Health Behavior, Sleep Habit, Good, Sleep Hygiene
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALOne-time educational video
One-time educational video
BEHAVIORALOne-time educational video plus automated text messaging
Educational video plus automated text messaging
Sponsors
National Institute of General Medical Sciences (NIGMS)
Black Hills State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
There will be two arms of the study including intervention and a control group.
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Any adult between the ages of 50 and 80 will be recruited for the study
Exclusion criteria
* Anyone with a diagnosed sleep disorder such as insomnia or obstructive sleep apnea, and the inability to wear any sleep tracking device on their wrist.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change Score From Baseline to 4-weeks for Participants' Sleep Efficiency Using Wearable Technology. | Baseline, 4-week follow up | 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. |
| Change Score From Baseline to 4-week Follow up on the Sleep Hygiene Index | Baseline and 4-week follow up | Outcome measure for good sleep hygiene. Scores range from 0-52. Higher scores equate to worse sleep hygiene. |
| Change Score From Baseline to 4-week Follow up on the Numeric Pain Rating Scale | Baseline and 4-week follow up | Outcome measure for average pain levels. Scores range from 0-10. Higher scores equate to higher pain levels. |
| Change Score From Baseline to 4-week Follow up on the Epworth Sleepiness Scale | Baseline and 4-week follow up | Outcome measure for average daytime sleepiness. Scores range from 0-24. Higher scores equate to worse daytime sleepiness. |
| Change Score From Baseline to 4-week Follow up on the Pittsburgh Sleep Quality Index | Baseline and 4-week follow up | Outcome measure for quality of sleep. Score ranges 0-21 with higher score equaling poor sleep quality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change Score From Baseline to 4-week Follow up on the Patient Specific Functional Scale | Baseline and 4-week follow up | 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. |
| Change Scores From Baseline to 4-week Follow up for Participant's Body Mass Index | baseline and 4-week follow up | 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. |
| Change Score From Baseline to 4-week Follow up on the Perceived Stress Scale | Baseline and 4-week follow up | Outcome measure for average stress levels. Scores range from 0-40. The higher the score the worse the stress levels. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| One-time Educational Video A one-time educational video on best practices for good sleep hygiene
One-time educational video: One-time educational video | 15 |
| 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 | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | One-time Educational Video | One-time Educational Video Plus Automated Text Messaging | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 11 Participants | 8 Participants | 19 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 7 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants | 14 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 15 Participants | 14 Participants | 29 Participants |
| Region of Enrollment United States | 15 participants | 15 participants | 30 participants |
| Sex: Female, Male Female | 12 Participants | 12 Participants | 24 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 6 Participants |
| Sleep Hygiene Index | 6.7 units on a scale | 8.7 units on a scale | 7.7 units on a scale |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
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.
Time frame: Baseline and 4-week follow up
Population: average change score on ESS
| Arm | Measure | Value (MEAN) |
|---|---|---|
| One-time Educational Video | Change Score From Baseline to 4-week Follow up on the Epworth Sleepiness Scale | 1.3 units on a scale |
| One-time Educational Video Plus Automated Text Messaging | Change Score From Baseline to 4-week Follow up on the Epworth Sleepiness Scale | 2.3 units on a scale |
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.
Time frame: Baseline and 4-week follow up
Population: Average change score
| Arm | Measure | Value (MEAN) |
|---|---|---|
| One-time Educational Video | Change Score From Baseline to 4-week Follow up on the Numeric Pain Rating Scale | 0.1 units on a scale |
| One-time Educational Video Plus Automated Text Messaging | Change Score From Baseline to 4-week Follow up on the Numeric Pain Rating Scale | 0.1 units on a scale |
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
Time frame: Baseline and 4-week follow up
Population: Change score average
| Arm | Measure | Value (MEAN) |
|---|---|---|
| One-time Educational Video | Change Score From Baseline to 4-week Follow up on the Pittsburgh Sleep Quality Index | 1.6 units on a scale |
| One-time Educational Video Plus Automated Text Messaging | Change Score From Baseline to 4-week Follow up on the Pittsburgh Sleep Quality Index | 2.5 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.
Time frame: Baseline and 4-week follow up
Population: Average change scores
| Arm | Measure | Value (MEAN) |
|---|---|---|
| One-time Educational Video | Change Score From Baseline to 4-week Follow up on the Sleep Hygiene Index | 5.5 units on a scale |
| One-time Educational Video Plus Automated Text Messaging | Change Score From Baseline to 4-week Follow up on the Sleep Hygiene Index | 3.5 units on a scale |
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.
Time frame: Baseline, 4-week follow up
| Arm | Measure | Value (MEAN) |
|---|---|---|
| One-time Educational Video | Change Score From Baseline to 4-weeks for Participants' Sleep Efficiency Using Wearable Technology. | -1.34 percentage points of efficiency |
| One-time Educational Video Plus Automated Text Messaging | Change Score From Baseline to 4-weeks for Participants' Sleep Efficiency Using Wearable Technology. | -0.2 percentage points of efficiency |
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.
Time frame: Baseline and 4-week follow up
| Arm | Measure | Value (MEAN) |
|---|---|---|
| One-time Educational Video | Change Score From Baseline to 4-week Follow up on the Patient Specific Functional Scale | 1.3 units on a scale |
| One-time Educational Video Plus Automated Text Messaging | Change Score From Baseline to 4-week Follow up on the Patient Specific Functional Scale | 0.16 units on a scale |
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.
Time frame: Baseline and 4-week follow up
| Arm | Measure | Value (MEAN) |
|---|---|---|
| One-time Educational Video | Change Score From Baseline to 4-week Follow up on the Perceived Stress Scale | 3.1 units on a scale |
| One-time Educational Video Plus Automated Text Messaging | Change Score From Baseline to 4-week Follow up on the Perceived Stress Scale | 1.9 units on a scale |
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.
Time frame: baseline and 4-week follow up
| Arm | Measure | Value (MEAN) |
|---|---|---|
| One-time Educational Video | Change Scores From Baseline to 4-week Follow up for Participant's Body Mass Index | -0.001 kg/m^2 (kilograms/meters squared) |
| One-time Educational Video Plus Automated Text Messaging | Change Scores From Baseline to 4-week Follow up for Participant's Body Mass Index | 0.13 kg/m^2 (kilograms/meters squared) |