Trial Outcomes & Findings for The SleepTrackTXT2 Randomized Trial With Air-medical Personnel (NCT NCT02783027)
NCT ID: NCT02783027
Last Updated: 2019-12-26
Results Overview
Measured by the Pittsburgh Sleep Quality Index (PSQI); Scores range from 0 to 21. Higher scores indicate poorer sleep quality. Scores \>6 indicate poor sleep quality.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
83 participants
Primary outcome timeframe
4 months
Results posted on
2019-12-26
Participant Flow
Participant milestones
| Measure |
SleepTrackTXT2
Participants receive text-message assessment during shift work (intra-shift) and between shifts (inter-shift). Participants in the experimental group that report high levels of fatigue, sleepiness, or difficulty with concentration during shift work (intra-shift) will receive tailored text-messages promoting adoption of behaviors that can improve alertness. Participants will also receive a summary of their sleep debt once a week and suggestions for paying back sleep debt. Participants will also have access to a graphic summary of their sleep hours over previous 30-days.
|
Text-Message Assessments Only
Participants in the non-intervention group/arm will receive text-message based assessment during shift work (intra-shift) and between shifts (inter-shift). The inter-shift assessments will query the participant about his/her sleep hours, fatigue, sleepiness, and difficulty with concentration. No intervention messages sent to this group/arm.
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
44
|
|
Overall Study
COMPLETED
|
16
|
27
|
|
Overall Study
NOT COMPLETED
|
23
|
17
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
2 participants in each group did not complete the age information
Baseline characteristics by cohort
| Measure |
SleepTrackTXT2
n=39 Participants
Participants receive text-message assessment during shift work (intra-shift) and between shifts (inter-shift). Participants in the experimental group that report high levels of fatigue, sleepiness, or difficulty with concentration during shift work (intra-shift) will receive tailored text-messages promoting adoption of behaviors that can improve alertness. Participants will also receive a summary of their sleep debt once a week and suggestions for paying back sleep debt. Participants will also have access to a graphic summary of their sleep hours over previous 30-days.
|
Text-Message Assessments Only
n=44 Participants
Participants in the non-intervention group/arm will receive text-message based assessment during shift work (intra-shift) and between shifts (inter-shift). The inter-shift assessments will query the participant about his/her sleep hours, fatigue, sleepiness, and difficulty with concentration. No intervention messages sent to this group/arm.
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|
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Age, Continuous
|
40.9 years
STANDARD_DEVIATION 9.5 • n=37 Participants • 2 participants in each group did not complete the age information
|
41.8 years
STANDARD_DEVIATION 9.8 • n=42 Participants • 2 participants in each group did not complete the age information
|
41.4 years
STANDARD_DEVIATION 9.7 • n=79 Participants • 2 participants in each group did not complete the age information
|
|
Sex: Female, Male
Female
|
19 Participants
n=38 Participants • 1 participant in the intervention group and 2 in the control did not complete sex information
|
15 Participants
n=42 Participants • 1 participant in the intervention group and 2 in the control did not complete sex information
|
34 Participants
n=80 Participants • 1 participant in the intervention group and 2 in the control did not complete sex information
|
|
Sex: Female, Male
Male
|
19 Participants
n=38 Participants • 1 participant in the intervention group and 2 in the control did not complete sex information
|
27 Participants
n=42 Participants • 1 participant in the intervention group and 2 in the control did not complete sex information
|
46 Participants
n=80 Participants • 1 participant in the intervention group and 2 in the control did not complete sex information
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Most Common Shift Length
24 Hours
|
18 Participants
n=38 Participants • 1 participant in each group did not complete the shift length question on the baseline assessment.
|
21 Participants
n=43 Participants • 1 participant in each group did not complete the shift length question on the baseline assessment.
|
39 Participants
n=81 Participants • 1 participant in each group did not complete the shift length question on the baseline assessment.
|
|
Most Common Shift Length
12 Hours
|
18 Participants
n=38 Participants • 1 participant in each group did not complete the shift length question on the baseline assessment.
|
22 Participants
n=43 Participants • 1 participant in each group did not complete the shift length question on the baseline assessment.
|
40 Participants
n=81 Participants • 1 participant in each group did not complete the shift length question on the baseline assessment.
|
|
Most Common Shift Length
Other
|
2 Participants
n=38 Participants • 1 participant in each group did not complete the shift length question on the baseline assessment.
|
0 Participants
n=43 Participants • 1 participant in each group did not complete the shift length question on the baseline assessment.
|
2 Participants
n=81 Participants • 1 participant in each group did not complete the shift length question on the baseline assessment.
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PRIMARY outcome
Timeframe: 4 monthsPopulation: Individuals with outcome measured at 4 months.
Measured by the Pittsburgh Sleep Quality Index (PSQI); Scores range from 0 to 21. Higher scores indicate poorer sleep quality. Scores \>6 indicate poor sleep quality.
Outcome measures
| Measure |
SleepTrackTXT2
n=16 Participants
Participants receive text-message assessment during shift work (intra-shift) and between shifts (inter-shift). Participants in the experimental group that report high levels of fatigue, sleepiness, or difficulty with concentration during shift work (intra-shift) will receive tailored text-messages promoting adoption of behaviors that can improve alertness. Participants will also receive a summary of their sleep debt once a week and suggestions for paying back sleep debt. Participants will also have access to a graphic summary of their sleep hours over previous 30-days.
|
Text-Message Assessments Only
n=27 Participants
Participants in the non-intervention group/arm will receive text-message based assessment during shift work (intra-shift) and between shifts (inter-shift). The inter-shift assessments will query the participant about his/her sleep hours, fatigue, sleepiness, and difficulty with concentration. No intervention messages sent to this group/arm.
