Motivational Interviewing and Physical Activity Change in Parkinson's Disease

NCT03329833 | Unknown

• 1 other identifier: 90IF0093
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

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.

Conditions

Parkinson Disease

Keywords

Parkinson's Disease; Parkinson's; Motivational Interviewing; Exercise; Motivation

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  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 Outcomes (5)

• 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 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 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.

Study Arms (4)

Motivational Interviewing

EXPERIMENTAL

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

Behavioral: Motivational Interviewing

Web-Based Application

EXPERIMENTAL

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

Behavioral: Web-based application

Combination MI and App

EXPERIMENTAL

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; Behavioral: Web-based application

Educational Program

NO INTERVENTION

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

Interventions

Motivational Interviewing BEHAVIORAL

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.

Combination MI and App; Motivational Interviewing

Web-based application BEHAVIORAL

Web-based application participants will be asked to log activity at least on a daily basis.

Combination MI and App; Web-Based Application

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead
• National Institute on Disability, Independent Living, and Rehabilitation Research: collaborator

Study Sites (2)

Northwestern Medicine

Chicago, Illinois, 60611, United States

Location

Shirley Ryan Abilitylab

Chicago, Illinois, 60611, United States

Location

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MeSH Terms

Conditions

Parkinson Disease; Motor Activity

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavior

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Linda Ehrlich-Jones, PhD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Director of Center for Rehabilitation Outcomes Research

Model Details: This study examines how a web-based application and/or motivational interviewing impact a participant's exercise routine compared to an educational control group.

Study Record Dates

• First Submitted: October 16, 2017
• First Posted: November 6, 2017
• Study Start: November 20, 2017
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: October 14, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)