Caregiver Study Dr. Phillips

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03653871
• Other study ID #: 1236971
• Status: Completed
• Phase: N/A
• Start date: September 11, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2020
• Source: Florida Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 31, 2019
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 115 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia

Intervention

Behavioral:
• Performing Arts Instruction
Professionally delivered performing arts curriculum

Locations

Country	Name	City	State
United States	Dr. Phillips Center for the Performing Arts	Orlando	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Florida Hospital	Dr. Phillips Center for the Performing Arts

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. Erratum in: Ann Intern Med. 2011 May 17;154(10):708. — View 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. Review. — View Citation

Wimo A, Guerchet M, Ali GC, Wu YT, Prina AM, Winblad B, Jönsson 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. — View Citation

World Health Organization. (2017). 10 facts on dementia. Retrieved March, 2017, from http://www.who.int/features/factfiles/dementia/en/

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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