Motivational Interviewing and Physical Activity Change in Parkinson's Disease

October 9, 2020 updated by: Linda Ehrlich-Jones, Shirley Ryan AbilityLab
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Shirley Ryan Abilitylab
      • Chicago, Illinois, United States, 60611
        • Northwestern Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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.
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.
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).
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.
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).
Time Frame: 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.
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).
Time Frame: 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.
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).
Time Frame: 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.
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.
Time Frame: 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.
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).
Time Frame: 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.
Assessment will occur at baseline, 3 months, 6 months and 9 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shirley Ryan AbilityLab

Collaborators

National Institute on Disability, Independent Living, and Rehabilitation Research

Investigators

  • Principal Investigator: Linda Ehrlich-Jones, PhD, Shirley Ryan Abilitylab

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2017

Primary Completion (Anticipated)

April 30, 2021

Study Completion (Anticipated)

April 30, 2021

Study Registration Dates

First Submitted

October 16, 2017

First Submitted That Met QC Criteria

October 30, 2017

First Posted (Actual)

November 6, 2017

Study Record Updates

Last Update Posted (Actual)

October 14, 2020

Last Update Submitted That Met QC Criteria

October 9, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 90IF0093

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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