Enhancing Sleep Quality for Nursing Home Residents With Dementia

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-05

Study Completion Date

2022-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This was a pilot study (R61) to prepare for a full clinical trial (R33) aiming to improve clinical outcomes for an important, growing, and vulnerable population-nursing home (NH) residents with Alzheimer's disease or related dementias (ADRDs). The goal was to pilot and refine the research methods and intervention that would be subsequently evaluated in a full implementation trial (hybrid type III). The goal of the evidence-based intervention (LOCK) that was refined in this pilot study and will be evaluated in the subsequent full clinical trial is to improve the sleep of NH residents with ADRD.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT05820919

Alzheimer Disease Dementia Sleep Disorder +1 more

RECRUITING NA

Acceptance and Commitment Therapy for Family Caregivers of People With Dementia

NCT04458870

Psychological Distress

COMPLETED NA

Automated, Assistive, Non-Contact Sleep Quality Monitor for Individuals With Alzheimer's Disease

NCT06045988

Alzheimer Disease Dementia Sleep Disturbance

NOT_YET_RECRUITING NA

A Ten-Week Online Acceptance and Commitment Therapy Intervention for Family Caregivers of People With Dementia

NCT05043441

Depressive Symptoms

COMPLETED NA

Hypnosis for Sleep Quality in Caregivers of Individuals With Alzheimer's Disease

NCT04779866

Poor Quality Sleep Caregiver Stress Alzheimer's Disease (Incl Subtypes)

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

In community (non-VA) NHs \[one from each of 3 national NH corporations\], the multi-disciplinary research team achieved two aims: (1) refined the LOCK program to focus on sleep for residents with ADRD during this pilot (R61) phase, (2) which prepared the team for the second phase of this two-part NIA-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 PILOT STUDY R61 PHASE (1 YEAR; N = 3 NHS; 1 NH PER CORPORATION) HAD 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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alzheimer Disease Dementia Sleep Disorder Sleep Disturbance

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Pilot study in 3 nursing homes. The pilot phase (R61) informs the next phase (R33), a clinical trial using an incomplete, stepped, wedge cluster randomized controlled trial (RCT) design with 24 nursing homes. Each nursing home in the full clinical trial (R33) will act as its own control (4 staggered steps, with 6 nursing homes per step).

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

LOCK sleep intervention

Intervention Type BEHAVIORAL

Nursing home staff are trained to use a collaborative problem-solving approach to sleep quality improvement using front-line huddling

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

LOCK sleep intervention

Nursing home staff are trained to use a collaborative problem-solving approach to sleep quality improvement using front-line huddling

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No