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

University of Pennsylvania

Status: Completed

Conditions: Apathy; Parkinson Disease

Treatments: Behavioral: Gameficiation

Study type: Interventional

Funder types: Other

Identifiers

NCT04051151

MoTIvatEPD

Details and patient eligibility

About

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.

Enrollment: 84 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

Gameification Arm

Experimental group

Description:

Participants and partners that have randomized to the gamification group will receive instructions and help in setting up a game.

Treatment:

Behavioral: Gameficiation

Education Arm

No Intervention group

Description:

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.