Clinical trial NCT03653871: Caregiver Study Dr. Phillips
Official title: The Effect of a Performing Arts Intervention on People With Dementia and Their Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Dementia
Keywords: Alzheimer Disease
Dementia
Caregiver
Performing Arts
Lead sponsor: AdventHealth
Sponsor class: OTHER
Collaborators: name: Dr. Phillips Center for the Performing Arts
First posted: 2018-08-31
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 115
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change caregiver burden as measured by Zarit Burden Interview
timeFrame: Baseline to 22 weeks
measure: Change caregiver resiliency as measured by Brief Resiliency Scale
timeFrame: Baseline to 22 weeks
Secondary outcomes:
measure: Determine if intervention helps recovery from agitation and disruptive behavior for caregivers as measured by salivary cortisol levels
timeFrame: Baseline to week 10
measure: Determine if intervention improves caregiver's perception of care recipient's quality of life as measured by Quality of Life - Alzheimer's Disease
timeFrame: Baseline to 22 weeks
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Dr. Phillips Center for the Performing Arts
state: Florida
Study officials:
affiliation: AdventHealth
name: Kim McManus, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: World Health Organization. (2017). 10 facts on dementia. Retrieved March, 2017, from http://www.who.int/features/factfiles/dementia/en/
citation: Wimo A, Guerchet M, Ali GC, Wu YT, Prina AM, Winblad B, Jonsson L, Liu Z, Prince M. The worldwide costs of dementia 2015 and comparisons with 2010. Alzheimers Dement. 2017 Jan;13(1):1-7. doi: 10.1016/j.jalz.2016.07.150. Epub 2016 Aug 29.
citation: Schulz R, Sherwood PR. Physical and mental health effects of family caregiving. Am J Nurs. 2008 Sep;108(9 Suppl):23-7; quiz 27. doi: 10.1097/01.NAJ.0000336406.45248.4c.
citation: Cohen GD, Perlstein S, Chapline J, Kelly J, Firth KM, Simmens S. The impact of professionally conducted cultural programs on the physical health, mental health, and social functioning of older adults. Gerontologist. 2006 Dec;46(6):726-34. doi: 10.1093/geront/46.6.726.
citation: Houston TK, Allison JJ, Sussman M, Horn W, Holt CL, Trobaugh J, Salas M, Pisu M, Cuffee YL, Larkin D, Person SD, Barton B, Kiefe CI, Hullett S. Culturally appropriate storytelling to improve blood pressure: a randomized trial. Ann Intern Med. 2011 Jan 18;154(2):77-84. doi: 10.7326/0003-4819-154-2-201101180-00004.