Enhancing Sleep Quality for Nursing Home Residents With Dementia - R33 Phase
Part of paid clinical trials in Lakewood, Colorado.
- Sponsor
- University of Alabama, Tuscaloosa
- Study ID
- NCT05820919
- Status
- Recruiting
Conditions
- Alzheimer Disease
- Dementia
- Sleep Disorder
- Sleep Disturbance
Eligibility Criteria
- Sex
- ALL
- Age
- 50 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- LOCK Sleep Program — BEHAVIORALThe 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) — OTHEREach NH serves as its own control. During the control period, baseline data will be collected.
Study Details
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.
Key Dates
- Start date
- Sep 7, 2023
- Status verified
- Mar 2024
- Primary completion
- Apr 1, 2026
- Completion
- May 29, 2027
Study Design
- Enrollment
- 456 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
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.
Primary Outcome Measure
Sleep (actigraph measurement) [ Time Frame: 15 week sleep intervention period ]
Central Contacts
- Lynn Snow, PhD205-201-0312
- Brian Cox, MS205-348-7518
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Vivage/Beecan Corporation | Lakewood | Colorado | 80228 | |
| National HealthCare Corporation | Murfreesboro | Tennessee | 37130 | Vicki Dodson, RN |
| Caraday Healthcare, LLC | San Marcos | Texas | 78666 | Catherine McGuire, RN,MPAff |
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