Home-Based Monitoring in Parkinson's Disease
NCT Number: NCT06573762
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Parkinson Disease
Sponsor: Jacob E. Simmering
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-01
Completion Date: 2028-01-01
Locations: University of Iowa Hospitals and Clinics, Iowa City, Iowa, 52242, United States

Summary:
The goal of this observational study is to learn about the usefulness of automated analysis of speech, physical activity measures tracked using wearable devices at home, and tremor detection measured using computer-vision analysis of smartphone video to detect impairments related to Parkinson's disease and improve prediction of one-year progression.

Participants will attend a short research visit at the University of Iowa. During this visit, they will make a video recording using a smartphone of them performing a fine motor task and audio recordings of pre-written text. They will be provided with an activity tracker and asked to wear it at home for four weeks. After four weeks, a video visit will be conducted and the speech and video tasks will be repeated.

Primary Outcome Measures: Number of Patients with a Diagnosis of Parkinson's Disease, Among Group 1 (those newly referred to the clinic for possible Parkinson's disease), a primary outcome will be whether the diagnosis made by the provider in the clinic was Parkinson's disease versus any other diagnosis.

This is not an outcome for Group 2 (those with a recent diagnosis of Parkinson's disease) as everyone in that group will have that diagnosis., Baseline|Change in Fine Motor Function, Motor function will be evaluated using the UPDRS rating system., Baseline, One Year|Change in Total Cognition Composite Function, Total Cognition Composite will be calculated using the NIH Toolbox Cognition Battery. This score has a range from 0 to 200 with healthy adults having a mean score of 100 with a standard deviation of 15. Higher scores are associated with better cognitive performance., Baseline, One Year|Change in Total Crystallized Cognition Function, Crystallized Cognition Composite will be calculated using the NIH Toolbox Cognition Battery. This score has a range from 0 to 200 with healthy adults having a mean score of 100 with a standard deviation of 15. Higher scores are associated with better cognitive performance., Baseline, One Year|Change in Total Fluid Cognition Function, Fluid Cognition Composite will be calculated using the NIH Toolbox Cognition Battery. This score has a range from 0 to 200 with healthy adults having a mean score of 100 with a standard deviation of 15. Higher scores are associated with better cognitive performance., Baseline, One Year|Change in Montreal Cognitive Assessment Scores, The Montreal Cognitive Assessment (MoCA) has a range of 0-30. Higher scores are associated with better cognitive function. Scores of 26 or higher are considered cognitively normal. Scores less than 26 are suggestive of cognitive impairment, with dementia scores being below 20 but without a universally-accepted cutoff., Baseline, One Year
Secondary Outcome Measures: Change in Short Form Survey 20 (SF-20) Health Quality of Life, Health related quality of life will me measured using the Short Form Survey 20 (SF-20). SF-20 scores range from 0 to 100 with higher scores having greater quality-of-life., Baseline, One Year|Change in Parkinson's Disease Questionnaire 39 (PDQ-39) Quality of Life, Health related quality of life will me measured using the Parkinson's Disease Questionnaire 39 (PDQ-39). PDQ-39 scores range from 0 to 156 with lower scores reflecting less Parkinson's disease burden and higher scores associated with greater disease burden., Baseline, One Year