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

NCT04350060 | Completed

• 1 other identifier: 18-002202
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dementia

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• Change in medication use

  Measured using recorded medication use from patient's chart.

  every 2 weeks for up to one year

• Change in falls

  Measured using recorded fall data from patient's chart.

  monthly for up to one year

Secondary Outcomes (1)

• Change in caregiver burden, as measured by the Caregiver Strain Index (CSI)

  6 months

Other Outcomes (1)

• Change in emergency room and hospitalizations

  monthly for up to one year

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Other: Retro-fitted room with technological enhancements

Standard of Care Group

NO INTERVENTION

Interventions

Retro-fitted room with technological enhancements OTHER

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.

Intervention Group

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients currently residing at Arbor Terrace memory care unit
• Patients diagnosed with dementia

You may not qualify if:

• Hospice patients with less than 30 days of life expectancy at the time of enrollment

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Ying Ying Chen, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 18, 2019
• First Posted: April 16, 2020
• Study Start: February 2, 2020
• Primary Completion: January 29, 2024
• Study Completion: June 9, 2025
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)