Insomnia
Conditions
Brief summary
The goal of this study is to test potential functional/psychosocial benefits of improved sleep using a program designed to teach nursing facility staff to improve sleep promoting strategies and environment for nursing home residents. Sleep disturbances are quite common in skilled nursing facilities and affect as many as 69% of residents while staff do not fully understand how to improve sleep without using medications. Medications for sleep are commonly used as first-line therapy for older adults but this is problematic because these medications can lead to greater problems with thinking, more frequent falls, and even worse sleep over time. In addition, poor sleep can lead to depressed mood, greater trouble with thinking and memory, worse pain, and greater need for help with daily activities.
Detailed description
This is a study to test the effects of improved sleep quality on downstream functional/psychosocial outcomes.
Interventions
BEHAVIORALSleep Using Mentored Behavioral and Environmental Restructuring
SLUMBER is a non-pharmacological intervention program, delivered by providing mentoring to facility staff who work directly with residents. SLUMBER focuses on detecting sleep-disruptive factors including: nighttime noise and patient behaviors associated with poor sleep quality; disruptions caused by nighttime caregiving; daytime inactivity; and limited light exposure. In this model, staff-delivered interventions to improve these factors improve sleep quality thereby creating opportunities to test the impact of improving sleep quality (measured by actigraphy) on mood (depression and anxiety), pain, cognitive function, functional ability, and observed activity levels.
Sponsors
National Institutes of Health (NIH)
National Institute of Nursing Research (NINR)
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* living in the unit of intervention, * ability to communicate and follow simple commands, * English- or Spanish-speaking, * capacity to consent assessed with standard questions used to assess capacity or having a surrogate who can provide consent.
Exclusion criteria
* Does not have capacity and does not show enthusiasm for the research * Does not have capacity and does not have a proxy. * obtunded or comatose state, * inability to communicate verbally, * inability to consent and without surrogate * non-English and non-Spanish speaking. In keeping with QI strategies, all residents will be exposed to the environmental aspects of the intervention, as these strategies represent clinically proven non-experimental behavioral strategies with no perceptible harm.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Score on Pittsburgh Sleep Quality Index (PSQI) | Month 9 Post-Baseline | PSQI contains 19 self-rated questions. The 19 questions are combined to form seven component scores, each of which has a range of 0-3 points. In all cases, a score of 0 indicates no difficulty, while a score of 3 indicates severe difficulty. The total score range is 0-21; the higher the score, the greater the difficulties in all areas. |
| Brief Anxiety and Depression Scale (BADS) Questionnaire Score | Month 9 Post-Baseline | BADS is a brief screening tool for mood impairment developed for older adults. It consists of 8 questions, answered 0 (no), 1(somewhat), or 2 (yes). The total score range is 0-16; the higher the score, the higher the level of mood impairment |
| Sleep Efficiency (SE) | Baseline | Sleep efficiency (SE), commonly defined as the ratio of total sleep time (TST) to time in bed (TIB), will be reported as a percentage of time in bed. This data will be obtained from actigraphy analysis. |
| Nighttime Total Awake Time | Baseline | Data will be obtained from antigraphy analysis. |
| Daytime Sleeping (Napping) Time | Baseline | Wrist device / actigraphy will be used to measure sleep/wake time. |
| Score on Brief Cognitive Assessment Tool (BCAT) | Month 9 Post-Baseline | BCAT is a multi-domain cognitive instrument that assesses orientation, verbal recall, visual recognition, visual recall, attention, abstraction, language, executive functions, and visuo-spatial processing in adult and older adult populations. It consists of 21 items. The total score range is 0-50; the higher the score, the more normal the level of cognitive functioning and independent living. |
Countries
United States
Participant flow
Pre-assignment details
This is a stepped wedge intervention trial (SWT). In this SWT, all units receive the intervention but at different time points. Every unit provides baseline and follow-up data.
