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| Name | Class |
|---|---|
| University of Massachusetts, Lowell | OTHER |
| The University of Texas Health Science Center, Houston | OTHER |
| University of Texas at Austin | OTHER |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LOCK sleep intervention | Experimental | Nursing home staff receive the LOCK sleep intervention training and thus provide to nursing home residents with dementia the LOCK sleep intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LOCK sleep intervention | Behavioral | Nursing home staff are trained to use a collaborative problem-solving approach to sleep quality improvement using front-line huddling |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sleep (Actigraph Measurement) | Total sleep time (total minutes asleep each nighttime period - 7pm to 7am) | 15 week sleep intervention period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lynn Snow, PhD | The University of Alabama | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Alabama | Tuscaloosa | Alabama | 35487-0348 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33906631 | Background | 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. |
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The research team will share de-identified participant data by depositing data files and associated code books and analysis files with the data repository dataverse (dataverse.org). The research team will follow the University of Alabama IRB guidance and approval for ensuring that the data is appropriately de-identified before posting to dataverse. The IRB-approved informed consent and HIPPAA forms seek participant permission for broad inclusion of participant data for these data sharing and secondary analysis purposes.
Within 6 months of study closure, for 5 years
Under development. Contact PI.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sleep (Actigraph Measurement) | Total sleep time (total minutes asleep each nighttime period - 7pm to 7am) | Enrollees completing the 15-week intervention period | Posted | Mean | Standard Deviation | Nighttime sleep minutes | 15 week sleep intervention period |
|
|
During the active 15-week intervention period for each enrolled resident.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Did not tolerate wearing actiwatch | Social circumstances | Systematic Assessment | Participant found watch uncomfortable and communicated desire to have watch removed (either through words or nonverbally by repeatedly pulling at watch) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lynn Snow | University of Alabama | 205-201-0312 | LSNOW@ua.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 14, 2022 | Dec 19, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| D012893 | Sleep Wake Disorders |
| D020447 | Parasomnias |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
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| Brown University |
| OTHER |
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).
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| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Nighttime sleep minutes (actiwatch measurement) | Mean | Standard Deviation | Nighttime Sleep Minutes |
|
| Participants |
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| 2 |
| 23 |
|
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| D019636 |
| Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |