Motivational Interviewing and Physical Activity Change in Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Motivational Interviewing and Physical Activity Change in Parkinson's Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03329833
• Other study ID #: 90IF0093
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 20, 2017
• Est. completion date: April 30, 2021

Study information

• Verified date: October 2020
• Source: Shirley Ryan AbilityLab
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 44
• Est. completion date: April 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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

Locations

Country	Name	City	State
United States	Northwestern Medicine	Chicago	Illinois
United States	Shirley Ryan Abilitylab	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Shirley Ryan AbilityLab	National Institute on Disability, Independent Living, and Rehabilitation Research

Country where clinical trial is conducted

United States, 

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* Note: There are 48 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.	Assessment will occur at baseline, 3 months, 6 months and 9 months.
Secondary	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.	Assessment will occur at baseline, 3 months, 6 months and 9 months.
Secondary	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.	Assessment will occur at baseline, 3 months, 6 months and 9 months.
Secondary	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.	Assessment will occur at baseline, 3 months, 6 months and 9 months.
Secondary	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.	Assessment will occur at baseline, 3 months, 6 months and 9 months.