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Motivational Interviewing and Physical Activity Change in Parkinson's Disease

Primary Purpose

Parkinson Disease

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivational Interviewing
Web-based application
Sponsored by
Shirley Ryan AbilityLab
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Parkinson Disease focused on measuring Parkinson's Disease, Parkinson's, Motivational Interviewing, Exercise, Motivation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Northwestern Medicine
  • Shirley Ryan Abilitylab

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Motivational Interviewing

Web-Based Application

Combination MI and App

Educational Program

Arm Description

Participants will talk to a coach on the phone who will employ Motivational Interviewing as a coaching style.

Participants will use a Web-Based Application to track their daily physical activity.

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.

Participants will get to use a website that contains information relevant to patients with Parkinson's Disease.

Outcomes

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.
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).
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).
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).
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).
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.
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).
PROMIS Global Health is a 10-item scale rating physical and mental health and overall quality of life.

Full Information

First Posted
October 16, 2017
Last Updated
October 9, 2020
Sponsor
Shirley Ryan AbilityLab
Collaborators
National Institute on Disability, Independent Living, and Rehabilitation Research
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1. Study Identification

Unique Protocol Identification Number
NCT03329833
Brief Title
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

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 20, 2017 (Actual)
Primary Completion Date
April 30, 2021 (Anticipated)
Study Completion Date
April 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shirley Ryan AbilityLab
Collaborators
National Institute on Disability, Independent Living, and Rehabilitation Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson's Disease, Parkinson's, Motivational Interviewing, Exercise, Motivation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
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
Care ProviderOutcomes 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.
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Motivational Interviewing
Arm Type
Experimental
Arm Description
Participants will talk to a coach on the phone who will employ Motivational Interviewing as a coaching style.
Arm Title
Web-Based Application
Arm Type
Experimental
Arm Description
Participants will use a Web-Based Application to track their daily physical activity.
Arm Title
Combination MI and App
Arm Type
Experimental
Arm Description
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.
Arm Title
Educational Program
Arm Type
No Intervention
Arm Description
Participants will get to use a website that contains information relevant to patients with Parkinson's Disease.
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Web-based application
Intervention Description
Web-based application participants will be asked to log activity at least on a daily basis.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
Assessment will occur at baseline, 3 months, 6 months and 9 months.
Title
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).
Description
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.
Time Frame
Assessment will occur at baseline, 3 months, 6 months and 9 months.
Secondary Outcome Measure Information:
Title
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).
Description
The Berg Balance Scale is a 14-item performance measure to assess static balance and fall risk.
Time Frame
Assessment will occur at baseline, 3 months, 6 months and 9 months.
Title
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).
Description
Activities-Specific Balance Confidence Scale is a 16-item self-report measure of confidence in performing various activities of daily living without falling.
Time Frame
Assessment will occur at baseline, 3 months, 6 months and 9 months.
Title
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).
Description
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.
Time Frame
Assessment will occur at baseline, 3 months, 6 months and 9 months.
Title
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.
Description
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.
Time Frame
Assessment will occur at baseline, 3 months, 6 months and 9 months.
Title
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).
Description
PROMIS Global Health is a 10-item scale rating physical and mental health and overall quality of life.
Time Frame
Assessment will occur at baseline, 3 months, 6 months and 9 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda Ehrlich-Jones, PhD
Organizational Affiliation
Shirley Ryan AbilityLab
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Shirley Ryan Abilitylab
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Goetz CG, Tilley BC, Shaftman SR, Stebbins GT, Fahn S, Martinez-Martin P, Poewe W, Sampaio C, Stern MB, Dodel R, Dubois B, Holloway R, Jankovic J, Kulisevsky J, Lang AE, Lees A, Leurgans S, LeWitt PA, Nyenhuis D, Olanow CW, Rascol O, Schrag A, Teresi JA, van Hilten JJ, LaPelle N; Movement Disorder Society UPDRS Revision Task Force. Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): scale presentation and clinimetric testing results. Mov Disord. 2008 Nov 15;23(15):2129-70. doi: 10.1002/mds.22340.
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Motivational Interviewing and Physical Activity Change in Parkinson's Disease

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