NCT05529121|Completed
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Sponsor study identifier
observational
88
1 country
1
Study Start
December 3, 2021
Actual (reported)Primary Completion
July 1, 2024
Actual (reported)Study Completion
July 1, 2024
Actual (reported)Under a grant from the Department of Defense's PD program, Dr. Morley's is investigating new approaches that 1) use "gamification"- applying rules of games like point scoring, achieving silver, gold or platinum levels and competition-- to increase physical activity in PD; 2) identify whether certain PD patient respond differently to gamification interventions than others.; 3) use readily and commercially available (including Fitbits) digital health technologies to perform all study activities remotely and enable a "touchless" study where patients don't have to come in person for any studies visits. The study is underway and actively recruiting.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 1, 2024
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 3, 2021
Actual (reported)September 1, 2022
Actual (reported)September 6, 2022
Actual (reported)July 1, 2024
Actual (reported)July 1, 2024
Actual (reported)Determine the feasibility and acceptability of a "touchless" intervention to increase physical activity in patients with PD using digital health technology and behavioral economics strategies
Protocols using gamification to increase physical activity in patients with PD employing remote intervention and assessment will be feasible and acceptable to participants. Specifically we hypothesize that subjects will: H1a) wear their activity monitor ≥ 80% of the time; H1b) successfully create a remote monitoring account and sync their device; H1c) wear and capture motor symptoms with the PKG and H1d) report high program acceptability (Intrinsic Motivation Inventory score ≥ 5)
2026
Determine whether non-motor features predict responsiveness to a behavioral economic-based gamification intervention to increase physical activity in patients with PD
Non-motor and features, in particular risk aversion as measured by the DOSPERT scale, will be associated with change in daily step count during the gamification intervention
2026
Determine whether changes in physical activity in response to a gamification intervention impact PD motor symptoms measured using a remotely-monitored wearable device
Increased activity during the gamification intervention will be associated with improvement of motor scores remotely measured using the Parkinson's Kineticgraph (PKG)
2026
Veteran participants within the VISN4 region (a network of 9 VA medical centers and 45 outpatient clinics, covering Pennsylvania, Delaware and parts of Ohio, West Virginia, New York and New Jersey).
Corporal Michael J. Crescenz VA Medical Center
Philadelphia, Pennsylvania, 19104, United States
James Morley
Corporal Michael J. Crescenz VA Medical Center
88 participants (actual enrollment reported by the registry).
First Submitted
September 1, 2022
First Posted
September 6, 2022
Study Start
December 3, 2021
Actual (reported)High Fiber in Parkinson's Disease
Contact the study team to confirm eligibility.
Primary Completion
July 1, 2024
Actual (reported)Study Completion
July 1, 2024
Actual (reported)Last Updated
July 29, 2024
Record last verified: 2024-07
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Source: ClinicalTrials.gov.
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