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Move to Improve Physical Activity in Parkinson's Disease (MoTIvatE)

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ClinicalTrials.gov Identifier: NCT04051151
Recruitment Status : Active, not recruiting
First Posted : August 9, 2019
Last Update Posted : January 14, 2021
Sponsor:
Information provided by (Responsible Party):
Nabila Dahodwala, MD, University of Pennsylvania

Brief Summary:

Apathy is a multi-dimensional behavior characterized by impairments to motivation, planning and initiation; collectively called, goal-directed behavior. It is highly prevalent in patients suffering from neurological disorders such as Alzheimer's disease and Parkinson's disease (PD) as well as psychiatric disorders such as depression and schizophrenia. In PD, specifically, apathy is one of the more troublesome symptoms. Apathetic PD patients have greater disability, lower adherence to treatment plans and caregivers report greater stress and burden.

Interventions grounded in behavioral economic theories, namely, financial and social incentives often promote positive behavioral change such as weight loss and smoking cessation. However, the effectiveness of these interventions varies across and within conditions and incentive type. It also tends to dissipate when incentives are no longer provided. To date, these approaches have not been used to promote behavior change in PD or other neurological conditions where apathetic behaviors are a pressing problem. The overall goal of this study is to test if behavioral economic approaches will reduce apathy, and subsequently, improve goal-directed behavior in Parkinson's disease.


Condition or disease Intervention/treatment Phase
Parkinson Disease Apathy Behavioral: Gameficiation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Move to Improve Physical Activity in Parkinson's Disease: MoTIvatE PD
Actual Study Start Date : August 26, 2019
Actual Primary Completion Date : January 1, 2020
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Gameification Arm
Participants and partners that have randomized to the gamification group will receive instructions and help in setting up a game.
Behavioral: Gameficiation
Participants and partners that have randomized to the gamification group will receive instructions and help in setting up a game platform via Way to Health. This game will include wearing a Fit Bit device, setting a daily step goal, and point deductions for failure to meet this step goal throughout the following 4 weeks. Participants will move up or down specified levels each week depending on how many days they met their step goal.

No Intervention: Education Arm
Participants and partners that randomized to the control group will receive standard of care educational resources on the importance of physical activity in Parkinson's patients.



Primary Outcome Measures :
  1. Effectiveness of gameification intervention to improve physical activity levels [ Time Frame: Four weeks ]
    To test the feasibility and preliminary effectiveness of a gamification intervention that enhances supportive social incentives that includes collaboration, accountability and peer support to improve physical activity levels compared to a control group that receives the standard of care. The researchers will compare the change in mean daily steps between the gameification and control (education) groups using an independent t-test.

  2. Ability of behavioral phenotyping to predict step goal achievement [ Time Frame: Four weeks ]
    Among participants in the intervention group, the researchers will compare the number of days that step goals were achieved between individuals with greater motivation deficits and those with initiation and planning deficits using a one-way independent ANOVA.

  3. Ability of behavioral phenotyping to predict change in activity [ Time Frame: Four weeks ]
    Among participants in the intervention group, the researchers will compare the change in mean daily steps between individuals with greater motivation deficits and those with initiation and planning deficits using a one-way independent ANOVA.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Eligible participants will have a diagnosis of Parkinson's disease, and may have either normal cognition or mild cognitive impairment (MCI). Most eligible participants will have to have smartphones with wifi, application, Bluetooth, and text messaging capabilities. The study team does have five smart phone that can be provided to participants who do not have smartphones so as to not exclude these individuals.
  • Eligible participants will have to be mobile as the primary outcome measure for the study is step goals measured on the Fitbit. Participants will be eligible if they can ambulate successfully with a cane.
  • Participants will also need a study partner to be eligible to participant. This partner can be anyone of the eligible participant's choosing, who also consents to participation in the study.

Exclusion Criteria:

  • Individuals will be excluded if they screen positive for dementia at the screening visit or do not have the decisional capacity to give consent. Dementia will be defined as a Montreal Cognitive Assessment (MoCA) score of <22. Decisional capacity will be tested based on their understanding of study risks and benefits.
  • Individuals will also be excluded if they require a wheelchair or walker, or are unable to ambulate safely.
  • Individuals will be excluded if they are currently participating in another physical activity study, have been told by a physician not to exercise, or are currently pregnant.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04051151


Locations
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United States, Pennsylvania
University of Pennsylvania's Parkinson's Disease and Movement Disorder Center
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: Nabila Dahodwala, MD University of Pennsylvania
Publications:
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Responsible Party: Nabila Dahodwala, MD, Associate Professor of Neurology, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT04051151    
Other Study ID Numbers: MoTIvatEPD
First Posted: August 9, 2019    Key Record Dates
Last Update Posted: January 14, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nabila Dahodwala, MD, University of Pennsylvania:
Physical Activity
Social Incentives
Behavioral Economics
Goal-Directed Behavior
Motivation
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases