Trial Outcomes & Findings for Improving Sleep Using Mentored Behavioral and Environmental Restructuring (NCT NCT03327324)
NCT ID: NCT03327324
Last Updated: 2023-02-08
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
110 participants
Primary outcome timeframe
Baseline
Results posted on
2023-02-08
Participant Flow
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.
Participant milestones
| Measure |
F1U1
Sequence 1 (Facility 1/Unit 1): Baseline, then 3 Month SLUMBER Intervention, then 39 Month Sustainability.
|
F1U2
Sequence 2 (Facility 1/Unit 2): Baseline, then 3 Month SLUMBER Intervention, then 33 Month Sustainability
|
F2U2
Sequence 3 (Facility 2/Unit 2): Baseline, then 3 Month SLUMBER Intervention, then 27 Month Sustainability
|
F2U3
Sequence 4 (Facility 2/Unit 3): Baseline, then 3 Month SLUMBER Intervention, then 21 Month Sustainability
|
F2U4
Sequence 5 (Facility 2/Unit 4): Baseline, then 3 Month SLUMBER Intervention, then 15 Month Sustainability
|
F3U1
Sequence 6 (Facility 3/Unit 1): Baseline, then 3 Month SLUMBER Intervention, then 9 Month Sustainability
|
|---|---|---|---|---|---|---|
|
Baseline (Month 0-Month 3)
STARTED
|
18
|
20
|
9
|
10
|
15
|
20
|
|
Baseline (Month 0-Month 3)
COMPLETED
|
18
|
17
|
9
|
9
|
13
|
14
|
|
Baseline (Month 0-Month 3)
NOT COMPLETED
|
0
|
3
|
0
|
1
|
2
|
6
|
|
Intervention (Month 3-Month 6)
STARTED
|
18
|
17
|
9
|
9
|
13
|
14
|
|
Intervention (Month 3-Month 6)
COMPLETED
|
13
|
16
|
6
|
8
|
11
|
0
|
|
Intervention (Month 3-Month 6)
NOT COMPLETED
|
5
|
1
|
3
|
1
|
2
|
14
|
|
Sustainability Follow-Up 1 (Month 6-9)
STARTED
|
13
|
16
|
6
|
8
|
11
|
0
|
|
Sustainability Follow-Up 1 (Month 6-9)
COMPLETED
|
9
|
14
|
5
|
5
|
6
|
0
|
|
Sustainability Follow-Up 1 (Month 6-9)
NOT COMPLETED
|
4
|
2
|
1
|
3
|
5
|
0
|
|
Sustainability Follow-Up 2 (Month 9-12)
STARTED
|
9
|
14
|
2
|
0
|
0
|
0
|
|
Sustainability Follow-Up 2 (Month 9-12)
COMPLETED
|
7
|
14
|
2
|
0
|
0
|
0
|
|
Sustainability Follow-Up 2 (Month 9-12)
NOT COMPLETED
|
2
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
F1U1
Sequence 1 (Facility 1/Unit 1): Baseline, then 3 Month SLUMBER Intervention, then 39 Month Sustainability.
|
F1U2
Sequence 2 (Facility 1/Unit 2): Baseline, then 3 Month SLUMBER Intervention, then 33 Month Sustainability
|
F2U2
Sequence 3 (Facility 2/Unit 2): Baseline, then 3 Month SLUMBER Intervention, then 27 Month Sustainability
|
F2U3
Sequence 4 (Facility 2/Unit 3): Baseline, then 3 Month SLUMBER Intervention, then 21 Month Sustainability
|
F2U4
Sequence 5 (Facility 2/Unit 4): Baseline, then 3 Month SLUMBER Intervention, then 15 Month Sustainability
|
F3U1
Sequence 6 (Facility 3/Unit 1): Baseline, then 3 Month SLUMBER Intervention, then 9 Month Sustainability
|
|---|---|---|---|---|---|---|
|
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
|
|
Baseline (Month 0-Month 3)
Death
|
0
|
0
|
0
|
0
|
1
|
0
|
|
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
|
|
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)
Withdrawal by Subject
|
2
|
1
|
1
|
0
|
1
|
0
|
|
Intervention (Month 3-Month 6)
Left Nursing Home Facility
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Intervention (Month 3-Month 6)
Death
|
1
|
0
|
1
|
1
|
1
|
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
|
|
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 1 (Month 6-9)
Death
|
1
|
1
|
1
|
0
|
0
|
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 2 (Month 9-12)
Left Nursing Home
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Sustainability Follow-Up 2 (Month 9-12)
Death
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Improving Sleep Using Mentored Behavioral and Environmental Restructuring
Baseline characteristics by cohort
| Measure |
F1U1
n=18 Participants
Sequence 1 (Facility 1/Unit 1): Baseline, then 3 Month SLUMBER Intervention, then 39 Month Sustainability
|
F1U2
n=17 Participants
Sequence 2: (Facility 1/Unit 2): Baseline, then 3 Month SLUMBER Intervention, then 33 Month Sustainability
|
F2U2
n=9 Participants
Sequence 3 (Facility 2/Unit 2): Baseline, then 3 Month SLUMBER Intervention, then 27 Month Sustainability
|
F2U3
n=9 Participants
Sequence 4 (Facility 2/Unit 3): Baseline, then 3 Month SLUMBER Intervention, then 21 Month Sustainability
|
F2U4
n=13 Participants
Sequence 5 (Facility 2/Unit 4): Baseline, then 3 Month SLUMBER Intervention, then 15 Month Sustainability
|
F3U1
n=14 Participants
Sequence 6 (Facility 3/Unit 1): Baseline, then 3 Month SLUMBER Intervention, then 9 Month Sustainability
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
66 years
STANDARD_DEVIATION 8 • n=5 Participants
|
66 years
STANDARD_DEVIATION 8 • n=7 Participants
|
89 years
STANDARD_DEVIATION 7 • n=5 Participants
|
92 years
STANDARD_DEVIATION 8 • n=4 Participants
|
91 years
STANDARD_DEVIATION 5 • n=21 Participants
|
75 years
STANDARD_DEVIATION 11 • n=10 Participants
|
81 years
STANDARD_DEVIATION 14 • n=115 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
11 Participants
n=10 Participants
|
52 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
28 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
17 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
12 Participants
n=10 Participants
|
63 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
26 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
35 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
17 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
17 participants
n=7 Participants
|
9 participants
n=5 Participants
|
9 participants
n=4 Participants
|
13 participants
n=21 Participants
|
14 participants
n=10 Participants
|
80 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: 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.
