Enhancing Sleep Quality for Nursing Home Residents With Dementia
40Winks
1 other identifier
interventional
23
1 country
1
Brief Summary
This was a pilot study (R61) to prepare for a full clinical trial (R33) aiming to improve clinical outcomes for an important, growing, and vulnerable population-nursing home (NH) residents with Alzheimer's disease or related dementias (ADRDs). The goal was to pilot and refine the research methods and intervention that would be subsequently evaluated in a full implementation trial (hybrid type III). The goal of the evidence-based intervention (LOCK) that was refined in this pilot study and will be evaluated in the subsequent full clinical trial is to improve the sleep of NH residents with ADRD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable alzheimer-disease
Started May 2021
Shorter than P25 for not_applicable alzheimer-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 22, 2020
CompletedFirst Posted
Study publicly available on registry
September 1, 2020
CompletedStudy Start
First participant enrolled
May 5, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2022
CompletedResults Posted
Study results publicly available
January 10, 2024
CompletedJanuary 10, 2024
December 1, 2023
1.3 years
August 22, 2020
December 19, 2023
December 19, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Sleep (Actigraph Measurement)
Total sleep time (total minutes asleep each nighttime period - 7pm to 7am)
15 week sleep intervention period
Study Arms (1)
LOCK sleep intervention
EXPERIMENTALNursing home staff receive the LOCK sleep intervention training and thus provide to nursing home residents with dementia the LOCK sleep intervention
Interventions
Nursing home staff are trained to use a collaborative problem-solving approach to sleep quality improvement using front-line huddling
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 (1)
The University of Alabama
Tuscaloosa, Alabama, 35487-0348, United States
Related Publications (1)
Snow AL, Loup J, Morgan RO, Richards K, Parmelee PA, Baier RR, McCreedy E, Frank B, Brady C, Fry L, McCullough M, Hartmann CW. Enhancing sleep quality for nursing home residents with dementia: a pragmatic randomized controlled trial of an evidence-based frontline huddling program. BMC Geriatr. 2021 Apr 27;21(1):281. doi: 10.1186/s12877-021-02189-8.
PMID: 33906631BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Lynn Snow
- Organization
- University of Alabama
Study Officials
- PRINCIPAL INVESTIGATOR
Lynn Snow, PhD
The University of Alabama
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 22, 2020
First Posted
September 1, 2020
Study Start
May 5, 2021
Primary Completion
August 31, 2022
Study Completion
August 31, 2022
Last Updated
January 10, 2024
Results First Posted
January 10, 2024
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- Within 6 months of study closure, for 5 years
- Access Criteria
- Under development. Contact PI.
The research team will share de-identified participant data by depositing data files and associated code books and analysis files with the data repository dataverse (dataverse.org). The research team will follow the University of Alabama IRB guidance and approval for ensuring that the data is appropriately de-identified before posting to dataverse. The IRB-approved informed consent and HIPPAA forms seek participant permission for broad inclusion of participant data for these data sharing and secondary analysis purposes.