Motivational Interviewing and Physical Activity Change in Parkinson's Disease
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Shirley Ryan AbilityLab
- Enrollment
- 44
- Locations
- 2
- Primary Endpoint
- 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.
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Other
- Masking
- Double (Care Provider, Outcomes Assessor)
Masking Description
Participants will be aware which group they are assigned to. Study team members who will be providing assessments will be blinded to the condition the participant is in.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Motivational Interviewing
Participants will talk to a coach on the phone who will employ Motivational Interviewing as a coaching style.
Intervention: Motivational Interviewing (Behavioral)
Web-Based Application
Participants will use a Web-Based Application to track their daily physical activity.
Intervention: Web-based application (Behavioral)
Combination MI and App
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.
Intervention: Web-based application (Behavioral)
Combination MI and App
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.
Intervention: Motivational Interviewing (Behavioral)
Educational Program
Participants will get to use a website that contains information relevant to patients with Parkinson's Disease.
Outcomes
Primary Outcomes
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.
Time Frame: Assessment will occur at baseline, 3 months, 6 months and 9 months.
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.
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).
Time Frame: Assessment will occur at baseline, 3 months, 6 months and 9 months.
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.
Secondary Outcomes
- 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.(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 Berg Balance Scale (BBS).(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).(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).(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).(Assessment will occur at baseline, 3 months, 6 months and 9 months.)
Investigators
Linda Ehrlich-Jones
Assistant Director of Center for Rehabilitation Outcomes Research
Shirley Ryan AbilityLab