Recruiting

Sleep Quality

Sponsor:

University of Alabama, Tuscaloosa

Code:

NCT05820919

Conditions

Alzheimer Disease

Dementia

Sleep Disorder

Sleep Disturbance

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

LOCK Sleep Program

No intervention (control period/baseline data collection)

Study Details

Brief summary:

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.

Conditions

Alzheimer Disease

Dementia

Sleep Disorder

Sleep Disturbance

Study ID

NCT05820919

Start date

Sep 7, 2023

Status verified date

Mar, 2024

Completion date

May 29, 2027

Anticipated

Primary completion date

Apr 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

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 Design

Enrollment

456 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Control (each NH acts as its own control):

Each nursing home serves as its own control. Control data will be collected for 1 week (then the intervention will begin).

experimental: Intervention (all NHs receive the intervention):

The intervention arm includes a ten-week active intervention phase, then a five-week sustainment phase.

Interventions

LOCK Sleep Program

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)

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

Primary outcome measure

  • Sleep (actigraph measurement) [ Time Frame: 15 week sleep intervention period ]

Central Contacts and Locations

Central contacts

Lynn Snow, PhD

205-201-0312LSNOW@ua.edu

Brian Cox, MS

205-348-7518brian.cox@ua.edu

Locations

Vivage/Beecan Corporation

Recruiting

Lakewood, Colorado, United States, 80228

Contacts

Hope Carwile, MSW

720-217-9043hcarwile@vivagebeecan.com

National HealthCare Corporation

Recruiting

Murfreesboro, Tennessee, United States, 37130

Contacts

Vicki Dodson, RN

vdodson@nhccare.com

Angela Westergard, LPN

615-631-6146angela.westergard@nhccare.com

Caraday Healthcare, LLC

Recruiting

San Marcos, Texas, United States, 78666

Contacts

Paul Gerharter, RN,C

512-641-8805pgerharter@caradayhealth.com

Catherine McGuire, RN,MPAff

cmcguire@caradayhealth.com

More Information

Sponsor

University of Alabama, Tuscaloosa

Last update posted

Mar 12, 2024

Last verified

Mar, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Alabama, Tuscaloosa on 2024-03-12.