Caregiver Study Dr. Phillips

February 18, 2020 updated by: AdventHealth

The Effect of a Performing Arts Intervention on People With Dementia and Their Caregivers

This study will examine whether a performing arts class will improve the well-being of primary unpaid caregivers of people with dementia

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study used sample size analysis to determine the adequately sized intervention group and control group, well-defined statistical methodology, and a well-documented intervention that can be easily replicated. The intervention has been developed by Dr. Phillips Center for the Performing Arts leadership with assistance from AMS Planning & Research.

Study Type

Interventional

Enrollment (Actual)

75

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

  • United States
    • Florida
      • Orlando, Florida, United States, 32801
        • Dr. Phillips Center for the Performing Arts

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

18 years to 115 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Primary, unpaid caregiver of person with dementia OR
  • Person with Dementia.
  • Live independently in the community.
  • Care recipient has a Functional Assessment Staging Test (FAST) Score of 4-6b.
  • Caregiver does not display symptoms of emotional, cognitive, or mental impairment.
  • Caregiver must be able to produce adequate saliva sample.
  • Caregiver/care recipient can travel to program.
  • Caregiver/care recipient agree to participate in all aspects of study intervention and assessments.
  • Caregiver is 18 years of age or older.
  • Care recipient is 65 years of age or older
  • Access to home phone or mobile phone

Exclusion Criteria:

  • Unable to understand either spoken and/or written English.
  • Caregiver is a paid employee of care recipient's legally appointed representative

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Performing arts instruction delivered 1 hour/week for 8 weeks.
Behavioral: Performing Arts Instruction
Professionally delivered performing arts curriculum
No Intervention: Wait List Control
Control group. Performing arts instruction delivered upon completion of control period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change caregiver burden as measured by Zarit Burden Interview
Time Frame: Baseline to 22 weeks
Zarit Burden Interview is a caregiver self-report measure. The Interview uses a 5 point Likert Scale (Never - 0, Rarely - 1, Sometimes - 2, Quite Frequently - 3, Nearly Always - 4). Score can range from 0- to 88. 0-21 - little or no burden, 21-40 mild to moderate burden, 41-60 moderate to severe burden, 61-88 severe burden. A lower score represents a better outcome.
Baseline to 22 weeks
Change caregiver resiliency as measured by Brief Resiliency Scale
Time Frame: Baseline to 22 weeks
Brief Resilience Scale is a self report of items using a 5 point Likert Scale. Three of the items, the scale is as follows: (Strongly Disagree-1, Strongly Agree -5) For the remaining 3 items, the scale is reversed (Strongly Agree - 5, Strongly Agree 1) Score can range from 6-30 and is divided by 6. A higher score represents a better outcome.
Baseline to 22 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine if intervention helps recovery from agitation and disruptive behavior for caregivers as measured by salivary cortisol levels
Time Frame: Baseline to week 10
Salivary cortisol level
Baseline to week 10
Determine if intervention improves caregiver's perception of care recipient's quality of life as measured by Quality of Life - Alzheimer's Disease
Time Frame: Baseline to 22 weeks
Quality of Life - Alzheimer's Disease is a self-report of items using a 4 point Likert Scale (Poor - 1, Fair - 2, Good - 3, Excellent - 4) The score ranges from 13-52. A higher score represents a better outcome.
Baseline to 22 weeks

Collaborators and Investigators

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

Sponsor

AdventHealth

Collaborators

Dr. Phillips Center for the Performing Arts

Investigators

  • Principal Investigator: Kim McManus, PhD, AdventHealth

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

September 11, 2018

Primary Completion (Actual)

December 30, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

August 22, 2018

First Submitted That Met QC Criteria

August 29, 2018

First Posted (Actual)

August 31, 2018

Study Record Updates

Last Update Posted (Actual)

February 19, 2020

Last Update Submitted That Met QC Criteria

February 18, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1236971

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

product manufactured in and exported from the U.S.

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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