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Piano Training, Caregivers, and Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT03922672
Recruitment Status : Recruiting
First Posted : April 22, 2019
Last Update Posted : September 6, 2019
Sponsor:
Information provided by (Responsible Party):
Teresa Lesiuk, University of Miami

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Depression Mood Burden, Dependency Behavioral: Group piano training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Impact of Group Piano Training on Psychosocial Outcomes in Caregivers of Adults With Parkinson's Disease
Actual Study Start Date : August 22, 2019
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine


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.
Behavioral: Group piano training
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03922672


Contacts
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Contact: Teresa L Lesiuk, PhD 305-284-3650 tlesiuk@miami.edu

Locations
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United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33146
Contact: Teresa L Lesiuk, PhD    305-284-3650    tlesiuk@miami.edu   
Principal Investigator: Teresa L Lesiuk, PhD         
Sponsors and Collaborators
University of Miami
Investigators
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Principal Investigator: Teresa L Lesiuk, PhD University of Miami

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Responsible Party: Teresa Lesiuk, Associate Professor, University of Miami
ClinicalTrials.gov Identifier: NCT03922672     History of Changes
Other Study ID Numbers: 20180888
First Posted: April 22, 2019    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Teresa Lesiuk, University of Miami:
caregiver
Parkinson's disease
group piano training
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases