Improving the Quality of Dementia Care Through Innovative Redesign of the Memory Care Environment

Not Applicable

Recruiting

• Conditions: Dementia
• Interventions: Other: Retro-fitted room with technological enhancements

• Registration Number: NCT04350060
• Lead Sponsor: Mayo Clinic

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-18
• Study Start: 2020-02-02
• Study First Submitted QC: 2020-04-14
• Study First Posted: 2020-04-16
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-31
• Primary Completion: 2025-12
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Retro-fitted room with technological enhancements	Subjects with dementia will be living in a retro-fitted room with technological enhancements for a 12 month period.

Primary Outcome Measures

Name	Time	Method
Change in function and independence, as measured by the Katz Index of Independence in Activities of Daily living (KATZ)	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.
Change in quality of life, as measured by the Quality of Life in Alzheimer's disease (QOL-AD)	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.
Change in sleep quality, as measured by the Pittsburgh Sleep Quality Index (PSQI)	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.
Change in dementia related behaviors and delirium, as measured by the Neuropsychiatric Inventory-Questionnaire (NPI-Q)	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).
Change in mood, as measured by the Patient Health Questionnaire 9 (PHQ-9)	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.
Change in medication use	every 2 weeks for up to one year	Measured using recorded medication use from patient's chart.
Change in falls	monthly for up to one year	Measured using recorded fall data from patient's chart.

Secondary Outcome Measures

Name	Time	Method
Change in caregiver burden, as measured by the Caregiver Strain Index (CSI)	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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States