NCT03922672

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Aug 2019

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 22, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

August 22, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2020

Completed
Last Updated

August 19, 2021

Status Verified

August 1, 2021

Enrollment Period

12 months

First QC Date

April 17, 2019

Last Update Submit

August 13, 2021

Conditions

Keywords

caregiverParkinson's diseasegroup piano training

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline to month 1, baseline to month 2, baseline to month 4

Secondary Outcomes (3)

  • Change in depression as assessed by the Center for Epidemiological Studies for Depression (CES-D).

    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).

    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).

    From month 1 to month 4.

Study Arms (1)

Piano group

EXPERIMENTAL

This group will consist of the adult with Parkinson's disease and their caregiver for a total of 14 pairs.

Behavioral: Group piano training

Interventions

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.

Piano group

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Miami, Florida, 33146, United States

Location

MeSH Terms

Conditions

DepressionParkinson Disease

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorParkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Teresa L Lesiuk, PhD

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 17, 2019

First Posted

April 22, 2019

Study Start

August 22, 2019

Primary Completion

August 15, 2020

Study Completion

August 15, 2020

Last Updated

August 19, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations