Enhancing Sleep Quality for Nursing Home Residents With Dementia

Study Overview
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Brief Summary
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This study sought to prepare for a full clinical trial aiming to improve clinical outcomes for an important, growing, and vulnerable population-nursing home (NH) residents with Alzheimer's disease or related dementias (ADRDs)-by piloting the research methods and intervention needed for an implementation trial (hybrid type III) of an evidence-based intervention (LOCK) to improve NH residents' sleep.

Detailed Description
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In community (non-VA) NHs [one from each of 3 national NH corporations], our multi-disciplinary team achieved two aims: (1) refine the LOCK sleep program to focus on sleep for residents with ADRD during this pilot (R61) phase, (2) which will prepare the team for the next phase of this NIH-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: Refine the LOCK sleep program train-the-trainer protocol by implementing and pilot-testing in three NHs. 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.

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

Conditions
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Alzheimer Disease, Dementia, Sleep Disorder, Sleep Disturbance

Intervention / Treatment
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* Behavioral: LOCK sleep intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Pilot study in 3 nursing homes. The pilot phase would inform the next phase, a clinical trial using an incomplete, stepped, wedge cluster randomized controlled trial (RCT) design with 24 nursing homes. Each nursing home in the full clinical trial would act as its own control (4 staggered steps, with 6 nursing homes per step).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LOCK sleep intervention<br>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<br>* Nursing home staff are trained to use a collaborative problem-solving approach to sleep quality improvement using front-line huddling<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep (actigraph measurement) | Total sleep time (total minutes asleep each nighttime period - 10pm 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 |