses of Carbidopa/Levodopa are administered throughout the day for symptomatic management. Moreover, patients may experience “on periods”, when the medication is working alternating with “off periods”, when the medication wears off causing impaired motor coordination, shuffling gait, and falls.

Currently, there is a need for an objective, validated, digital measure to assess motor outcomes (such as mobility and gait, fall risk), continuously for patients with Parkinson’s disease (PD) to capture these fluctuations and optimize treatment ^(1,2). There are multiple sensors available currently that can gather continuous data remotely and passively, provide information on how well patients are functioning in their naturalistic environment, evaluate the impact of any recent medication/intervention, and identify the need for intervention before a catastrophic fall for e.g. ^(3,4)

There has been a study that has demonstrated feasibility and acceptability of using Android smartphones and pebble smartwatches, Fox wearable companion app, and Intel Pharma Analytics Platform for patients with PD. However, the Pebble smartwatch is no longer available. Currently, available devices, the Apple Watch and iPhone can collect precise, quantitative data on gait and tremor equivalent to medical-grade sensors ^(5,6,7). In addition to these metrics, medication time, and compliance logs, patient questionnaires can be captured on the iPhone via Apple HealthKit.

Inclusion Criteria:

1) Participants with a diagnosis of PD or primary Parkinsonism> 18 years of age, who can ambulate (Hoehn and Yahr stages 1-4). The diagnosis of PD or primary Parkinsonism needs to be confirmed by a neurologist.

2) Participants agreeable to and able to wear an Apple watch for at least 12 hours a day between 7 am to 10 pm for 2 weeks.

3) Participants agreeable to and able to carry an iPhone around the waist (such as in the pocket of their pants/ around the belt) for at least 8 hours during the day between 7 am to 10 pm for 2 weeks.

4) Participants or their family members be able to log in and tap “medication taken or skipped” on the app medication notification feature on their iPhone or watch.

5) Participants are willing to complete a questionnaire focused on their “on and off states”, daily activities, and other symptoms once during the 2 weeks.

6) Participants consenting and agreeable to downloading the PD companion app for data transfer on gait metrics and medications collected during the 2 weeks of the study to be transferred, stored, and used by the study team for research purposes.

7) Able to read, speak, and understand English.

8) Has an iPhone (iPhone SE 3^rd generation or iPhone XS or higher version).

Exclusion Criteria:

1) Participants with PD who are unable to ambulate, are bedbound or wheelchair-bound (Hoehn and Yahr stage 5).

2) Participants unable or unwilling to wear an Apple watch or carry an iPhone for an extended period as listed in the Inclusion criteria.

3) Participants who are not able or unwilling to operate an iPhone or are unable to complete diaries/ questionnaires.

4) Participants not able to or unwilling to provide informed consent or agreeable to data (specific to the study) transfer to the study team.

5) Participants who do not speak English.

6) Does not have an iPhone (iPhone SE 3^rd generation or iPhone XS or higher version)