Caregiver Study Dr. Phillips

Not Applicable

Completed

• Conditions: Alzheimer Disease; Dementia
• Interventions: Behavioral: Performing Arts Instruction

• Registration Number: NCT03653871
• Lead Sponsor: AdventHealth

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.

Study Timeline

• Study First Submitted: 2018-08-22
• Study First Submitted QC: 2018-08-29
• Study First Posted: 2018-08-31
• Study Start: 2018-09-11
• Primary Completion: 2019-12-30
• Study Completion: 2019-12-31
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-18
• Last Update Posted: 2020-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Performing Arts Instruction	Performing arts instruction delivered 1 hour/week for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Change caregiver burden as measured by Zarit Burden Interview	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.
Change caregiver resiliency as measured by Brief Resiliency Scale	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 Outcome Measures

Name	Time	Method
Determine if intervention helps recovery from agitation and disruptive behavior for caregivers as measured by salivary cortisol levels	Baseline to week 10	Salivary cortisol level
Determine if intervention improves caregiver's perception of care recipient's quality of life as measured by Quality of Life - Alzheimer's Disease	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.

Trial Locations

Locations (1)

Dr. Phillips Center for the Performing Arts; 🇺🇸 Orlando, Florida, United States