Alzheimer Disease40WinksNCT05820919
Enhancing Sleep Quality for Nursing Home Residents With Dementia - R33 Phase
A study testing LOCK Sleep Program in people with Alzheimer Disease and Dementia, run by University of Alabama, Tuscaloosa at 3 sites in United States.
Trial summary
This study seeks to improve clinical outcomes for an important, growing, and vulnerable population-nursing home residents with Alzheimer's disease or related dementias-by testing an evidence-based intervention to improve these residents' sleep. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer Disease, Dementia, Sleep Disorder
- What is being tested?
- LOCK Sleep Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 456 participants
- Where
- 3 sitesUnited States
- Study dates
- 7 Sep 2023to 29 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Vivage/Beecan Corporation
Lakewood, Colorado, 80228
Hope Carwile, MSW, 720-217-9043, hcarwile@vivagebeecan.com
- Recruiting
National HealthCare Corporation
Murfreesboro, Tennessee, 37130
Vicki Dodson, RN, vdodson@nhccare.com
Angela Westergard, LPN, 615-631-6146, angela.westergard@nhccare.com
- Recruiting
Caraday Healthcare, LLC
San Marcos, Texas, 78666
Paul Gerharter, RN,C, 512-641-8805, pgerharter@caradayhealth.com
Catherine McGuire, RN,MPAff, cmcguire@caradayhealth.com
About this study
Official title: Enhancing Sleep Quality for Nursing Home Residents With Dementia: Pragmatic Trial of an Evidence-Based Frontline Huddling Program
This study seeks to improve clinical outcomes for an important, growing, and vulnerable population-nursing home residents with Alzheimer's disease or related dementias-by testing an evidence-based intervention to improve these residents' sleep. It will also examine the implementation and sustainment of this intervention.
Read the detailed description
Disturbed sleep places older adults at higher risk for frailty, morbidity, and even mortality. Yet nursing home (NH) routines frequently disturb residents' sleep through use of noise and light or efforts, for example, to reduce incontinence. NH residents with Alzheimer's disease or related dementias-almost two-thirds of long-stay NH residents-are likely to be particularly affected by sleep disturbance. This study tackles these important issues and substantially moves forward goals of the National Plan to Address Alzheimer's Disease 2018 Update by proposing to implement an evidence-based intervention to improve sleep: a NH frontline staff huddling program known as LOCK. The LOCK program is derived from evidence supporting strengths-based learning, systematic observation, relationship-based teamwork, and efficiency.
This is an incomplete stepped-wedge randomized controlled trial to test the impact and sustainability of the LOCK sleep program. In 24 community nursing homes (NHs)-eight from each of 3 national NH corporations-our multi-disciplinary team will examine these aims: (1) Implement the LOCK-based sleep program for residents with ADRD using the train-the-trainer model. (2) Estimate impact of the LOCK sleep program on sleep (primary outcome) and on psychotropic medication use, pain and analgesic medication use, and activities of daily living decline (secondary outcomes). (3) Examine factors, using mixed methods, associated with variation in the program's implementation and its sustainability.
- Conditions
- Alzheimer Disease, Dementia, Sleep Disorder, Sleep Disturbance
- Being tested
- LOCK Sleep Program, No intervention (control period/baseline data collection)
- Medical subject headings
- Alzheimer Disease, Dementia, Sleep Wake Disorders, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LOCK Sleep ProgramBehavioural
The LOCK sleep program is a program that trains NH staff in a NH frontline staff huddling approach. It is derived from evidence supporting strengths-based learning, systematic observation, relationship-based teamwork, and efficiency. Staff learn how to work together as a team to collaboratively problem-solving about resident sleep challenges (e.g., evidence-based sleep promoting best practices and daytime meaningful activity best practices).
No intervention (control period/baseline data collection)Other
Each NH serves as its own control. During the control period, baseline data will be collected.
| Study group | Role | What they receive |
|---|---|---|
| Control (each NH acts as its own control): | Other | Each nursing home serves as its own control. Control data will be collected for 1 week (then the intervention will begin). Receives: Other: No intervention (control period/baseline data collection) |
| Intervention (all NHs receive the intervention): | Experimental | The intervention arm includes a ten-week active intervention phase, then a five-week sustainment phase. Receives: Behavioral: LOCK Sleep Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep (actigraph measurement)
Total sleep time (total minutes asleep each nighttime period - 10pm to 7am)
Measured: 15 week sleep intervention period
Secondary outcomes (5)
Psychotropic medication use
As recorded in the Minimum Data Set's Medications received subscale, Antipsychotic medication question, and Psychotropic Drug Care Area Trigger Code. The Medications received subscale asks if the resident has received any antipsychotic, antianxiety or antidepressant medication in the past seven days or since admission/reentry if less than seven days. The Antipsychotic medication, similar to in the previous subscale, asks whether the resident received antipsychotic medications since admission/entry or reentry or the prior OBRA assessment, whichever is more recent. Finally, the Psychotropic Drug Trigger Code asks whether the Psychotropic Drug Use Care Area was triggered. These are MDS items N0410A-C, N0450A, and V0200A17A, respectively. These data will be consolidated into a trichotomous indicator of change from baseline (decrease, increase, same).
