Clinical trial NCT03329833: Motivational Interviewing and Physical Activity Change in Parkinson's Disease
Official title: Motivational Interviewing and Physical Activity Change in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson's Disease
Parkinson's
Motivational Interviewing
Exercise
Motivation
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
Collaborators: name: National Institute on Disability, Independent Living, and Rehabilitation Research
First posted: 2017-11-06
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
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.
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: Assessment will occur at baseline, 3 months, 6 months and 9 months.
measure: 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).
timeFrame: Assessment will occur at baseline, 3 months, 6 months and 9 months.
Secondary outcomes:
measure: 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).
timeFrame: Assessment will occur at baseline, 3 months, 6 months and 9 months.
measure: 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).
timeFrame: Assessment will occur at baseline, 3 months, 6 months and 9 months.
measure: 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).
timeFrame: Assessment will occur at baseline, 3 months, 6 months and 9 months.
measure: 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.
timeFrame: Assessment will occur at baseline, 3 months, 6 months and 9 months.
measure: 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).
timeFrame: Assessment will occur at baseline, 3 months, 6 months and 9 months.
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Medicine
state: Illinois
city: Chicago
country: United States
facility: Shirley Ryan Abilitylab
state: Illinois
Study officials:
affiliation: Shirley Ryan AbilityLab
name: Linda Ehrlich-Jones, PhD
role: PRINCIPAL_INVESTIGATOR
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