Back to resultsPiano Training, Caregivers, and Parkinson's Disease
Primary Purpose
Depression, Mood, Burden, Dependency
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group piano training
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring caregiver, Parkinson's disease, group piano training
Eligibility 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
Sites / Locations
- University of Miami
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Piano group
Arm Description
This group will consist of the adult with Parkinson's disease and their caregiver for a total of 14 pairs.
Outcomes
Primary Outcome Measures
Change in caregiver burden as assessed by the Zarit Burden Interview.
The Zarit burden is a 22-item questionnaire with range from 0-88 with a higher score indicating severe burden.
Secondary Outcome Measures
Change in depression as assessed by the Center for Epidemiological Studies for Depression (CES-D).
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).
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).
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03922672
Brief Title
Piano Training, Caregivers, and Parkinson's Disease
Official Title
The Impact of Group Piano Training on Psychosocial Outcomes in Caregivers of Adults With Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Terminated
Why Stopped
COVID-19 pandemic
Study Start Date
August 22, 2019 (Actual)
Primary Completion Date
August 15, 2020 (Actual)
Study Completion Date
August 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Mood, Burden, Dependency
Keywords
caregiver, Parkinson's disease, group piano training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Piano group
Arm Type
Experimental
Arm Description
This group will consist of the adult with Parkinson's disease and their caregiver for a total of 14 pairs.
Intervention Type
Behavioral
Intervention Name(s)
Group piano training
Intervention Description
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 Measure Information:
Title
Change in caregiver burden as assessed by the Zarit Burden Interview.
Description
The Zarit burden is a 22-item questionnaire with range from 0-88 with a higher score indicating severe burden.
Time Frame
Baseline to month 1, baseline to month 2, baseline to month 4
Secondary Outcome Measure Information:
Title
Change in depression as assessed by the Center for Epidemiological Studies for Depression (CES-D).
Description
The CES-D is a 20-item questionnaire with range from 0-60 with a higher score indicating increased symptoms of depression.
Time Frame
Baseline to month 1, baseline to month 2, baseline to month 4
Title
Change in musical self-efficacy as assessed by the Musical Performance Self-Efficacy Scale (MPSE).
Description
The MPSE is a 24 item questionnaire with range from 0-2400 with a higher score indicating improved musical self-efficacy.
Time Frame
Baseline to month 1, baseline to month 2, baseline to month 4
Title
Change in mood by the Profile of Mood States - Brief Form (POMS-BF).
Description
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.
Time Frame
From month 1 to month 4.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teresa L Lesiuk, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Piano Training, Caregivers, and Parkinson's Disease
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