Caregiver Study Dr. Phillips

NCT ID: NCT03653871

Last Updated: 2020-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-11

Study Completion Date

2019-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Alzheimer Disease Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention

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

Group Type EXPERIMENTAL

Performing Arts Instruction

Intervention Type BEHAVIORAL

Professionally delivered performing arts curriculum

Wait List Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Performing Arts Instruction

Professionally delivered performing arts curriculum

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

115 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dr. Phillips Center for the Performing Arts

UNKNOWN

Sponsor Role collaborator

AdventHealth

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kim McManus, PhD

Role: PRINCIPAL_INVESTIGATOR

AdventHealth

Locations

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Dr. Phillips Center for the Performing Arts

Orlando, Florida, United States

Site Status

Countries

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United States

References

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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 27583652 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18797217 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17169928 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21242364 (View on PubMed)

Other Identifiers

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1236971

Identifier Type: -

Identifier Source: org_study_id

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