Caregiver Study Dr. Phillips

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

Detailed Description
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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.

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

Conditions
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Alzheimer Disease, Dementia

Intervention / Treatment
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* Behavioral: Performing Arts Instruction


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 115 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change caregiver burden as measured by Zarit Burden Interview | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alzheimer Disease, Dementia, Caregiver, Performing Arts