Enhancing Sleep Quality for Nursing Home Residents With Dementia

Not Applicable

Completed

• Conditions: Sleep Disturbance; Alzheimer Disease; Dementia; Sleep Disorder

• Registration Number: NCT04533815
• Lead Sponsor: University of Alabama, Tuscaloosa

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.

Study Timeline

• Study First Submitted: 2020-08-22
• Study First Submitted QC: 2020-08-27
• Study First Posted: 2020-09-01
• Study Start: 2021-05-05
• Primary Completion: 2022-08-31
• Study Completion: 2022-08-31
• Status Verified: 2023-12
• Results First Submitted: 2023-12-19
• Results First Submitted QC: 2023-12-19
• Last Update Submitted: 2023-12-19
• Results First Posted: 2024-01-10
• Last Update Posted: 2024-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Sleep (Actigraph Measurement)	15 week sleep intervention period	Total sleep time (total minutes asleep each nighttime period - 7pm to 7am)

Trial Locations

Locations (1)

The University of Alabama; 🇺🇸 Tuscaloosa, Alabama, United States