eOnOff - D1 Extension
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      Clinical assessments can only offer a snapshot of daily life with Parkinson's Disease, while
      wearable devices can offer immensely more information that can improve the understanding of
      this disease. With recent advancements in technology, investigators are now able to use
      watch-like devices to more effectively measure the symptoms of Parkinson's Disease outside of
      the doctor's office. The present study is designed to evaluate the usability, applicability,
      and interpretability of an electronic VA Patient Motor Diary (eON-OFF), MC10 BioStampRC
      actigraphy sensor, APDM actigraphy sensor and the GENEActiv Watch in persons with Parkinson's
      Disease. There is no placebo/control group.
    

Detailed description: 
      The proposed study will be comprised of at least four sessions in the Spivack Center (Rm.
      X-140) on separate days (not counting recruitment, screening, or consent activities), each
      lasting approximately 1-2 hours. Subjects will commence a 1-week testing period during which
      they will wear the 3 actigraphy devices in their normal schedule and daily environment. On
      Days 2, 3, 4, and 5, subjects will use the eON-OFF motor diary application to select their
      current Parkinson state (e.g. "on", "off"). ON and OFF states are subjective measures
      identified by subjects, and are commonly used words in Parkinson's Disease treatment and
      research to describe symptom states. Symptom severity is directly linked to medication
      effectiveness. "On" is when the medication is working and symptoms are not severe or
      troublesome. "Off" is when medication has worn off, and symptom severity increases. Subjects
      will also use the eON-OFF motor diary application to verbally record symptomology every 30
      minutes while awake. Subjects will complete paper VA Patient Motor Diaries to record ON and
      OFF states on Day 2, Day 3, and Day 4. Subjects will then complete the outlined set of
      activities during Phase I in a second phase to take place approximately one month later. All
      questionnaires, training and interviews will be administered one-on-one by a trained research
      assistant. All UPDRS' will be administered by a clinician. Ideally, subjects will be
      administered the study activities on the days listed above, but they are allowed a
      flexibility of +/- 4 days for scheduling appointments.
    

Intervention name(s): MC10 BioStampRC; APDM actigraphy device; GENEActiv watch
Intervention type(s): Device; Device; Device
Intervention description(s): Subjects will fill out electronic diaries on a provisioned iPhone to capture "On" versus "Off" time on a daily basis while at home. In addition, subjects will be asked to wear three actigraphy devices.; Subjects will fill out electronic diaries on a provisioned iPhone to capture "On" versus "Off" time on a daily basis while at home. In addition, subjects will be asked to wear three actigraphy devices.; Subjects will fill out electronic diaries on a provisioned iPhone to capture "On" versus "Off" time on a daily basis while at home. In addition, subjects will be asked to wear three actigraphy devices.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Individuals diagnosed with Parkinson's disease.
      
Keywords: Wearable device; Patient monitor