Peer Partners to Improve Physical Activity in Older Latino and Latina Adults With Parkinson's Disease.

Study Overview
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Brief Summary
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The goal of this interventional study is to culturally adapt and determine feasibility of the peer partner training program and the peer-supported mobile health physical activity intervention in older Latin/Hispanic people with Parkinson's disease. The main question[s] it aims to answer are: What is the feasibility of the peer partner training program? What is the feasibility of the peer-supported mobile health physical activity intervention? What are the effects of the peer-supported mobile health physical activity intervention on physical activity, motivation, depression, apathy and self-efficacy? Participants will be asked to: Wear a research-grade activity monitor, Actigraph GT9X device for 10 days at the beginning and end of the study. Watch 11 educational videos about Parkinson´s disease and exercise and attend two virtual educational sessions. Connect with another person with Parkinson´s disease one time a week on a virtual meeting platform for 8 weeks. Use Fitbit activity monitors and connect with other participants through the Fitbit application for 8 weeks. Attend a weekly online exercise class for 8 weeks with other people with Parkinon´s disease.

Official Title
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Peer Partners to Improve Physical Activity in Older Latino and Latina Adults With Parkinson's Disease.

Conditions
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Parkinson Disease

Intervention / Treatment
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* Behavioral: Socially supported physical activity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Idiopathic Parkinson disease, Able to walk without the assistance of another person for 10 minutes -≥ 29 on Telephone Interview for Cognitive Status (TICS) To have a close friend/family member over the age of 18 that would support the participant during the intervention -≥ 50 years of age Hispanic To be willing to use an activity monitor and use a Fitbit and Fitbit application To be on a stable course of PD medications without any plans for change over the next 3 months To be able to speak, read and write in Spanish or English Exclusion Criteria: Unstable cardiopulmonary, orthopedic, psychological or metabolic condition Atypical Parkinsonism Disorders A fall in the last 6 months (that was unrelated to an external force) Currently engaging in 150 minutes of mod-vigorous physical activity/week

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This is a prospective feasibility trial, single group pre-posttest design and it aims to enroll 20 participants. For this feasibility study, the sample size is comparable to other feasibility trials in populations of individuals with Parkinson disease (Lima & Rodrigues-de-Paula, 2013; Ellis et al., 2013, Colón-Semenza et al., 2018)17,19,20. This sample size will allow for a comparison in feasibility, acceptability, and appropriateness within and across groups. This sample will allow for identifying trends and preliminary efficacy for this intervention. This study will help to inform an appropriate sample size to adequately power larger samples in future studies
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Social support for physical activity<br>Socially supported (peer, family and group) physical activity group. | Behavioral: Socially supported physical activity<br>* Use of a culturally and linguistically tailored intervention that uses mobile health technology plus social support to increase engagement in physical activity in the management of Parkinson´s disease.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of Peer Training as measured by Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM) | The investigators will examine acceptability, appropriateness, feasibility and cultural relevance through self-report surveys and qualitative interviews with study participants. The investigators will examine knowledge acquisition with a pre and post knowledge quiz. The investigators will examine training engagement with attendance at the 2 virtual training sessions. The summary score for each of the 3 surveys (AIM,IAM and FIM) will be evaluated for feasibility. Qualitative data analysis will also be completed to assess feasibility of peer training. Knowledge acquisition will be assessed by examining change score on the knowledge quiz. | After completion of peer training (2 to 3 weeks) and after completion of the intervention (8 weeks) | 
| Feasibility of Peer Support for physical activity | The investigators will examine intervention engagement, as measured by attendance at exercise classes and with the number of peer contacts acceptability, appropriateness, feasibility and cultural relevance through self-report surveys and qualitative interviews with study participants. The summary score for each of the 3 surveys (AIM,IAM and FIM) will be evaluated for feasibility. Qualitative data analysis will also be completed to assess feasibility of peer training. | After completion of peer training (2 to 3 weeks) and after completion of the intervention (8 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective measurement of physical activity | Steps per day and minutes of moderate to vigorous physical activity measured using research-grade activity monitor. The investigators will asses the group mean change in physical activity as measured by steps per day and minutes of moderate to vigorous activity from baseline to post intervention. | 10 days at baseline and post-intervention (approximately 12 to 14 weeks) | 
| Motivation of physical activity measurement | Assessment of motivations through the Behavioral Regulation in Exercise Questionnaire. It is a 19-item survey that evaluates the stages of motivation to exercise. This includes amotivation, external regulation, introjected regulation, identified regulation, and intrinsic regulation. The investigators will evaluate the group mean change of sub-scores as well as total scores related to motivation. | Baseline and post Intervention (approximately 12 to 14 weeks) | 
| Quality of Life Measurement | Quality of Life measured by the Parkinson Disease Questionnaire-39 (PDQ-39). This is 39-item self-report survey that assess quality of life. This covers an assessment of mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort.The investigators will evaluate the group mean change of sub-scores as well as total scores related to quality of life. | Pre and post intervention (approximately 12 to 14 weeks) | 
| Depression and Apathy Screening | Screening for Depression and Apathy in older adults using the Geriatric Depression Scale (GDS), a 15-item self-report measure of depression in older adults, and Lille Apathy Rating Scale (LARS) which is a 33-item structured interview designed to assess apathy in Parkinson's disease. The investigators will evaluate the group mean change of sub-scores as well as total scores related to depression and apathy. | Pre and post intervention (approximately 12 to 14 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Peer Support, Hispanic, Parkinson´s Disease