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R33AG065619

Project Grant

Overview

Grant Description
Enhancing sleep quality for nursing home residents with dementia: pragmatic trial - Disturbed sleep places older adults at higher risk for frailty, morbidity, and even mortality. Yet nursing home (NH) routines frequently disturb residents' sleep through use of noise and light or efforts, for example, to reduce incontinence.

NH residents with Alzheimer's disease or related dementias (ADRD)—almost two-thirds of long-stay NH residents—are likely to be particularly affected by sleep disturbance. This study tackles these important issues and substantially moves forward goals of the National Plan to Address Alzheimer's Disease 2018 Update by proposing to implement an evidence-based intervention to improve sleep: a NH frontline staff huddling program known as LOCK.

The LOCK program is derived from evidence supporting strengths-based learning, systematic observation, relationship-based teamwork, and efficiency. A LOCK program pilot targeting staff-resident interactions enabled 6 Veterans Health Administration (VA) NHs make meaningful quantitative and qualitative improvements. Preliminary qualitative data from a national VA roll out show that the program is effective when targeting resident clinical outcomes such as pain and pressure ulcers. The program's methods have also improved clinical care in non-VA NHs.

This proposal is therefore an NIH Stage III, real-world hybrid efficacy-effectiveness pragmatic trial of the LOCK program for sleep (LOCK Sleep Program). In non-VA NHs from 3 NH corporations, the study will (1) refine the LOCK program to focus on sleep for residents with ADRD in an R61 phase, (2) test the impact of the LOCK Sleep Program for NH residents with ADRD in an R33 phase, and (3) evaluate the program's sustainability.

The R61 phase (1 year; N = 3 NHs; 1 NH per corporation) has the following specific aims: (1) refine the LOCK Sleep Program train-the-trainer protocol by implementing and pilot-testing it. (2) Refine the research methods to effectively identify eligible NHs and residents, obtain consent, collect primary data from residents and staff, explore staff impressions of additional sleep measurement devices (Fitbits), transfer primary and secondary data to our data center, and merge all data.

After successfully completing designated R61 milestones and refining the intervention methods, we will conduct a wedge-design randomized, controlled trial. The R33 phase (4 years; N = 24 NHs; 8 NHs per corporation) has the following specific aims: (1) implement the LOCK-based sleep program for residents with ADRD using the train-the-trainer model. (2) Estimate impact of the LOCK Sleep Program on sleep (primary outcome) and on psychotropic medication use, pain and analgesic medication use, and activities of daily living decline (secondary outcomes). (3) Examine factors, using mixed methods, associated with variation in the program's implementation and its sustainability.

This innovative program also has future potential to address other important issues (safety, infection control) and expand to other settings (assisted living, inpatient mental health). The study's strong team, careful consideration of design challenges, and resulting rigorous, pragmatic approach will ensure success of this promising intervention for NH residents with ADRD.
Funding Goals
TO ENCOURAGE BIOMEDICAL, SOCIAL, AND BEHAVIORAL RESEARCH AND RESEARCH TRAINING DIRECTED TOWARD GREATER UNDERSTANDING OF THE AGING PROCESS AND THE DISEASES, SPECIAL PROBLEMS, AND NEEDS OF PEOPLE AS THEY AGE. THE NATIONAL INSTITUTE ON AGING HAS ESTABLISHED PROGRAMS TO PURSUE THESE GOALS. THE DIVISION OF AGING BIOLOGY EMPHASIZES UNDERSTANDING THE BASIC BIOLOGICAL PROCESSES OF AGING. THE DIVISION OF GERIATRICS AND CLINICAL GERONTOLOGY SUPPORTS RESEARCH TO IMPROVE THE ABILITIES OF HEALTH CARE PRACTITIONERS TO RESPOND TO THE DISEASES AND OTHER CLINICAL PROBLEMS OF OLDER PEOPLE. THE DIVISION OF BEHAVIORAL AND SOCIAL RESEARCH SUPPORTS RESEARCH THAT WILL LEAD TO GREATER UNDERSTANDING OF THE SOCIAL, CULTURAL, ECONOMIC AND PSYCHOLOGICAL FACTORS THAT AFFECT BOTH THE PROCESS OF GROWING OLD AND THE PLACE OF OLDER PEOPLE IN SOCIETY. THE DIVISION OF NEUROSCIENCE FOSTERS RESEARCH CONCERNED WITH THE AGE-RELATED CHANGES IN THE NERVOUS SYSTEM AS WELL AS THE RELATED SENSORY, PERCEPTUAL, AND COGNITIVE PROCESSES ASSOCIATED WITH AGING AND HAS A SPECIAL EMPHASIS ON ALZHEIMER'S DISEASE. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM: TO EXPAND AND IMPROVE THE SBIR PROGRAM, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM: TO STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO FOSTER TECHNOLOGY TRANSFER BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION.
Grant Program (CFDA)
Place of Performance
Tuscaloosa, Alabama 35487 United States
Geographic Scope
Single Zip Code
Analysis Notes
Amendment Since initial award the total obligations have increased 162% from $1,961,090 to $5,146,963.
University Of Alabama was awarded LOCK Sleep Program: Enhancing Dementia Residents' Sleep Project Grant R33AG065619 worth $5,146,963 from National Institute on Aging in September 2019 with work to be completed primarily in Tuscaloosa Alabama United States. The grant has a duration of 7 years 7 months and was awarded through assistance program 93.866 Aging Research. The Project Grant was awarded through grant opportunity Pragmatic Trials for Dementia Care in Long-term Services and Support (LTSS) Settings (R61/R33 - Clinical Trial Required).

Status
(Ongoing)

Last Modified 7/3/25

Period of Performance
9/15/19
Start Date
4/30/27
End Date
81.0% Complete

Funding Split
$5.1M
Federal Obligation
$0.0
Non-Federal Obligation
$5.1M
Total Obligated
100.0% Federal Funding
0.0% Non-Federal Funding

Activity Timeline

Interactive chart of timeline of amendments to R33AG065619

Subgrant Awards

Disclosed subgrants for R33AG065619

Transaction History

Modifications to R33AG065619

Additional Detail

Award ID FAIN
R33AG065619
SAI Number
R33AG065619-970129136
Award ID URI
SAI UNAVAILABLE
Awardee Classifications
Public/State Controlled Institution Of Higher Education
Awarding Office
75NN00 NIH National Insitute on Aging
Funding Office
75NN00 NIH National Insitute on Aging
Awardee UEI
RCNJEHZ83EV6
Awardee CAGE
77223
Performance District
AL-07
Senators
Tommy Tuberville
Katie Britt

Budget Funding

Federal Account Budget Subfunction Object Class Total Percentage
National Institute on Aging, National Institutes of Health, Health and Human Services (075-0843) Health research and training Grants, subsidies, and contributions (41.0) $2,042,212 100%
Modified: 7/3/25