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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06170866
• Other study ID #: 23-117S-2
• Secondary ID: P30AG067988
• Status: Recruiting
• Phase: N/A
• Start date: November 16, 2023
• Est. completion date: July 2024

Study information

• Verified date: December 2023
• Source: UConn Health
• Contact: Cristina Colón-Semenza, PhD
• Phone: 8604860019
• Email: cristina.colon-semenza[@]uconn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Behavioral:
• Socially supported physical activity
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.

Locations

Country	Name	City	State
United States	University of Connecticut	Storrs	Connecticut

Sponsors (3)

Lead Sponsor	Collaborator
UConn Health	National Institute on Aging (NIA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

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* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)