Skip to main content
OpenTrials
Completed

NCT Number: NCT03653871

Caregiver Study Dr. Phillips

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year–115 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Phillips Center for the Performing Arts

Orlando, Florida, 32801, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Performing Arts Instruction

Behavioral

Professionally delivered performing arts curriculum

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

AdventHealth

Other

Collaborators

  • Dr. Phillips Center for the Performing Arts

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 31, 2018
Registry last updated
Feb 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.