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出境医 / 临床实验 / Piano Training, Caregivers, and Parkinson's Disease

Piano Training, Caregivers, and Parkinson's Disease

Study Description
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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: N/A
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
Arms and Interventions
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.
Outcome Measures
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.


Eligibility Criteria
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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
Contacts and Locations

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
Tracking Information
First Submitted Date  ICMJE April 17, 2019
First Posted Date  ICMJE April 22, 2019
Last Update Posted Date August 27, 2020
Actual Study Start Date  ICMJE August 22, 2019
Estimated Primary Completion Date October 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2019) 		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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2019)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Piano Training, Caregivers, and Parkinson's Disease
Official Title  ICMJE The Impact of Group Piano Training on Psychosocial Outcomes in Caregivers of Adults With Parkinson's Disease
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Depression
  • Mood
  • Burden, Dependency
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Piano group
This group will consist of the adult with Parkinson's disease and their caregiver for a total of 14 pairs.
Intervention: Behavioral: Group piano training
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 17, 2019) 		28
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 1, 2021
Estimated Primary Completion Date October 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Teresa L Lesiuk, PhD 305-284-3650 tlesiuk@miami.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03922672
Other Study ID Numbers  ICMJE 20180888
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Teresa Lesiuk, University of Miami
Study Sponsor  ICMJE University of Miami
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Teresa L Lesiuk, PhD University of Miami
PRS Account University of Miami
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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