Piano Training, Caregivers, and Parkinson's Disease

August 13, 2021 updated by: Teresa Lesiuk, University of Miami

The Impact of Group Piano Training on Psychosocial Outcomes in Caregivers of Adults With Parkinson's Disease

The purpose of this study is to investigate the impact of group piano training on psychosocial outcomes in caregivers of adults with Parkinson's disease (PD). As well, the study is investigating the impact of group piano training on psychosocial outcomes in the care-recipient with PD.

Study Overview

Status

Terminated

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Florida
      • Miami, Florida, United States, 33146
        • University of Miami

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Caregiver:

    • Are currently a primary caregiver to an adult with PD
    • Are between the age of 40-80 years
    • Have less than 5 years of music training
    • Speak and read English fluently

Adult with PD:

  • Stage 1-3 Parkinson's disease
  • Are between the age of 40-80
  • Have less than 5 years of music training
  • Speak and read English fluently

Exclusion Criteria:

  • Doesn't meet all the inclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Piano group
This group will consist of the adult with Parkinson's disease and their caregiver for a total of 14 pairs.
The group piano training is scheduled over 4 months of a two-hour weekly group piano lesson. There is also a 3-hour weekly practice at home.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in caregiver burden as assessed by the Zarit Burden Interview.
Time Frame: Baseline to month 1, baseline to month 2, baseline to month 4
The Zarit burden is a 22-item questionnaire with range from 0-88 with a higher score indicating severe burden.
Baseline to month 1, baseline to month 2, baseline to month 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in depression as assessed by the Center for Epidemiological Studies for Depression (CES-D).
Time Frame: Baseline to month 1, baseline to month 2, baseline to month 4
The CES-D is a 20-item questionnaire with range from 0-60 with a higher score indicating increased symptoms of depression.
Baseline to month 1, baseline to month 2, baseline to month 4
Change in musical self-efficacy as assessed by the Musical Performance Self-Efficacy Scale (MPSE).
Time Frame: Baseline to month 1, baseline to month 2, baseline to month 4
The MPSE is a 24 item questionnaire with range from 0-2400 with a higher score indicating improved musical self-efficacy.
Baseline to month 1, baseline to month 2, baseline to month 4
Change in mood by the Profile of Mood States - Brief Form (POMS-BF).
Time Frame: From month 1 to month 4.
The POMS-BF is a 30 item questionnaire with six sub-scale scored on a 5-point Likert scale with a higher total score indicating increased negative mood.
From month 1 to month 4.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Teresa L Lesiuk, PhD, University of Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 22, 2019

Primary Completion (ACTUAL)

August 15, 2020

Study Completion (ACTUAL)

August 15, 2020

Study Registration Dates

First Submitted

April 17, 2019

First Submitted That Met QC Criteria

April 17, 2019

First Posted (ACTUAL)

April 22, 2019

Study Record Updates

Last Update Posted (ACTUAL)

August 19, 2021

Last Update Submitted That Met QC Criteria

August 13, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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