Clinical trial NCT04533815: Enhancing Sleep Quality for Nursing Home Residents With Dementia
Official title: Enhancing Sleep Quality for Nursing Home Residents With Dementia: Pragmatic Trial of an Evidence-Based Frontline Huddling Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Dementia
Sleep Disorder
Sleep Disturbance
Lead sponsor: University of Alabama, Tuscaloosa
Sponsor class: OTHER
Collaborators: name: University of Massachusetts, Lowell
name: The University of Texas Health Science Center, Houston
name: University of Texas at Austin
name: Brown University
First posted: 2020-09-01
Enrollment: 23
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Sleep (Actigraph Measurement)
timeFrame: 15 week sleep intervention period
Secondary outcomes:
Other outcomes:
Locations:
city: Tuscaloosa
country: United States
facility: The University of Alabama
state: Alabama
Study officials:
affiliation: The University of Alabama
name: Lynn Snow, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Snow AL, Loup J, Morgan RO, Richards K, Parmelee PA, Baier RR, McCreedy E, Frank B, Brady C, Fry L, McCullough M, Hartmann CW. Enhancing sleep quality for nursing home residents with dementia: a pragmatic randomized controlled trial of an evidence-based frontline huddling program. BMC Geriatr. 2021 Apr 27;21(1):281. doi: 10.1186/s12877-021-02189-8.