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Caregiver Study Dr. Phillips

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03653871
Enrollment
75
Registered
2018-08-31
Start date
2018-09-11
Completion date
2019-12-31
Last updated
2020-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease, Dementia

Keywords

Alzheimer Disease, Dementia, Caregiver, Performing Arts

Brief summary

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

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.

Interventions

BEHAVIORALPerforming Arts Instruction

Professionally delivered performing arts curriculum

Sponsors

Dr. Phillips Center for the Performing Arts
CollaboratorUNKNOWN
AdventHealth
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 115 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change caregiver burden as measured by Zarit Burden InterviewBaseline to 22 weeksZarit 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.
Change caregiver resiliency as measured by Brief Resiliency ScaleBaseline to 22 weeksBrief 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

MeasureTime frameDescription
Determine if intervention helps recovery from agitation and disruptive behavior for caregivers as measured by salivary cortisol levelsBaseline to week 10Salivary cortisol level
Determine if intervention improves caregiver's perception of care recipient's quality of life as measured by Quality of Life - Alzheimer's DiseaseBaseline to 22 weeksQuality 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026