Trial Radar AI | ||
|---|---|---|
Clinical Trial NCT05820919 (40Winks) for Alzheimer Disease, Dementia, Sleep Disorder, Sleep Disturbance is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
One study matched filter criteria
Card View
Enhancing Sleep Quality for Nursing Home Residents With Dementia - R33 Phase (40Winks) 456
Clinical Trial NCT05820919 (40Winks) is an interventional study for Alzheimer Disease, Dementia, Sleep Disorder, Sleep Disturbance that is recruiting. It started on September 7, 2023 with plans to enroll 456 participants. Led by University of Alabama, Tuscaloosa, it is expected to complete by May 29, 2027. The latest data from ClinicalTrials.gov was last updated on March 12, 2024.
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.
Detailed Description
Disturbed sleep places older adults at higher risk for frailty, morbidity, and even mortality. Yet nursing home (NH) routines frequently disturb residents' sleep through use of noise and light or efforts, for example, to reduce incontinence. NH residents with Alzheimer's disease or related dementias-almost two-thirds of long-stay NH residents-are likely to be particularly affected by sleep disturbance. This study tac...Show More
Official Title
Enhancing Sleep Quality for Nursing Home Residents With Dementia: Pragmatic Trial of an Evidence-Based Frontline Huddling Program
Conditions
Alzheimer DiseaseDementiaSleep DisorderSleep DisturbanceOther Study IDs
NCT ID Number
Start Date (Actual)
2023-09-07
Last Update Posted
2024-03-12
Completion Date (Estimated)
2027-05-29
Enrollment (Estimated)
456
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
OtherControl (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). | No intervention (control period/baseline data collection) Each NH serves as its own control. During the control period, baseline data will be collected. |
ExperimentalIntervention (all NHs receive the intervention): The intervention arm includes a ten-week active intervention phase, then a five-week sustainment phase. | 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 ...Show More |
Primary Outcome Measures
Secondary 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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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). | 15 week sleep intervention period |
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). | 15 week sleep intervention period |
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). | 15 week sleep intervention period |
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). | 15 week sleep intervention period |
Activities of daily living decline | 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 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
50 Years
Eligible Sexes
All
- 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
- 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 Responsible Party
A. Lynn Snow, Principal Investigator, Professor, University of Alabama, Tuscaloosa
Study Central Contact
Contact: Lynn Snow, PhD, 205-201-0312, [email protected]
Contact: Brian Cox, MS, 205-348-7518, [email protected]
3 Study Locations in 1 Countries
Colorado
Vivage/Beecan Corporation, Lakewood, Colorado, 80228, United States
Hope Carwile, MSW, Contact, 720-217-9043, [email protected]
Recruiting
Tennessee
National HealthCare Corporation, Murfreesboro, Tennessee, 37130, United States
Vicki Dodson, RN, Contact, [email protected]
Angela Westergard, LPN, Contact, 615-631-6146, [email protected]
Recruiting
Texas
Caraday Healthcare, LLC, San Marcos, Texas, 78666, United States
Paul Gerharter, RN,C, Contact, 512-641-8805, [email protected]
Catherine McGuire, RN,MPAff, Contact, [email protected]
Recruiting