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Clinical Trials/NCT04533815
NCT04533815
Completed
Not Applicable

Enhancing Sleep Quality for Nursing Home Residents With Dementia: Pragmatic Trial of an Evidence-Based Frontline Huddling Program

University of Alabama, Tuscaloosa1 site in 1 country23 target enrollmentMay 5, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alzheimer Disease
Sponsor
University of Alabama, Tuscaloosa
Enrollment
23
Locations
1
Primary Endpoint
Sleep (Actigraph Measurement)
Status
Completed
Last Updated
2 years ago

Overview

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.

Detailed Description

In community (non-VA) NHs \[one from each of 3 national NH corporations\], the multi-disciplinary research team achieved two aims: (1) refined the LOCK program to focus on sleep for residents with ADRD during this pilot (R61) phase, (2) which prepared the team for the second phase of this two-part NIA-funded grant (the R33 phase) to test the impact and sustainability of this intervention for NH residents with ADRD in an incomplete stepped-wedge randomized controlled trial. THIS PILOT STUDY R61 PHASE (1 YEAR; N = 3 NHS; 1 NH PER CORPORATION) HAD THE FOLLOWING SPECIFIC AIMS: 1. Refine the LOCK sleep program train-the-trainer protocol by implementing and pilot-testing in three NHs. 2. Test and refine the research methods to: effectively identify eligible NHs and residents; obtain consent; collect primary data from residents and staff (sleep time via actigraph); explore staff impressions of additional sleep measurement devices (Fitbits); transfer primary and secondary data to our data center; and merge all data.

Registry
clinicaltrials.gov
Start Date
May 5, 2021
End Date
August 31, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
University of Alabama, Tuscaloosa
Responsible Party
Principal Investigator
Principal Investigator

A. Lynn Snow

Professor

University of Alabama, Tuscaloosa

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Sleep (Actigraph Measurement)

Time Frame: 15 week sleep intervention period

Total sleep time (total minutes asleep each nighttime period - 7pm to 7am)

Study Sites (1)

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