Enhancing Sleep Quality for Nursing Home Residents With Dementia - R33 Phase
40Winks
1 other identifier
interventional
456
1 country
3
Brief Summary
This study seeks to improve clinical outcomes for an important, growing, and vulnerable population-nursing home residents with Alzheimer's disease or related dementias-by testing an evidence-based intervention to improve these residents' sleep. It will also examine the implementation and sustainment of this intervention.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable alzheimer-disease
Started Sep 2023
Typical duration for not_applicable alzheimer-disease
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 7, 2023
CompletedFirst Posted
Study publicly available on registry
April 20, 2023
CompletedStudy Start
First participant enrolled
September 7, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 29, 2027
ExpectedMarch 12, 2024
March 1, 2024
2.6 years
April 7, 2023
March 11, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Sleep (actigraph measurement)
Total sleep time (total minutes asleep each nighttime period - 10pm to 7am)
15 week sleep intervention period
Secondary Outcomes (5)
Psychotropic medication use
15 week sleep intervention period
Pain treatment received
15 week sleep intervention period
Pain - Resident Report
15 week sleep intervention period
Pain - Staff Report
15 week sleep intervention period
Activities of daily living decline
15 week sleep intervention period
Study Arms (2)
Control (each NH acts as its own control):
OTHEREach nursing home serves as its own control. Control data will be collected for 1 week (then the intervention will begin).
Intervention (all NHs receive the intervention):
EXPERIMENTALThe intervention arm includes a ten-week active intervention phase, then a five-week sustainment phase.
Interventions
The LOCK sleep program is a program that trains NH staff in a NH frontline staff huddling approach. It is derived from evidence supporting strengths-based learning, systematic observation, relationship-based teamwork, and efficiency. Staff learn how to work together as a team to collaboratively problem-solving about resident sleep challenges (e.g., evidence-based sleep promoting best practices and daytime meaningful activity best practices).
Each NH serves as its own control. During the control period, baseline data will be collected.
Eligibility Criteria
You may qualify if:
- Nursing home residents aged \>=50 years with an Alzheimer disease or related dementia (ADRD) diagnosis, identified by nursing home staff participating in frontline LOCK sleep huddles as having sleep problems
You may not qualify if:
- Residents with a high risk of OSA who are not being treated for OSA because actigraph measurements are inaccurate in that population.
- Residents who have a persistent bilateral resting tremor or paralysis in both arms (a subset of persons with Parkinson's disease and related significant tremor-causing diagnoses), due to actigraph measurement inaccuracies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Alabama, Tuscaloosalead
- University of Massachusetts, Lowellcollaborator
- The University of Texas Health Science Center, Houstoncollaborator
- University of Texas at Austincollaborator
- Brown Universitycollaborator
Study Sites (3)
Vivage/Beecan Corporation
Lakewood, Colorado, 80228, United States
National HealthCare Corporation
Murfreesboro, Tennessee, 37130, United States
Caraday Healthcare, LLC
San Marcos, Texas, 78666, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lynn Snow, PhD
The University of Alabama
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 7, 2023
First Posted
April 20, 2023
Study Start
September 7, 2023
Primary Completion
April 1, 2026
Study Completion (Estimated)
May 29, 2027
Last Updated
March 12, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data will become available no later than 1 year after data collection is completed and will remain available for 1 year.
- Access Criteria
- Interested parties will be invited to submit access requests and plan for use of data. Data use plans will be reviewed for scientific merit and ethics.
We will share de-identified participant data by depositing data files and associated code books and analysis files with the data repository dataverse (dataverse.org). We will follow the University of Alabama IRB guidance and approval for ensuring that our data is appropriately de-identified before posting to dataverse. Our IRB-approved informed consent and HIPPAA forms seek participant permission for broad inclusion of participant data for these data sharing and secondary analysis purposes. We do not have authority to share Minimum Data Set (MDS) data, so we cannot deposit these data directly. However, we will share our analysis files and instructions on how to work with the federal owners of these data to request access; in this way other researchers will be able to replicate our steps in constructing the MDS data sets once they obtain the data from the federal owners (who do provide the data to the public via a standardized credentialed request process for a fee).