Measured: 15 week sleep intervention period
Pain treatment received
Based on the Pain Management items as recorded in the Minimum Data Set. The Pain Management sub scale asks, using yes or no questions, if the resident has been on a scheduled pain medication regimen, received PRN pain medication or was offered and declined, and, has received non-medication intervention for pain in the past five days. These data will be consolidated into a trichotomous indicator of change from baseline (decrease, increase, same).
Measured: 15 week sleep intervention period
Pain - Resident Report
Based on the Pain Assessment items as recorded in the Minimum Data Set. The Pain Assessment sub scale asks if the resident has had pain or hurting (yes, no), the frequency of pain or hurting (almost constantly, frequently, occasionally, rarely), if the resident had difficulty sleeping because of pain or hurting (yes, no), if the residents day-to-day activities were limited because of pain or hurting (yes, no) over the past five days. The Pain Intensity sub scale asks the residents numeric pain rating value (0-10 scale) and intensity of worst pain experienced (mild, moderate, severe, very severe or horrible) in the past five days. These data will be consolidated into a trichotomous indicator of change from baseline (decrease, increase, same).
Measured: 15 week sleep intervention period
Pain - Staff Report
As recorded in the Minimum Data Set, the Staff Assessment sub scale asks staff members, all yes, no responses, if the resident had non-verbal sounds, verbal complaints, facial expressions, protective body movements or postures, or no signs that may be an indicator of possible pain in the last five days. These data will be consolidated into a trichotomous indicator of change from baseline (decrease, increase, same).
Measured: 15 week sleep intervention period
Activities of daily living decline
Has activities of daily living functional ability declined from baseline. Based on Minimum Data Set items assessing decline in activities of daily living (MDS; G0110A-J \& G0120A-B; QM N028.01), these data will be consolidated into a trichotomous indicator of change from baseline (decrease, increase, same)
Measured: 15 week sleep intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start7 Sep 2023
- Primary completion1 Apr 2026 (estimated)
- Study completion29 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- This is a wedge- based cluster randomized, controlled trial (RCT) design with each NH acting as its own control. The unit of random assignment is the NH. There are 24 NHs - 8 from each of 3 corporations. Each NH serves as its own control. Control data are collected for 1 week, then the intervention will begin with intervention data collected for 15 weeks (10-week active intervention period, and five-week sustainment period). All NHs are assigned to the control group and then phased into the intervention group at 37-week intervals (steps). Our stepped wedge design has 4 steps with 6 NHs per step (2 NHs per corporation per step). We will randomly assign the order in which the 8 NHs within each corporation are phased into the intervention group. We will randomize NHs within corporations to steps after matching on bed size and number of long-stay residents with ADRD diagnoses.
- Masking
- None (open label)
- Enrolment
- 456 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama, Tuscaloosa
- Sponsor type
- University, hospital or other
- Collaborators
- University of Massachusetts, Lowell, The University of Texas Health Science Center, Houston, University of Texas at Austin, Brown University
- Responsible party
- Principal investigator, A. Lynn Snow, University of Alabama, Tuscaloosa
- Investigators
- Lynn Snow, PhD, Principal investigator, The University of Alabama
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05820919
- Sponsor's protocol ID
- R33AG065619
- Acronym
- 40Winks
- Status last verified
- Mar 2024
- First submitted
- 7 Apr 2023
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share de-identified participant data by depositing data files and associated code books and analysis files with the data repository dataverse (dataverse.org). We will follow the University of Alabama IRB guidance and approval for ensuring that our data is appropriately de-identified before posting to dataverse. Our IRB-approved informed consent and HIPPAA forms seek participant permission for broad inclusion of participant data for these data sharing and secondary analysis purposes. We do not have authority to share Minimum Data Set (MDS) data, so we cannot deposit these data directly. However, we will share our analysis files and instructions on how to work with the federal owners of these data to request access; in this way other researchers will be able to replicate our steps in constructing the MDS data sets once they obtain the data from the federal owners (who do provide the data to the public via a standardized credentialed request process for a fee).
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Sleep Quality for Nursing Home Residents With Dementia: Pragmatic Trial of an Evidence-Based Frontline Huddling Program
- ClinicalTrials.gov ID
- NCT05820919
- Acronym / sponsor ID
- 40Winks / R33AG065619
- Conditions
- Alzheimer Disease, Dementia, Sleep Disorder, Sleep Disturbance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 456 participants (estimated)
- Lead sponsor
- University of Alabama, TuscaloosaUniversity, hospital or other
- Collaborators
- University of Massachusetts, Lowell, The University of Texas Health Science Center, Houston, University of Texas at Austin, Brown University
- Study start
- 7 Sep 2023 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 29 May 2027 (estimated)
- First posted
- 20 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study seeks to improve clinical outcomes for an important, growing, and vulnerable population-nursing home residents with Alzheimer's disease or related dementias-by testing an evidence-based intervention to improve these residents' sleep. It will also examine the implementation and sustainment of this intervention.
