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

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Retro-fitted room with technological enhancements

About this trial

This is an interventional health services research trial for Dementia

Eligibility Criteria

65 Years - 100 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Mayo Clinic in RochesterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Standard of Care Group

Arm Description

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

Outcomes

Primary Outcome Measures

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.

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.

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).

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.

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.

Change in medication use

Measured using recorded medication use from patient's chart.

Change in falls

Measured using recorded fall data from patient's chart.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT04350060

First Posted

December 18, 2019

Last Updated

May 26, 2023

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT04350060

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 2, 2020 (Actual)

Primary Completion Date

June 2024 (Anticipated)

Study Completion Date

June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dementia

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention Group

Arm Type

Experimental

Arm Description

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

Arm Title

Standard of Care Group

Arm Type

No Intervention

Intervention Type

Other

Intervention Name(s)

Retro-fitted room with technological enhancements

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in quality of life, as measured by the Quality of Life in Alzheimer's disease (QOL-AD)

Description

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.

Time Frame