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

Primary Purpose

Parkinson Disease, Apathy

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Gameficiation

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Physical Activity, Social Incentives, Behavioral Economics, Goal-Directed Behavior, Motivation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

University of Pennsylvania's Parkinson's Disease and Movement Disorder Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Gameification Arm

Education Arm

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Effectiveness of gameification intervention to improve physical activity levels

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.

Ability of behavioral phenotyping to predict step goal achievement

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.

Ability of behavioral phenotyping to predict change in activity

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04051151

First Posted

July 26, 2019

Last Updated

February 7, 2023

Sponsor

University of Pennsylvania

1. Study Identification

Unique Protocol Identification Number

NCT04051151

Brief Title

Move to Improve Physical Activity in Parkinson's Disease

Acronym

MoTIvatE

Official Title

Move to Improve Physical Activity in Parkinson's Disease: MoTIvatE PD

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

August 26, 2019 (Actual)

Primary Completion Date

January 1, 2020 (Actual)

Study Completion Date

December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson Disease, Apathy

Keywords

Physical Activity, Social Incentives, Behavioral Economics, Goal-Directed Behavior, Motivation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

84 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Gameification Arm

Arm Type

Experimental

Arm Description

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

Arm Title

Education Arm

Arm Type

No Intervention

Arm 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.

Intervention Type

Behavioral

Intervention Name(s)

Gameficiation

Intervention Description

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.

Primary Outcome Measure Information:

Title

Effectiveness of gameification intervention to improve physical activity levels

Description

Time Frame

Four weeks

Title

Ability of behavioral phenotyping to predict step goal achievement

Description

Time Frame

Four weeks

Title

Ability of behavioral phenotyping to predict change in activity

Description

Time Frame

Four weeks

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nabila Dahodwala, MD

Organizational Affiliation

University of Pennsylvania

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Pennsylvania's Parkinson's Disease and Movement Disorder Center

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

16207933

Citation

Levy R, Dubois B. Apathy and the functional anatomy of the prefrontal cortex-basal ganglia circuits. Cereb Cortex. 2006 Jul;16(7):916-28. doi: 10.1093/cercor/bhj043. Epub 2005 Oct 5.

Results Reference

background

PubMed Identifier

1627973

Citation

Starkstein SE, Mayberg HS, Preziosi TJ, Andrezejewski P, Leiguarda R, Robinson RG. Reliability, validity, and clinical correlates of apathy in Parkinson's disease. J Neuropsychiatry Clin Neurosci. 1992 Spring;4(2):134-9. doi: 10.1176/jnp.4.2.134.

Results Reference

background

PubMed Identifier

18801696

Citation

Pedersen KF, Larsen JP, Alves G, Aarsland D. Prevalence and clinical correlates of apathy in Parkinson's disease: a community-based study. Parkinsonism Relat Disord. 2009 May;15(4):295-9. doi: 10.1016/j.parkreldis.2008.07.006. Epub 2008 Sep 17.

Results Reference

background

PubMed Identifier

20175757

Citation

Leiknes I, Tysnes OB, Aarsland D, Larsen JP. Caregiver distress associated with neuropsychiatric problems in patients with early Parkinson's disease: the Norwegian ParkWest study. Acta Neurol Scand. 2010 Dec;122(6):418-24. doi: 10.1111/j.1600-0404.2010.01332.x.

Results Reference

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