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Caregiver Study Dr. Phillips

Primary Purpose

Alzheimer Disease, Dementia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Performing Arts Instruction
Sponsored by
AdventHealth
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Alzheimer Disease focused on measuring Alzheimer Disease, Dementia, Caregiver, Performing Arts

Eligibility Criteria

18 Years - 115 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Dr. Phillips Center for the Performing Arts

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Wait List Control

Arm Description

Performing arts instruction delivered 1 hour/week for 8 weeks.

Control group. Performing arts instruction delivered upon completion of control period.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Determine if intervention helps recovery from agitation and disruptive behavior for caregivers as measured by salivary cortisol levels
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
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.

Full Information

First Posted
August 22, 2018
Last Updated
February 18, 2020
Sponsor
AdventHealth
Collaborators
Dr. Phillips Center for the Performing Arts
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1. Study Identification

Unique Protocol Identification Number
NCT03653871
Brief Title
Caregiver Study Dr. Phillips
Official Title
The Effect of a Performing Arts Intervention on People With Dementia and Their Caregivers
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
September 11, 2018 (Actual)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AdventHealth
Collaborators
Dr. Phillips Center for the Performing Arts

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Dementia
Keywords
Alzheimer Disease, Dementia, Caregiver, Performing Arts

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Performing arts instruction delivered 1 hour/week for 8 weeks.
Arm Title
Wait List Control
Arm Type
No Intervention
Arm Description
Control group. Performing arts instruction delivered upon completion of control period.
Intervention Type
Behavioral
Intervention Name(s)
Performing Arts Instruction
Intervention Description
Professionally delivered performing arts curriculum
Primary Outcome Measure Information:
Title
Change caregiver burden as measured by Zarit Burden Interview
Description
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.
Time Frame
Baseline to 22 weeks
Title
Change caregiver resiliency as measured by Brief Resiliency Scale
Description
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.
Time Frame
Baseline to 22 weeks
Secondary Outcome Measure Information:
Title
Determine if intervention helps recovery from agitation and disruptive behavior for caregivers as measured by salivary cortisol levels
Description
Salivary cortisol level
Time Frame
Baseline to week 10
Title
Determine if intervention improves caregiver's perception of care recipient's quality of life as measured by Quality of Life - Alzheimer's Disease
Description
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.
Time Frame
Baseline to 22 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
115 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim McManus, PhD
Organizational Affiliation
AdventHealth
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Phillips Center for the Performing Arts
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
World Health Organization. (2017). 10 facts on dementia. Retrieved March, 2017, from http://www.who.int/features/factfiles/dementia/en/
Results Reference
background
PubMed Identifier
27583652
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.
Results Reference
background
PubMed Identifier
18797217
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.
Results Reference
background
PubMed Identifier
17169928
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.
Results Reference
background
PubMed Identifier
21242364
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.
Results Reference
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Caregiver Study Dr. Phillips

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