Alzheimer Disease, Dementia, Sleep Disorder, Sleep Disturbance
Conditions
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.
Interventions
BEHAVIORALLOCK sleep intervention
Nursing home staff are trained to use a collaborative problem-solving approach to sleep quality improvement using front-line huddling
Sponsors
University of Massachusetts, Lowell
The University of Texas Health Science Center, Houston
University of Texas at Austin
Brown University
University of Alabama, Tuscaloosa
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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).
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep (Actigraph Measurement) | 15 week sleep intervention period | Total sleep time (total minutes asleep each nighttime period - 7pm to 7am) |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from the three participating community nursing homes. Nursing home staff referred residents to the study that they identified as meeting eligibility criteria.
Participants by arm
| Arm | Count |
|---|---|
| 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
LOCK sleep intervention: Nursing home staff are trained to use a collaborative problem-solving approach to sleep quality improvement using front-line huddling | 23 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Site withdrew | 5 |
Baseline characteristics
| Characteristic | LOCK Sleep Intervention |
|---|---|
| Age, Continuous | 77.74 Years STANDARD_DEVIATION 12.18 |
| Nighttime sleep minutes (actiwatch measurement) | 520.00 Nighttime Sleep Minutes STANDARD_DEVIATION 113.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 19 Participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 23 |
| other Total, other adverse events | 2 / 23 |
| serious Total, serious adverse events | 0 / 23 |
Outcome results
Primary
Sleep (Actigraph Measurement)
Total sleep time (total minutes asleep each nighttime period - 7pm to 7am)
Time frame: 15 week sleep intervention period
Population: Enrollees completing the 15-week intervention period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LOCK Sleep Intervention | Sleep (Actigraph Measurement) | 544.00 Nighttime sleep minutes | Standard Deviation 113.97 |