Motivational Interviewing and Physical Activity Change in Parkinson's Disease

Sponsor

Shirley Ryan AbilityLab (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03329833

Collaborator

National Institute on Disability, Independent Living, and Rehabilitation Research (U.S. Fed)

Enrollment

Locations

Arms

41.3

Anticipated Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease	Behavioral: Motivational Interviewing Behavioral: Web-based application	N/A

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

Actual Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Intervention 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.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 (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.

Primary Purpose:

Other

Official Title:

Motivational Interviewing and Physical Activity Change in Parkinson's Disease

Actual Study Start Date :

Nov 20, 2017

Anticipated Primary Completion Date :

Apr 30, 2021

Anticipated Study Completion Date :

Apr 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Motivational Interviewing Participants will talk to a coach on the phone who will employ Motivational Interviewing as a coaching style.	Behavioral: Motivational Interviewing 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.
Experimental: Web-Based Application Participants will use a Web-Based Application to track their daily physical activity.	Behavioral: Web-based application Web-based application participants will be asked to log activity at least on a daily basis.
Experimental: 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.	Behavioral: Motivational Interviewing 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. Behavioral: Web-based application Web-based application participants will be asked to log activity at least on a daily basis.
No Intervention: Educational Program Participants will get to use a website that contains information relevant to patients with Parkinson's Disease.

Outcome Measures

Primary Outcome Measures

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. [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). [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 Outcome Measures

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.]
The Berg Balance Scale is a 14-item performance measure to assess static balance and fall risk.
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.]
Activities-Specific Balance Confidence Scale is a 16-item self-report measure of confidence in performing various activities of daily living without falling.
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.]
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.
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.]
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.
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.]
PROMIS Global Health is a 10-item scale rating physical and mental health and overall quality of life.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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