Enhancing Sleep Quality for Nursing Home Residents With Dementia

Alzheimer Disease Clinical Trial

— 40Winks  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04533815
• Other study ID #: 1R61AG065619-01
• Status: Completed
• Phase: N/A
• Start date: May 5, 2021
• Est. completion date: August 31, 2022

Study information

• Verified date: December 2023
• Source: University of Alabama, Tuscaloosa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia
• Dyssomnias
• Parasomnias
• Sleep Disorder
• Sleep Disturbance
• Sleep Wake Disorders

Intervention

Behavioral:
• LOCK sleep intervention
Nursing home staff are trained to use a collaborative problem-solving approach to sleep quality improvement using front-line huddling

Locations

Country	Name	City	State
United States	The University of Alabama	Tuscaloosa	Alabama

Sponsors (5)

Lead Sponsor	Collaborator
University of Alabama, Tuscaloosa	Brown University, The University of Texas Health Science Center, Houston, University of Massachusetts, Lowell, University of Texas at Austin

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep (Actigraph Measurement)	Total sleep time (total minutes asleep each nighttime period - 7pm to 7am)	15 week sleep intervention period