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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

110

participants targeted

Target at P50-P75 for not_applicable

Timeline

Completed

Started Mar 2018

Typical duration for not_applicable

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.9 years study duration

First Submitted

Initial submission to the registry

October 25, 2017

Completed

6 days until next milestone

First Posted

Study publicly available on registry

October 31, 2017

Completed

5 months until next milestone

Study Start

First participant enrolled

March 27, 2018

Completed

2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2021

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2021

Completed

2 years until next milestone

Results Posted

Study results publicly available

February 8, 2023

Completed

Last Updated

February 8, 2023

Status Verified

January 1, 2023

Enrollment Period

2.9 years

First QC Date

October 25, 2017

Results QC Date

June 16, 2022

Last Update Submit

January 10, 2023

Conditions

Insomnia

Outcome Measures

Primary Outcomes (12)

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.
Baseline
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.
Post-Treatment (Month 6 Post-Baseline)
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.
Month 9 Post-Baseline
Nighttime Total Awake Time
Data will be obtained from antigraphy analysis.
Baseline
Nighttime Total Awake Time
Data will be obtained from antigraphy analysis.
Post-Treatment (Month 6 Post-Baseline)
Nighttime Total Awake Time
Data will be obtained from antigraphy analysis.
Month 9 Post-Baseline
Daytime Sleeping (Napping) Time
Wrist device / actigraphy will be used to measure sleep/wake time.
Baseline
Daytime Sleeping (Napping) Time
Wrist device / actigraphy will be used to measure sleep/wake time.
Post-Treatment (Month 6 Post-Baseline)
Daytime Sleeping (Napping) Time
Wrist device / actigraphy will be used to measure sleep/wake time.
Month 9 Post-Baseline
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.
Month 9 Post-Baseline
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
Month 9 Post-Baseline
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.
Month 9 Post-Baseline

Study Arms (6)

F1U1

EXPERIMENTAL

Sequence 1 (Facility 1/Unit 1): Baseline, then 3 Month SLUMBER Intervention, then 39 Month Sustainability.