Participants by arm
| Arm | Count |
|---|---|
| F1U1 Sequence 1 (Facility 1/Unit 1): Baseline, then 3 Month SLUMBER Intervention, then 39 Month Sustainability | 18 |
| F1U2 Sequence 2: (Facility 1/Unit 2): Baseline, then 3 Month SLUMBER Intervention, then 33 Month Sustainability | 17 |
| F2U2 Sequence 3 (Facility 2/Unit 2): Baseline, then 3 Month SLUMBER Intervention, then 27 Month Sustainability | 9 |
| F2U3 Sequence 4 (Facility 2/Unit 3): Baseline, then 3 Month SLUMBER Intervention, then 21 Month Sustainability | 9 |
| F2U4 Sequence 5 (Facility 2/Unit 4): Baseline, then 3 Month SLUMBER Intervention, then 15 Month Sustainability | 13 |
| F3U1 Sequence 6 (Facility 3/Unit 1): Baseline, then 3 Month SLUMBER Intervention, then 9 Month Sustainability | 14 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Baseline (Month 0-Month 3) | COVID-Incomplete (couldn't collect all subject data due to Nursing Home COVID shutdown) | 0 | 0 | 0 | 0 | 0 | 1 |
| Baseline (Month 0-Month 3) | Death | 0 | 0 | 0 | 0 | 1 | 0 |
| Baseline (Month 0-Month 3) | Incomplete (participant did not complete all data items collected during study visit) | 0 | 1 | 0 | 1 | 0 | 5 |
| Baseline (Month 0-Month 3) | Refused | 0 | 0 | 0 | 0 | 1 | 0 |
| Baseline (Month 0-Month 3) | Withdrawal by Subject | 0 | 2 | 0 | 0 | 0 | 0 |
| Intervention (Month 3-Month 6) | COVID-Incomplete (couldn't collect all subject data due to Nursing Home COVID shutdown) | 0 | 0 | 0 | 0 | 0 | 14 |
| Intervention (Month 3-Month 6) | Death | 1 | 0 | 1 | 1 | 1 | 0 |
| Intervention (Month 3-Month 6) | Incomplete (participant did not complete all data items collected during study visit) | 0 | 0 | 1 | 0 | 0 | 0 |
| Intervention (Month 3-Month 6) | Left Nursing Home Facility | 2 | 0 | 0 | 0 | 0 | 0 |
| Intervention (Month 3-Month 6) | Withdrawal by Subject | 2 | 1 | 1 | 0 | 1 | 0 |
| Sustainability Follow-Up 1 (Month 6-9) | COVID-Incomplete (couldn't collect all subject data due to Nursing Home COVID shutdown) | 0 | 0 | 0 | 3 | 5 | 0 |
| Sustainability Follow-Up 1 (Month 6-9) | Death | 1 | 1 | 1 | 0 | 0 | 0 |
| Sustainability Follow-Up 1 (Month 6-9) | Incomplete (participant did not complete all data items collected during study visit) | 1 | 0 | 0 | 0 | 0 | 0 |
| Sustainability Follow-Up 1 (Month 6-9) | Left Nursing Home Facility | 2 | 1 | 0 | 0 | 0 | 0 |
| Sustainability Follow-Up 2 (Month 9-12) | Death | 1 | 0 | 0 | 0 | 0 | 0 |
| Sustainability Follow-Up 2 (Month 9-12) | Left Nursing Home | 1 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | F1U1 | Total | F3U1 | F2U4 | F2U3 | F2U2 | F1U2 |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 66 years STANDARD_DEVIATION 8 | 81 years STANDARD_DEVIATION 14 | 75 years STANDARD_DEVIATION 11 | 91 years STANDARD_DEVIATION 5 | 92 years STANDARD_DEVIATION 8 | 89 years STANDARD_DEVIATION 7 | 66 years STANDARD_DEVIATION 8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 17 Participants | 2 Participants | 2 Participants | 0 Participants | 2 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants | 63 Participants | 12 Participants | 11 Participants | 9 Participants | 7 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants | 26 Participants | 3 Participants | 1 Participants | 0 Participants | 0 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 17 Participants | 2 Participants | 2 Participants | 0 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) White | 0 Participants | 35 Participants | 9 Participants | 10 Participants | 7 Participants | 7 Participants | 2 Participants |
| Region of Enrollment United States | 18 participants | 80 participants | 14 participants | 13 participants | 9 participants | 9 participants | 17 participants |
| Sex: Female, Male Female | 9 Participants | 52 Participants | 11 Participants | 9 Participants | 8 Participants | 4 Participants | 11 Participants |
| Sex: Female, Male Male | 9 Participants | 28 Participants | 3 Participants | 4 Participants | 1 Participants | 5 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 9 / 110 |
| other Total, other adverse events | 0 / 110 |
| serious Total, serious adverse events | 0 / 110 |
Outcome results
Primary
Brief Anxiety and Depression Scale (BADS) Questionnaire Score
BADS is a brief screening tool for mood impairment developed for older adults. It consists of 8 questions, answered 0 (no), 1(somewhat), or 2 (yes). The total score range is 0-16; the higher the score, the higher the level of mood impairment
Time frame: Month 9 Post-Baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Resident of the Skilled Nursing Facility | Brief Anxiety and Depression Scale (BADS) Questionnaire Score | 5.15 score on a scale |
Primary
Daytime Sleeping (Napping) Time
Wrist device / actigraphy will be used to measure sleep/wake time.
