40Winks: Enhancing Sleep Quality for Nursing Home Residents With Dementia

Sponsor
University of Alabama, Tuscaloosa (Other)
Overall Status
Recruiting
CT.gov ID
NCT04533815
Collaborator
University of Massachusetts, Lowell (Other), The University of Texas Health Science Center, Houston (Other), University of Texas at Austin (Other), Brown University (Other)
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Study Details

Study Description

Brief Summary

This study will improve clinical outcomes for an important, growing, and vulnerable population-nursing home (NH) residents with Alzheimer's disease or related dementias (ADRDs)-by implementing an evidence-based intervention (LOCK) to improve these residents' sleep. It will also significantly increase our understanding of how to implement and sustain nursing home interventions.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: LOCK sleep intervention
N/A

Detailed Description

In community (non-VA) NHs [one from each of 3 NH corporations, still to be recruited], our multi-disciplinary team proposes to (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 CURRENT PILOT STUDY R61 PHASE (1 YEAR; N = 3 NHS; 1 NH PER CORPORATION) HAS 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 Design

Study Type:
Interventional
Anticipated Enrollment :
57 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
pilot study in 3 nursing homes. The pilot phase will 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 will act as its own control (6 staggered steps, with 4 nursing homes per step).pilot study in 3 nursing homes. The pilot phase will 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 will act as its own control (6 staggered steps, with 4 nursing homes per step).
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Enhancing Sleep Quality for Nursing Home Residents With Dementia: Pragmatic Trial of an Evidence-Based Frontline Huddling Program
Actual Study Start Date :
May 5, 2021
Anticipated Primary Completion Date :
Aug 31, 2022
Anticipated Study Completion Date :
Aug 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Sleep (actigraph measurement) [6 week sleep intervention period]

    Total sleep time (total minutes asleep each nighttime period - 10pm to 6am)

Secondary Outcome Measures

  1. Psychotropic medication use (change from baseline - decrease, increase, same) [6 week sleep intervention period]

    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).

  2. Pain treatment received (change from baseline - decrease, increase, same) [6 week sleep intervention period]

    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).

  3. Pain - Resident Report (change from baseline - decrease, increase, same) [6 week sleep intervention period]

    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).

  4. Pain - Staff Report (change from baseline - decrease, increase, same) [6 week sleep intervention period]

    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).

  5. Activities of daily living decline (change from baseline - decrease, increase, same) [6 week sleep intervention period]

    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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The University of Alabama Tuscaloosa Alabama United States 35487-0348

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Lynn Snow, PhD, The University of Alabama

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
A. Lynn Snow, Professor, University of Alabama, Tuscaloosa
ClinicalTrials.gov Identifier:
NCT04533815
Other Study ID Numbers:
  • 1R61AG065619-01
First Posted:
Sep 1, 2020
Last Update Posted:
Jan 18, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 18, 2022