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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04350060
Other study ID # 18-002202
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 2, 2020
Est. completion date June 2024

Study information

Verified date June 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Research study is being done to demonstrate novel opportunities to transform the way the dementia community is cared for.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date June 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group 65 Years to 100 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Retro-fitted room with technological enhancements
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.

Locations

Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Change in emergency room and hospitalizations Measured using recorded emergency room and hospitalization data from patient's chart. monthly for up to one year
Primary Change in quality of life, as measured by the Quality of Life in Alzheimer's disease (QOL-AD) 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
Primary Change in sleep quality, as measured by the Pittsburgh Sleep Quality Index (PSQI) 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. every 2 weeks for up to one year
Primary Change in dementia related behaviors and delirium, as measured by the Neuropsychiatric Inventory-Questionnaire (NPI-Q) 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). every 2 weeks for up to one year
Primary Change in mood, as measured by the Patient Health Questionnaire 9 (PHQ-9) 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
Primary Change in function and independence, as measured by the Katz Index of Independence in Activities of Daily living (KATZ) 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. every 2 weeks for up to one year
Primary Change in medication use Measured using recorded medication use from patient's chart. every 2 weeks for up to one year
Primary Change in falls Measured using recorded fall data from patient's chart. monthly for up to one year
Secondary Change in caregiver burden, as measured by the Caregiver Strain Index (CSI) 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
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