Caregiver Study Dr. Phillips
The Effect of a Performing Arts Intervention on People With Dementia and Their Caregivers
1 other identifier
interventional
75
1 country
1
Brief Summary
This study will examine whether a performing arts class will improve the well-being of primary unpaid caregivers of people with dementia
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable alzheimer-disease
Started Sep 2018
Shorter than P25 for not_applicable alzheimer-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 22, 2018
CompletedFirst Posted
Study publicly available on registry
August 31, 2018
CompletedStudy Start
First participant enrolled
September 11, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedFebruary 19, 2020
February 1, 2020
1.3 years
August 22, 2018
February 18, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Determine if intervention helps recovery from agitation and disruptive behavior for caregivers as measured by salivary cortisol levels
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
Baseline to 22 weeks
Study Arms (2)
Intervention
EXPERIMENTALPerforming arts instruction delivered 1 hour/week for 8 weeks.
Wait List Control
NO INTERVENTIONControl group. Performing arts instruction delivered upon completion of control period.
Interventions
Professionally delivered performing arts curriculum
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Unable to understand either spoken and/or written English.
- Caregiver is a paid employee of care recipient's legally appointed representative
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AdventHealthlead
- Dr. Phillips Center for the Performing Artscollaborator
Study Sites (1)
Dr. Phillips Center for the Performing Arts
Orlando, Florida, 32801, United States
Related Publications (5)
World Health Organization. (2017). 10 facts on dementia. Retrieved March, 2017, from http://www.who.int/features/factfiles/dementia/en/
BACKGROUNDWimo 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.
PMID: 27583652BACKGROUNDSchulz 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.
PMID: 18797217BACKGROUNDCohen 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.
PMID: 17169928BACKGROUNDHouston 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.
PMID: 21242364BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kim McManus, PhD
AdventHealth
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2018
First Posted
August 31, 2018
Study Start
September 11, 2018
Primary Completion
December 30, 2019
Study Completion
December 31, 2019
Last Updated
February 19, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share