Dementia Clinical Trial
Official title:
Memory Care of the Future: Improving the Quality of Dementia Care Through Innovative Redesign of the Memory Care Environment
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 |
Verified date | June 2024 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Research study is being done to demonstrate novel opportunities to transform the way the dementia community is cared for.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic in Rochester | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
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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