Alzheimer DiseaseNCT03653871
Caregiver Study Dr. Phillips
A study testing Performing Arts Instruction in people with Alzheimer Disease and Dementia, run by AdventHealth at 1 site in United States.
Trial summary
This study will examine whether a performing arts class will improve the well-being of primary unpaid caregivers of people with dementia Read more about this study
- Who is it for?
- Ages 18 to 115 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Dementia
- What is being tested?
- Performing Arts Instruction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 115 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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
Who cannot join
- Unable to understand either spoken and/or written English.
- Caregiver is a paid employee of care recipient's legally appointed representative
Trial locations and contacts
1 site in 1 country.
United States1 site
Dr. Phillips Center for the Performing Arts
Orlando, Florida, 32801
About this study
Official title: The Effect of a Performing Arts Intervention on People With Dementia and Their Caregivers
This study will examine whether a performing arts class will improve the well-being of primary unpaid caregivers of people with dementia
Read the 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.
- Conditions
- Alzheimer Disease, Dementia
- Being tested
- Performing Arts Instruction
- Keywords
- Alzheimer Disease, Dementia, Caregiver, Performing Arts
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Performing Arts InstructionBehavioural
Professionally delivered performing arts curriculum
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Performing arts instruction delivered 1 hour/week for 8 weeks. Receives: Behavioral: Performing Arts Instruction |
| Wait List Control | No intervention | Control group. Performing arts instruction delivered upon completion of control period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Salivary cortisol level
Measured: 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
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.
Measured: Baseline to 22 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start11 Sep 2018
- Primary completion30 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- AdventHealth
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Phillips Center for the Performing Arts
- Responsible party
- Sponsor
- Investigators
- Kim McManus, PhD, Principal investigator, AdventHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03653871
- Sponsor's protocol ID
- 1236971
- Status last verified
- Feb 2020
- First submitted
- 22 Aug 2018
- Last updated
- 19 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
World Health Organization. (2017). 10 facts on dementia. Retrieved March, 2017, from http://www.who.int/features/factfiles/dementia/en/
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.
PubMed 27583652Schulz 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.
PubMed 18797217Cohen 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.
PubMed 17169928Houston 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.
PubMed 21242364
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Performing Arts Intervention on People With Dementia and Their Caregivers
- ClinicalTrials.gov ID
- NCT03653871
- Acronym / sponsor ID
- 1236971
- Conditions
- Alzheimer Disease, Dementia
- Keywords
- Alzheimer Disease, Dementia, Caregiver, Performing Arts
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- AdventHealthUniversity, hospital or other
- Collaborators
- Dr. Phillips Center for the Performing Arts
- Study start
- 11 Sep 2018 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 31 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Performing Arts InstructionPerforming arts instruction delivered 1 hour/week for 8 weeks. |
| Wait List Control | No intervention | –Control group. Performing arts instruction delivered upon completion of control period. |
Who may qualify
- Ages
- 18 to 115 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (2 listed)
- Unable to understand either spoken and/or written English.
- Caregiver is a paid employee of care recipient's legally appointed representative
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Performing Arts InstructionProfessionally delivered performing arts curriculum | Behavioural | Intervention |
Primary outcome
Change caregiver burden as measured by Zarit Burden Interview
Time frame: 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.
Change caregiver resiliency as measured by Brief Resiliency Scale
Time frame: 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.
2 secondary outcomes
Determine if intervention helps recovery from agitation and disruptive behavior for caregivers as measured by salivary cortisol levels
Time frame: 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
Time frame: Baseline to 22 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2020.
- BackgroundWorld Health Organization. (2017). 10 facts on dementia. Retrieved March, 2017, from http://www.who.int/features/factfiles/dementia/en/
- Background: PubMed 27583652Wimo 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.
- Background: PubMed 18797217Schulz 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.
- Background: PubMed 17169928Cohen 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.
- Background: PubMed 21242364Houston 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kim McManus, PhD principal investigator
AdventHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Performing Arts Instruction in people with Alzheimer Disease and Dementia, run by AdventHealth at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change caregiver burden as measured by Zarit Burden Interview (time frame: Baseline to 22 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03653871, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2020.