Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Alzheimer Disease
  • Dementia
  • Sleep Disorder
  • Sleep Disturbance
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: pilot study in 3 nursing homes. The pilot phase will inform the next phase, a clinical trial using an incomplete, stepped, wedge cluster randomized controlled trial (RCT) design with 24 nursing homes. Each nursing home will act as its own control (6 staggered steps, with 4 nursing homes per step).Masking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 50 years and 125 years
Gender
Both males and females

Description

In community (non-VA) NHs [one from each of 3 NH corporations, still to be recruited], our multi-disciplinary team proposes to (1) refine the LOCK sleep program to focus on sleep for residents with ADRD during this pilot (R61) phase, (2) which will prepare the team for the next phase of this NIH-fun...

In community (non-VA) NHs [one from each of 3 NH corporations, still to be recruited], our multi-disciplinary team proposes to (1) refine the LOCK sleep program to focus on sleep for residents with ADRD during this pilot (R61) phase, (2) which will prepare the team for the next phase of this NIH-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 CURRENT PILOT STUDY R61 PHASE (1 YEAR; N = 3 NHS; 1 NH PER CORPORATION) HAS THE FOLLOWING SPECIFIC AIMS: Refine the LOCK sleep program train-the-trainer protocol by implementing and pilot-testing in three NHs. 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.

Tracking Information

NCT #
NCT04533815
Collaborators
  • University of Massachusetts, Lowell
  • The University of Texas Health Science Center, Houston
  • University of Texas at Austin
  • Brown University
Investigators
Not Provided