- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04350060
Improving the Quality of Dementia Care Through Innovative Redesign of the Memory Care Environment
August 25, 2025 updated by: Ying Ying (Christina) Chen, Mayo Clinic
Memory Care of the Future: Improving the Quality of Dementia Care Through Innovative Redesign of the Memory Care Environment
Research study is being done to demonstrate novel opportunities to transform the way the dementia community is cared for.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 100 years (Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients currently residing at Arbor Terrace memory care unit
- Patients diagnosed with dementia
Exclusion Criteria:
- Hospice patients with less than 30 days of life expectancy at the time of enrollment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Standard of Care Group
|
|
|
Experimental: Intervention Group
Subjects with dementia will be living in a retro-fitted room with technological enhancements for a 12 month period.
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Reconstructing and retrofitting a currently existing memory care room at Samaritan Bethany Arbor Terrace Senior Living with integrated technologies specifically to accommodate the needs of persons with dementia to enhance sensory stimulation in sight, sound and sleep.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in quality of life, as measured by the Quality of Life in Alzheimer's disease (QOL-AD)
Time Frame: every 2 weeks for up to one year
|
Measured using the self-reported QOL-AD questionnaire comprised of 13 questions with a scale of poor = 1, fair = 2, good = 3, excellent =4.
Scores range from 13 to 52, with higher scored indicating better quality of life.
|
every 2 weeks for up to one year
|
|
Change in sleep quality, as measured by the Pittsburgh Sleep Quality Index (PSQI)
Time Frame: every 2 weeks for up to one year
|
Measured using the self-reported PSQI that uses 9 questions regarding sleep quality to determine a final score where a total of "5" or greater is indicative of poor sleep quality.
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every 2 weeks for up to one year
|
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Change in dementia related behaviors and delirium, as measured by the Neuropsychiatric Inventory-Questionnaire (NPI-Q)
Time Frame: every 2 weeks for up to one year
|
Measured using the self-reported NPI-Q questionnaire that reports Yes = present or No = absent on 12 domains.
If yes, then the informant rates the severity of the symptoms on a 3-point scale (1 = mild, 2 = moderate, 3 = severe) and the distress of the symptoms on a 5-point scale (0 = not distressing at all, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = extreme or very severe).
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every 2 weeks for up to one year
|
|
Change in mood, as measured by the Patient Health Questionnaire 9 (PHQ-9)
Time Frame: every 2 weeks for up to one year
|
Measured using the self-reported PHQ-9 questionnaire that uses 9 question regarding patient health with a sale of not at all = 0, several days = 1, more than half the days = 2, nearly everyday =3.
Scores range from 0 to 27, with higher scored indicating grater severity of depression.
|
every 2 weeks for up to one year
|
|
Change in function and independence, as measured by the Katz Index of Independence in Activities of Daily living (KATZ)
Time Frame: every 2 weeks for up to one year
|
Measured using the self-reported KATZ questionnaire with a scale of independence = 1 and dependence = 0 to determine total score.
The KATZ ranges from 0 to 6 with the lower score indicated patient is very dependent and the higher score indicated patient is independent.
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every 2 weeks for up to one year
|
|
Change in medication use
Time Frame: every 2 weeks for up to one year
|
Measured using recorded medication use from patient's chart.
|
every 2 weeks for up to one year
|
|
Change in falls
Time Frame: monthly for up to one year
|
Measured using recorded fall data from patient's chart.
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monthly for up to one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in caregiver burden, as measured by the Caregiver Strain Index (CSI)
Time Frame: 6 months
|
Measured using the self-reported CSI questionnaire with a scale of Yes=1 and No=0.
Total score of 7 or higher indicates a high level of stress.
|
6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in emergency room and hospitalizations
Time Frame: monthly for up to one year
|
Measured using recorded emergency room and hospitalization data from patient's chart.
|
monthly for up to one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ying Ying Chen, MD, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 2, 2020
Primary Completion (Actual)
January 29, 2024
Study Completion (Actual)
June 9, 2025
Study Registration Dates
First Submitted
December 18, 2019
First Submitted That Met QC Criteria
April 14, 2020
First Posted (Actual)
April 16, 2020
Study Record Updates
Last Update Posted (Estimated)
August 29, 2025
Last Update Submitted That Met QC Criteria
August 25, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-002202
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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