Time frame: Month 9 Post-Baseline
Population: Sleep/wake time was measured using wrist actigraphs and some participants took off the watch, meaning some participants were not included in the analysis of this outcome measure.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Resident of the Skilled Nursing Facility | Daytime Sleeping (Napping) Time | 338.26 Minutes |
Primary
Daytime Sleeping (Napping) Time
Wrist device / actigraphy will be used to measure sleep/wake time.
Time frame: Post-Treatment (Month 6 Post-Baseline)
Population: Sleep/wake time was measured using wrist actigraphs and some participants took off the watch, meaning some participants were not included in the analysis of this outcome measure.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Resident of the Skilled Nursing Facility | Daytime Sleeping (Napping) Time | 369.7 Minutes |
Primary
Daytime Sleeping (Napping) Time
Wrist device / actigraphy will be used to measure sleep/wake time.
Time frame: Baseline
Population: Sleep/wake time was measured using wrist actigraphs and some participants took off the watch, meaning some participants were not included in the analysis of this outcome measure.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Resident of the Skilled Nursing Facility | Daytime Sleeping (Napping) Time | 305.91 Minutes |
Primary
Nighttime Total Awake Time
Data will be obtained from antigraphy analysis.
Time frame: Month 9 Post-Baseline
Population: Sleep/wake time was measured using wrist actigraphs and some participants took off the watch, meaning some participants were not included in the analysis of this outcome measure.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Resident of the Skilled Nursing Facility | Nighttime Total Awake Time | 11.8 Minutes |
Primary
Nighttime Total Awake Time
Data will be obtained from antigraphy analysis.
Time frame: Baseline
Population: Sleep/wake time was measured using wrist actigraphs and some participants took off the watch, meaning some participants were not included in the analysis of this outcome measure.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Resident of the Skilled Nursing Facility | Nighttime Total Awake Time | 11.54 Minutes |
Primary
Nighttime Total Awake Time
Data will be obtained from antigraphy analysis.
Time frame: Post-Treatment (Month 6 Post-Baseline)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Resident of the Skilled Nursing Facility | Nighttime Total Awake Time | 11.03 Minutes |
Primary
Score on Brief Cognitive Assessment Tool (BCAT)
BCAT is a multi-domain cognitive instrument that assesses orientation, verbal recall, visual recognition, visual recall, attention, abstraction, language, executive functions, and visuo-spatial processing in adult and older adult populations. It consists of 21 items. The total score range is 0-50; the higher the score, the more normal the level of cognitive functioning and independent living.
Time frame: Month 9 Post-Baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Resident of the Skilled Nursing Facility | Score on Brief Cognitive Assessment Tool (BCAT) | 28.33 score on a scale |
Primary
Score on Pittsburgh Sleep Quality Index (PSQI)
PSQI contains 19 self-rated questions. The 19 questions are combined to form seven component scores, each of which has a range of 0-3 points. In all cases, a score of 0 indicates no difficulty, while a score of 3 indicates severe difficulty. The total score range is 0-21; the higher the score, the greater the difficulties in all areas.
Time frame: Month 9 Post-Baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Resident of the Skilled Nursing Facility | Score on Pittsburgh Sleep Quality Index (PSQI) | 6.5 score on a scale |
Primary
Sleep Efficiency (SE)
Sleep efficiency (SE), commonly defined as the ratio of total sleep time (TST) to time in bed (TIB), will be reported as a percentage of time in bed. This data will be obtained from actigraphy analysis.
Time frame: Month 9 Post-Baseline
Population: Sleep/wake time was measured using wrist actigraphs and some participants took off the watch, meaning some participants were not included in the analysis of this outcome measure.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Resident of the Skilled Nursing Facility | Sleep Efficiency (SE) | 75.61 percentage of time in bed |
Primary
Sleep Efficiency (SE)
Sleep efficiency (SE), commonly defined as the ratio of total sleep time (TST) to time in bed (TIB), will be reported as a percentage of time in bed. This data will be obtained from actigraphy analysis.
Time frame: Post-Treatment (Month 6 Post-Baseline)
Population: Sleep/wake time was measured using wrist actigraphs and some participants took off the watch, meaning some participants were not included in the analysis of this outcome measure.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Resident of the Skilled Nursing Facility | Sleep Efficiency (SE) | 75.69 percentage of time in bed |
Primary
Sleep Efficiency (SE)
Sleep efficiency (SE), commonly defined as the ratio of total sleep time (TST) to time in bed (TIB), will be reported as a percentage of time in bed. This data will be obtained from actigraphy analysis.
Time frame: Baseline
Population: Sleep/wake time was measured using wrist actigraphs and some participants took off the watch, meaning some participants were not included in the analysis of this outcome measure.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Resident of the Skilled Nursing Facility | Sleep Efficiency (SE) | 76.1 percentage of time in bed |