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| ID | Type | Description | Link |
|---|---|---|---|
| P20GM103443 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
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This will be a study looking at trying to change community-dwelling older adults' behavior in regard to good sleep hygiene practices. Investigators will assess the efficacy through subjective outcome measures and objective physiological markers of good sleep through data collected with wearable technology devices.
Community-dwelling older adults will be recruited and placed into one of two groups. Group one will watch a one-time educational video on sleep hygiene and group two will watch the video plus be sent daily automated text messages to reinforce the education learned in the video. The participants will receive the text messages for a total of 4 weeks. The control group will not receive any intervention during this time frame. Following the initial meeting, all participants will wear the sleep tracker on their wrists during the day and night for 4 weeks. The sleep tracker will monitor the physiological markers of sleep provided by wearable technology on sleep efficiency, time in bed, time actually sleeping, and time spent at each stage of sleep. At the end of the 4-week study period, the researchers will once again meet with each participant. The participant will complete the following questionnaires once again.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| One-time educational video | Experimental | A one-time educational video on best practices for good sleep hygiene |
|
| One-time educational video plus automated text messaging | Experimental | A one-time educational video on best practices for sleep hygiene plus daily automated text messages to reinforce habit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| One-time educational video | Behavioral | One-time educational video |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change Score From Baseline to 4-week Follow up on the Pittsburgh Sleep Quality Index | Outcome measure for quality of sleep. Score ranges 0-21 with higher score equaling poor sleep quality | Baseline and 4-week follow up |
| Change Score From Baseline to 4-week Follow up on the Sleep Hygiene Index | Outcome measure for good sleep hygiene. Scores range from 0-52. Higher scores equate to worse sleep hygiene. | Baseline and 4-week follow up |
| Change Score From Baseline to 4-week Follow up on the Numeric Pain Rating Scale | Outcome measure for average pain levels. Scores range from 0-10. Higher scores equate to higher pain levels. | Baseline and 4-week follow up |
| Change Score From Baseline to 4-week Follow up on the Epworth Sleepiness Scale | Outcome measure for average daytime sleepiness. Scores range from 0-24. Higher scores equate to worse daytime sleepiness. | Baseline and 4-week follow up |
| Change Score From Baseline to 4-weeks for Participants' Sleep Efficiency Using Wearable Technology. | Sleep efficiency scores will be calculated using a sleep tracker device and are defined as time spent in bed versus time spent actually sleeping. 85% or higher is considered normal sleep efficiency. The average sleep efficiency score for the first three days at baseline and average sleep efficiency from the last 3 days of the 4 week study period will be used to gather the change score. | Baseline, 4-week follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Change Score From Baseline to 4-week Follow up on the Perceived Stress Scale | Outcome measure for average stress levels. Scores range from 0-40. The higher the score the worse the stress levels. | Baseline and 4-week follow up |
| Change Score From Baseline to 4-week Follow up on the Patient Specific Functional Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ashley M Pfeiffer | Black Hills State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Black Hills State University | Spearfish | South Dakota | 57799 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | One-time Educational Video | A one-time educational video on best practices for good sleep hygiene One-time educational video: One-time educational video |
| FG001 | One-time Educational Video Plus Automated Text Messaging | A one-time educational video on best practices for sleep hygiene plus daily automated text messages to reinforce habit. One-time educational video plus automated text messaging: Educational video plus automated text messaging |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | One-time Educational Video | A one-time educational video on best practices for good sleep hygiene One-time educational video: One-time educational video |
| BG001 | One-time Educational Video Plus Automated Text Messaging |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Change Score From Baseline to 4-week Follow up on the Pittsburgh Sleep Quality Index | Outcome measure for quality of sleep. Score ranges 0-21 with higher score equaling poor sleep quality | Change score average | Posted | Mean | Full Range | units on a scale | Baseline and 4-week follow up |
|
Adverse events were monitored for the one-month of the study however no adverse events were reported.
The number of participants at risk for serious adverse events, all-cause mortality, and other is zero due to a minimal risk activity of filling out surveys and wearing a sleep tracker.
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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 | One-time Educational Video | A one-time educational video on best practices for good sleep hygiene One-time educational video: One-time educational video |
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Limitations of the study include a small sample size, and minimal heterogeneity of gender, and race. We were limited to one geographical region.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ashley Pfeiffer | Black Hills State University | (605) 381-5370 | ashley.pfeiffer@bhsu.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 | Jan 1, 2023 | Jun 12, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000070263 | Sleep Hygiene |
| D015438 | Health Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
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There will be two arms of the study including intervention and a control group.
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| One-time educational video plus automated text messaging |
| Behavioral |
Educational video plus automated text messaging |
|
Outcome measure for overall function. The participant chooses three functional day-to-day activities that they regularly participate in and they rate those activities from 0-10 on ease or difficulty of completing. 0 indicates unable to perform the activity, and 10 indicates no problem with the activity. The total score is calculated by adding all three activity scores and dividing by the number of activities listed for a total score ranging from 0-10. |
| Baseline and 4-week follow up |
| Change Scores From Baseline to 4-week Follow up for Participant's Body Mass Index | Body mass index is measured by body weight [kg]/ height [m]2) from weight and height measurements to determine healthy body anthropometrics. Normal value is 18.5 to 24.9. Above these values is considered overweight and obese, under this is considered underweight. | baseline and 4-week follow up |
A one-time educational video on best practices for sleep hygiene plus daily automated text messages to reinforce habit.
One-time educational video plus automated text messaging: Educational video plus automated text messaging
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Sleep Hygiene Index | sleep quality measurement. Scores range 0-21 with higher scores indicating poorer sleep quality. Collected through an electronic survey. | Mean | Full Range | units on a scale |
|
|
|
| Primary | Change Score From Baseline to 4-week Follow up on the Sleep Hygiene Index | Outcome measure for good sleep hygiene. Scores range from 0-52. Higher scores equate to worse sleep hygiene. | Average change scores | Posted | Mean | Full Range | units on a scale | Baseline and 4-week follow up |
|
|
|
| Primary | Change Score From Baseline to 4-week Follow up on the Numeric Pain Rating Scale | Outcome measure for average pain levels. Scores range from 0-10. Higher scores equate to higher pain levels. | Average change score | Posted | Mean | Full Range | units on a scale | Baseline and 4-week follow up |
|
|
|
| Primary | Change Score From Baseline to 4-week Follow up on the Epworth Sleepiness Scale | Outcome measure for average daytime sleepiness. Scores range from 0-24. Higher scores equate to worse daytime sleepiness. | average change score on ESS | Posted | Mean | Full Range | units on a scale | Baseline and 4-week follow up |
|
|
|
| Primary | Change Score From Baseline to 4-weeks for Participants' Sleep Efficiency Using Wearable Technology. | Sleep efficiency scores will be calculated using a sleep tracker device and are defined as time spent in bed versus time spent actually sleeping. 85% or higher is considered normal sleep efficiency. The average sleep efficiency score for the first three days at baseline and average sleep efficiency from the last 3 days of the 4 week study period will be used to gather the change score. | Posted | Mean | Full Range | percentage points of efficiency | Baseline, 4-week follow up |
|
|
|
| Secondary | Change Score From Baseline to 4-week Follow up on the Perceived Stress Scale | Outcome measure for average stress levels. Scores range from 0-40. The higher the score the worse the stress levels. | Posted | Mean | Full Range | units on a scale | Baseline and 4-week follow up |
|
|
|
| Secondary | Change Score From Baseline to 4-week Follow up on the Patient Specific Functional Scale | Outcome measure for overall function. The participant chooses three functional day-to-day activities that they regularly participate in and they rate those activities from 0-10 on ease or difficulty of completing. 0 indicates unable to perform the activity, and 10 indicates no problem with the activity. The total score is calculated by adding all three activity scores and dividing by the number of activities listed for a total score ranging from 0-10. | Posted | Mean | Full Range | units on a scale | Baseline and 4-week follow up |
|
|
|
| Secondary | Change Scores From Baseline to 4-week Follow up for Participant's Body Mass Index | Body mass index is measured by body weight [kg]/ height [m]2) from weight and height measurements to determine healthy body anthropometrics. Normal value is 18.5 to 24.9. Above these values is considered overweight and obese, under this is considered underweight. | Posted | Mean | Full Range | kg/m^2 (kilograms/meters squared) | baseline and 4-week follow up |
|
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|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | One-time Educational Video Plus Automated Text Messaging | A one-time educational video on best practices for sleep hygiene plus daily automated text messages to reinforce habit. One-time educational video plus automated text messaging: Educational video plus automated text messaging | 0 | 15 | 0 | 15 | 0 | 15 |
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