Detailed description
Disturbed sleep places older adults at higher risk for frailty, morbidity, and even mortality. Yet nursing home (NH) routines frequently disturb residents' sleep through use of noise and light or efforts, for example, to reduce incontinence. NH residents with Alzheimer's disease or related dementias-almost two-thirds of long-stay NH residents-are likely to be particularly affected by sleep disturbance. This study tackles these important issues and substantially moves forward goals of the National Plan to Address Alzheimer's Disease 2018 Update by proposing to implement an evidence-based intervention to improve sleep: a NH frontline staff huddling program known as LOCK. The LOCK program is derived from evidence supporting strengths-based learning, systematic observation, relationship-based teamwork, and efficiency.
This is an incomplete stepped-wedge randomized controlled trial to test the impact and sustainability of the LOCK sleep program. In 24 community nursing homes (NHs)-eight from each of 3 national NH corporations-our multi-disciplinary team will examine these aims: (1) Implement the LOCK-based sleep program for residents with ADRD using the train-the-trainer model. (2) Estimate impact of the LOCK sleep program on sleep (primary outcome) and on psychotropic medication use, pain and analgesic medication use, and activities of daily living decline (secondary outcomes). (3) Examine factors, using mixed methods, associated with variation in the program's implementation and its sustainability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a wedge- based cluster randomized, controlled trial (RCT) design with each NH acting as its own control. The unit of random assignment is the NH. There are 24 NHs - 8 from each of 3 corporations. Each NH serves as its own control. Control data are collected for 1 week, then the intervention will begin with intervention data collected for 15 weeks (10-week active intervention period, and five-week sustainment period). All NHs are assigned to the control group and then phased into the intervention group at 37-week intervals (steps). Our stepped wedge design has 4 steps with 6 NHs per step (2 NHs per corporation per step). We will randomly assign the order in which the 8 NHs within each corporation are phased into the intervention group. We will randomize NHs within corporations to steps after matching on bed size and number of long-stay residents with ADRD diagnoses.
| Arm | Type | Receives |
|---|---|---|
| Control (each NH acts as its own control): | Other | Other: No intervention (control period/baseline data collection)Each nursing home serves as its own control. Control data will be collected for 1 week (then the intervention will begin). |
| Intervention (all NHs receive the intervention): | Experimental | Behavioral: LOCK Sleep ProgramThe intervention arm includes a ten-week active intervention phase, then a five-week sustainment phase. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LOCK Sleep ProgramThe LOCK sleep program is a program that trains NH staff in a NH frontline staff huddling approach. It is derived from evidence supporting strengths-based learning, systematic observation, relationship-based teamwork, and efficiency. Staff learn how to work together as a team to collaboratively problem-solving about resident sleep challenges (e.g., evidence-based sleep promoting best practices and daytime meaningful activity best practices). | Behavioural | Intervention (all NHs receive the intervention): |
| No intervention (control period/baseline data collection)Each NH serves as its own control. During the control period, baseline data will be collected. | Other | Control (each NH acts as its own control): |
Primary outcome
Sleep (actigraph measurement)
Time frame: 15 week sleep intervention period
Total sleep time (total minutes asleep each nighttime period - 10pm to 7am)
5 secondary outcomes
Psychotropic medication use
Time frame: 15 week sleep intervention period
Pain treatment received
Time frame: 15 week sleep intervention period
Pain - Resident Report
Time frame: 15 week sleep intervention period
Pain - Staff Report
Time frame: 15 week sleep intervention period
Activities of daily living decline
Time frame: 15 week sleep intervention period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: Yes. We will share de-identified participant data by depositing data files and associated code books and analysis files with the data repository dataverse (dataverse.org). We will follow the University of Alabama IRB guidance and approval for ensuring that our data is appropriately de-identified before posting to dataverse. Our IRB-approved informed consent and HIPPAA forms seek participant permission for broad inclusion of participant data for these data sharing and secondary analysis purposes. We do not have authority to share Minimum Data Set (MDS) data, so we cannot deposit these data directly. However, we will share our analysis files and instructions on how to work with the federal owners of these data to request access; in this way other researchers will be able to replicate our steps in constructing the MDS data sets once they obtain the data from the federal owners (who do provide the data to the public via a standardized credentialed request process for a fee).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lynn Snow, PhD principal investigator
The University of Alabama
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LOCK Sleep Program in people with Alzheimer Disease and Dementia, run by University of Alabama, Tuscaloosa at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lynn Snow, PhD (205-201-0312, LSNOW@ua.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep (actigraph measurement) (time frame: 15 week sleep intervention period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.