Motivational Interviewing and Physical Activity Change in Parkinson's Disease

Study Overview
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Brief Summary
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The purpose of this study is to test the efficacy of a 6-month telephone-based motivational interviewing intervention and a web-based application intervention to improve physical activity in participants with Parkinson's Disease.

Detailed Description
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Participants will be randomized into one of four groups to examine two separate interventions. The groups are: motivational interviewing (a counseling/coaching style), a web-based application for participants to keep track of their physical activity, a combination of the motivational interviewing and the web-based application, and an educational program on various issues related to Parkinson's Disease. The intervention will last 6 months with a follow-up appointment at 9 months. Participants will be asked to come to Galter Pavilion at Northwestern Memorial Hospital or Shirley Ryan AbilityLab a total of five times over the course of the nine months.

Official Title
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Motivational Interviewing and Physical Activity Change in Parkinson's Disease

Conditions
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Parkinson Disease

Intervention / Treatment
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* Behavioral: Motivational Interviewing
* Behavioral: Web-based application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Community dwelling Age 18 or older Physician confirmed diagnosis of PD with Hoehn and Yahr stage ≤3 Ability to ambulate independently (walker is allowed) for distance of 50 feet or 10 minutes at a time Does not meet current CDC physical activity guidelines of 150 minutes of moderate to vigorous physical activity per week Currently and plans to have a smartphone, tablet, or computer and access to the internet for the next 9 months Willing to monitor activity on their smartphone, tablet, or computer via a web-based application during the 9-month program Currently uses the internet in a basic capacity Exclusion Criteria: Inability to speak and understand English Has a cardiovascular disorder or other health condition that would make exercise unsafe according to their physician Patients who are currently receiving physical therapy or received physical therapy one month prior to study enrollment Cognitive impairment as defined by inability to provide informed consent and to self-report feelings and behaviors Montreal Cognition Scale (MOCA): rating of less than 24, indicative of cognitive dysfunction Patients who indicate it is not recommended they participate in increased physical activity as indicated by the Physical Activity Restriction Questionnaire (PAR-Q) Patients who are in other studies that monitor fitness or physical activity

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: This study examines how a web-based application and/or motivational interviewing impact a participant's exercise routine compared to an educational control group.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Motivational Interviewing<br>Participants will talk to a coach on the phone who will employ Motivational Interviewing as a coaching style. | Behavioral: Motivational Interviewing<br>* Motivational interviewing will consist of weekly phone calls for two months, bi-weekly phone calls for two months, and monthly phone calls for two months.<br>|
| Experimental: Web-Based Application<br>Participants will use a Web-Based Application to track their daily physical activity. | Behavioral: Web-based application<br>* Web-based application participants will be asked to log activity at least on a daily basis.<br>|
| Experimental: Combination MI and App<br>Participants will have both a coach by phone who will employ Motivational Interviewing as a coaching style and use a Web-Based Application to track their daily physical activity. | Behavioral: Motivational Interviewing<br>* Motivational interviewing will consist of weekly phone calls for two months, bi-weekly phone calls for two months, and monthly phone calls for two months.<br>Behavioral: Web-based application<br>* Web-based application participants will be asked to log activity at least on a daily basis.<br>|
| No Intervention: Educational Program<br>Participants will get to use a website that contains information relevant to patients with Parkinson's Disease. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test the efficacy of the Motivational Interviewing (MI) Intervention and the Web-Based Self-Monitoring Application Intervention by monitoring the change in physical activity using data collected from an Actigraph activity monitor. | Participants will wear an Actigraph activity monitor for one week every quarter to collect data about physical activity throughout the duration of the study. Time spent doing physical activity will be compared at each assessment for this outcome. | Assessment will occur at baseline, 3 months, 6 months and 9 months. | 
| Test the efficacy of the MI Intervention and the Web-Based Self-Monitoring Application Intervention by monitoring the change in physical activity using the Physical Activity Scale for Individuals with Physical Disabilities (PASIPD). | PASIPD is a 13-item 7-day physical activity recall questionnaire designed to evaluate physical activity levels in people with physical disabilities by soliciting information about leisure time activities, household activities, and work- related activities. | Assessment will occur at baseline, 3 months, 6 months and 9 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test the efficacy of the Motivational Interviewing (MI) intervention and the Web-Based Self-Monitoring Application Intervention for improving balance using the Berg Balance Scale (BBS). | The Berg Balance Scale is a 14-item performance measure to assess static balance and fall risk. | Assessment will occur at baseline, 3 months, 6 months and 9 months. | 
| Test the efficacy of the Motivational Interviewing (MI) intervention and the Web-Based Self-Monitoring Application Intervention for improving balance using the Activities-Specific Balance Confidence Scale (ABC). | Activities-Specific Balance Confidence Scale is a 16-item self-report measure of confidence in performing various activities of daily living without falling. | Assessment will occur at baseline, 3 months, 6 months and 9 months. | 
| Test the efficacy of the Motivational Interviewing (MI) intervention and the Web-Based Self-Monitoring Application Intervention for improving balance using the Unified Parkinson's Disease Rating Scale (UPDRS). | The UPDRS is an assessment that monitors the progression of Parkinson's Disease. For this outcome, the postural stability portion of the assessment will be used to determine balance improvements. | Assessment will occur at baseline, 3 months, 6 months and 9 months. | 
| Test the efficacy of the Motivational Interviewing (MI) intervention and the Web-Based Self-Monitoring Application Intervention for improving quality of life using the assessment measure Neuro-QOL. | The Neuro-QOL is a set of self-report measures that assess the health-related quality of life of adults and children with neurological disorders. | Assessment will occur at baseline, 3 months, 6 months and 9 months. | 
| Test the efficacy of the Motivational Interviewing (MI) intervention and the Web-Based Self-Monitoring Application Intervention for improving quality of life using the assessment measure Patient-Reported Outcomes Measurement Information System (PROMIS). | PROMIS Global Health is a 10-item scale rating physical and mental health and overall quality of life. | Assessment will occur at baseline, 3 months, 6 months and 9 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's Disease, Parkinson's, Motivational Interviewing, Exercise, Motivation