Enhancing Sleep Quality for Nursing Home Residents With Dementia - R33 Phase

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorUniversity of Alabama, Tuscaloosa

About this trial

This study seeks to improve clinical outcomes for an important, growing, and vulnerable population-nursing home residents with Alzheimer's disease or related dementias-by testing an evidence-based intervention to improve these residents' sleep. It will also examine the implementation and sustainment of this intervention.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • LOCK Sleep Program

    Behavioral

    The LOCK sleep program is a program that trains NH staff in a NH frontline staff huddling approach. It is derived from evidence supporting strengths-based learning, systematic observation, relationship-based teamwork, and efficiency. Staff learn how to work together as a team to collaboratively problem-solving about resident sleep challenges (e.g., evidence-based sleep promoting best practices and daytime meaningful activity best practices).

  • No intervention (control period/baseline data collection)

    Other intervention

    Each NH serves as its own control. During the control period, baseline data will be collected.

Treatment groups

456 Participants
are divided into 2 treatment groups
Group A: Control (each NH acts as its own control):Other 1 intervention
Group B: Intervention (all NHs receive the intervention):Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Sleep (actigraph measurement)

Total sleep time (total minutes asleep each nighttime period - 10pm to 7am)

Time frame
15 week sleep intervention period

Secondary outcomes

1

Psychotropic medication use

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).

Time frame
15 week sleep intervention period
2

Pain treatment received

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).

Time frame
15 week sleep intervention period
3

Pain - Resident Report

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).

Time frame
15 week sleep intervention period
4

Pain - Staff Report

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).

Time frame
15 week sleep intervention period

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alabama, Tuscaloosa

Lead sponsor

University of Massachusetts, Lowell

Collaborator

The University of Texas Health Science Center, Houston

Collaborator

University of Texas at Austin

Collaborator

Brown University

Collaborator