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.
Outcome measures
| Measure |
Resident of the Skilled Nursing Facility
n=52 Participants
Sleep 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.
|
|---|---|
|
Sleep Efficiency (SE)
|
76.1 percentage of time in bed
Interval 71.83 to 80.38
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Resident of the Skilled Nursing Facility
n=52 Participants
Sleep 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.
|
|---|---|
|
Sleep Efficiency (SE)
|
75.69 percentage of time in bed
Interval 70.89 to 80.49
|
PRIMARY outcome
Timeframe: Month 9 Post-BaselinePopulation: 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.
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.
Outcome measures
| Measure |
Resident of the Skilled Nursing Facility
n=52 Participants
Sleep 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.
|
|---|---|
|
Sleep Efficiency (SE)
|
75.61 percentage of time in bed
Interval 70.05 to 81.18
|
PRIMARY outcome
Timeframe: BaselinePopulation: 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.
Data will be obtained from antigraphy analysis.
Outcome measures
| Measure |
Resident of the Skilled Nursing Facility
n=52 Participants
Sleep 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.
|
|---|---|
|
Nighttime Total Awake Time
|
11.54 Minutes
Interval 9.92 to 13.15
|
PRIMARY outcome
Timeframe: Post-Treatment (Month 6 Post-Baseline)Data will be obtained from antigraphy analysis.
Outcome measures
| Measure |
Resident of the Skilled Nursing Facility
n=52 Participants
Sleep 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.
|
|---|---|
|
Nighttime Total Awake Time
|
11.03 Minutes
Interval 9.22 to 12.84
|
PRIMARY outcome
Timeframe: Month 9 Post-BaselinePopulation: 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.
Data will be obtained from antigraphy analysis.
Outcome measures
| Measure |
Resident of the Skilled Nursing Facility
n=52 Participants
Sleep 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.
|
|---|---|
|
Nighttime Total Awake Time
|
11.8 Minutes
Interval 9.29 to 14.31
|
PRIMARY outcome
Timeframe: BaselinePopulation: 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.
Wrist device / actigraphy will be used to measure sleep/wake time.
Outcome measures
| Measure |
Resident of the Skilled Nursing Facility
n=52 Participants
Sleep 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.
|
|---|---|
|
Daytime Sleeping (Napping) Time
|
305.91 Minutes
Interval 261.63 to 350.18
|
PRIMARY outcome
Timeframe: 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.
Wrist device / actigraphy will be used to measure sleep/wake time.
Outcome measures
| Measure |
Resident of the Skilled Nursing Facility
n=52 Participants
Sleep 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.
|
|---|---|
|
Daytime Sleeping (Napping) Time
|
369.7 Minutes
Interval 314.92 to 424.47
|
PRIMARY outcome
Timeframe: Month 9 Post-BaselinePopulation: 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.
Wrist device / actigraphy will be used to measure sleep/wake time.
Outcome measures
| Measure |
Resident of the Skilled Nursing Facility
n=52 Participants
Sleep 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.
|
|---|---|
|
Daytime Sleeping (Napping) Time
|
338.26 Minutes
Interval 287.79 to 388.73
|
PRIMARY outcome
Timeframe: Month 9 Post-BaselinePSQI 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.
Outcome measures
| Measure |
Resident of the Skilled Nursing Facility
n=56 Participants
Sleep 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.
|
|---|---|
|
Score on Pittsburgh Sleep Quality Index (PSQI)
|
6.5 score on a scale
Interval 5.54 to 7.52
|
PRIMARY outcome
Timeframe: Month 9 Post-BaselineBADS 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
Outcome measures
| Measure |
Resident of the Skilled Nursing Facility
n=56 Participants
Sleep 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.
|
|---|---|
|
Brief Anxiety and Depression Scale (BADS) Questionnaire Score
|
5.15 score on a scale
Interval 3.74 to 6.55
|
PRIMARY outcome
Timeframe: Month 9 Post-BaselineBCAT 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.
Outcome measures
| Measure |
Resident of the Skilled Nursing Facility
n=56 Participants
Sleep 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.
|
|---|---|
|
Score on Brief Cognitive Assessment Tool (BCAT)
|
28.33 score on a scale
Interval 25.42 to 31.23
|
Adverse Events
Resident of the Skilled Nursing Facility
Serious events: 0 serious events
Other events: 0 other events
Deaths: 9 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place