Enhancing Sleep Quality for Nursing Home Residents With Dementia (40Winks)

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

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.

Study Overview

• Status: Completed
• Conditions: Sleep Disorder; Dementia; Alzheimer Disease; Sleep Disturbance
• Intervention / Treatment: Behavioral: LOCK sleep intervention

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 Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Tuscaloosa, Alabama, United States, 35487-0348
      • The University of Alabama

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 46 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LOCK sleep intervention; Nursing home staff receive the LOCK sleep intervention training and thus provide to nursing home residents with dementia the LOCK sleep 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep (Actigraph Measurement)	Total sleep time (total minutes asleep each nighttime period - 7pm to 7am)	15 week sleep intervention period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychotropic medication use (change from baseline - decrease, increase, same)	As recorded in the Minimum Data Set's Medications received subscale, Antipsychotic medication question, and Psychotropic Drug Care Area Trigger Code. The Medications received subscale asks if the resident has received any antipsychotic, antianxiety or antidepressant medication in the past seven days or since admission/reentry if less than seven days. The Antipsychotic medication, similar to in the previous subscale, asks whether the resident received antipsychotic medications since admission/entry or reentry or the prior OBRA assessment, whichever is more recent. Finally, the Psychotropic Drug Trigger Code asks whether the Psychotropic Drug Use Care Area was triggered. These are MDS items N0410A-C, N0450A, and V0200A17A, respectively. These data will be consolidated into a trichotomous indicator of change from baseline (decrease, increase, same).	15 week sleep intervention period
Pain treatment received (change from baseline - decrease, increase, same)	Based on the Pain Management items as recorded in the Minimum Data Set. The Pain Management sub scale asks, using yes or no questions, if the resident has been on a scheduled pain medication regimen, received PRN pain medication or was offered and declined, and, has received non-medication intervention for pain in the past five days. These data will be consolidated into a trichotomous indicator of change from baseline (decrease, increase, same).	15 week sleep intervention period
Pain - Resident Report (change from baseline - decrease, increase, same)	Based on the Pain Assessment items as recorded in the Minimum Data Set. The Pain Assessment sub scale asks if the resident has had pain or hurting (yes, no), the frequency of pain or hurting (almost constantly, frequently, occasionally, rarely), if the resident had difficulty sleeping because of pain or hurting (yes, no), if the residents day-to-day activities were limited because of pain or hurting (yes, no) over the past five days. The Pain Intensity sub scale asks the residents numeric pain rating value (0-10 scale) and intensity of worst pain experienced (mild, moderate, severe, very severe or horrible) in the past five days. These data will be consolidated into a trichotomous indicator of change from baseline (decrease, increase, same).	15 week sleep intervention period
Pain - Staff Report (change from baseline - decrease, increase, same)	As recorded in the Minimum Data Set, the Staff Assessment sub scale asks staff members, all yes, no responses, if the resident had non-verbal sounds, verbal complaints, facial expressions, protective body movements or postures, or no signs that may be an indicator of possible pain in the last five days. These data will be consolidated into a trichotomous indicator of change from baseline (decrease, increase, same).	15 week sleep intervention period
Activities of daily living decline (change from baseline - decrease, increase, same)	Has activities of daily living functional ability declined from baseline. Based on Minimum Data Set items assessing decline in activities of daily living (MDS; G0110A-J & G0120A-B; QM N028.01), these data will be consolidated into a trichotomous indicator of change from baseline (decrease, increase, same)	15 week sleep intervention period

Collaborators and Investigators

• Sponsor: University of Alabama, Tuscaloosa
• Collaborators: The University of Texas Health Science Center, Houston; Brown University; University of Texas at Austin; University of Massachusetts, Lowell
• Investigators: Principal Investigator: Lynn Snow, PhD, The University of Alabama

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2021
• Primary Completion (Actual): August 31, 2022
• Study Completion (Actual): August 31, 2022

Study Registration Dates

• First Submitted: August 22, 2020
• First Submitted That Met QC Criteria: August 27, 2020
• First Posted (Actual): September 1, 2020

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: December 19, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurocognitive Disorders; Neurodegenerative Diseases; Tauopathies; Sleep Wake Disorders; Dyssomnias; Parasomnias; Dementia; Alzheimer Disease
• Other Study ID Numbers: 1R61AG065619-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Within 6 months of study closure, for 5 years
• IPD Sharing Access Criteria: Under development. Contact PI.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No