Caregiver Study Dr. Phillips

Sponsor
AdventHealth (Other)
Overall Status
Completed
CT.gov ID
NCT03653871
Collaborator
Dr. Phillips Center for the Performing Arts (Other)
75
1
2
15.6
4.8

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Performing Arts Instruction
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
75 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
The Effect of a Performing Arts Intervention on People With Dementia and Their Caregivers
Actual Study Start Date :
Sep 11, 2018
Actual Primary Completion Date :
Dec 30, 2019
Actual Study Completion Date :
Dec 31, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

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

Behavioral: Performing Arts Instruction
Professionally delivered performing arts curriculum

No Intervention: Wait List Control

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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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

  1. 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

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 115 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dr. Phillips Center for the Performing Arts Orlando Florida United States 32801

Sponsors and Collaborators

  • AdventHealth
  • Dr. Phillips Center for the Performing Arts

Investigators

  • Principal Investigator: Kim McManus, PhD, AdventHealth

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
AdventHealth
ClinicalTrials.gov Identifier:
NCT03653871
Other Study ID Numbers:
  • 1236971
First Posted:
Aug 31, 2018
Last Update Posted:
Feb 19, 2020
Last Verified:
Feb 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by AdventHealth
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 19, 2020