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|---|---|---|
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Sleep Quality
|
7.9 score on a scale
Standard Deviation 3.6
|
6.5 score on a scale
Standard Deviation 4.0
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SECONDARY outcome
Timeframe: Every 4 hours up to 12 hours within work shiftsPopulation: Participants with at least some intra-shift data on fatigue.
Single item measure of fatigue taken at beginning, every 4-hours, and at the end of shifts. Scores range from 0 (Not at all) to 5 (Very much); higher scores indicate more fatigue.
Outcome measures
| Measure |
SleepTrackTXT2
n=35 Participants
Participants receive text-message assessment during shift work (intra-shift) and between shifts (inter-shift). Participants in the experimental group that report high levels of fatigue, sleepiness, or difficulty with concentration during shift work (intra-shift) will receive tailored text-messages promoting adoption of behaviors that can improve alertness. Participants will also receive a summary of their sleep debt once a week and suggestions for paying back sleep debt. Participants will also have access to a graphic summary of their sleep hours over previous 30-days.
|
Text-Message Assessments Only
n=41 Participants
Participants in the non-intervention group/arm will receive text-message based assessment during shift work (intra-shift) and between shifts (inter-shift). The inter-shift assessments will query the participant about his/her sleep hours, fatigue, sleepiness, and difficulty with concentration. No intervention messages sent to this group/arm.
|
|---|---|---|
|
Fatigue During Shiftwork
Start of Shift
|
0.71 score on a scale
Interval 0.36 to 1.06
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0.79 score on a scale
Interval 0.46 to 1.12
|
|
Fatigue During Shiftwork
4 hours
|
0.96 score on a scale
Interval 0.61 to 1.31
|
1.10 score on a scale
Interval 0.77 to 1.43
|
|
Fatigue During Shiftwork
8 hours
|
1.45 score on a scale
Interval 1.1 to 1.8
|
1.79 score on a scale
Interval 1.46 to 2.12
|
|
Fatigue During Shiftwork
12 hours (end of shift)
|
1.5 score on a scale
Interval 1.14 to 1.84
|
2.19 score on a scale
Interval 1.86 to 2.51
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SECONDARY outcome
Timeframe: Every 4 hours up to 12 hours within a work shiftPopulation: Individuals with shift data up to 30 days
Single item measure of sleepiness taken at beginning, every 4-hours, and at the end of shifts. Scores range from 0 (Not at all) to 5 (Very much). Higher scores indicate more sleepiness.
Outcome measures
| Measure |
SleepTrackTXT2
n=35 Participants
Participants receive text-message assessment during shift work (intra-shift) and between shifts (inter-shift). Participants in the experimental group that report high levels of fatigue, sleepiness, or difficulty with concentration during shift work (intra-shift) will receive tailored text-messages promoting adoption of behaviors that can improve alertness. Participants will also receive a summary of their sleep debt once a week and suggestions for paying back sleep debt. Participants will also have access to a graphic summary of their sleep hours over previous 30-days.
|
Text-Message Assessments Only
n=41 Participants
Participants in the non-intervention group/arm will receive text-message based assessment during shift work (intra-shift) and between shifts (inter-shift). The inter-shift assessments will query the participant about his/her sleep hours, fatigue, sleepiness, and difficulty with concentration. No intervention messages sent to this group/arm.
|
|---|---|---|
|
Sleepiness During Shiftwork
8 hours
|
1.48 score on a scale
Interval 1.12 to 1.83
|
2.01 score on a scale
Interval 1.68 to 2.34
|
|
Sleepiness During Shiftwork
Start of shift
|
0.84 score on a scale
Interval 0.49 to 1.19
|
0.82 score on a scale
Interval 0.49 to 1.15
|
|
Sleepiness During Shiftwork
4 hours
|
1.01 score on a scale
Interval 0.66 to 1.35
|
1.29 score on a scale
Interval 0.96 to 1.61
|
|
Sleepiness During Shiftwork
12 hours at shift end
|
1.62 score on a scale
Interval 1.27 to 1.97
|
2.50 score on a scale
Interval 2.15 to 2.8
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SECONDARY outcome
Timeframe: Every 4 hours up to 12 hours at end of work shiftPopulation: Number with shift data at 30 days
Single item measure of difficulty with concentration taken at beginning, every 4-hours, and at the end of shifts. Scores range from 0 (Not at all) to 5 (Very much). Higher scores indicate more difficulty with concentration.
Outcome measures
| Measure |
SleepTrackTXT2
n=35 Participants
Participants receive text-message assessment during shift work (intra-shift) and between shifts (inter-shift). Participants in the experimental group that report high levels of fatigue, sleepiness, or difficulty with concentration during shift work (intra-shift) will receive tailored text-messages promoting adoption of behaviors that can improve alertness. Participants will also receive a summary of their sleep debt once a week and suggestions for paying back sleep debt. Participants will also have access to a graphic summary of their sleep hours over previous 30-days.
|
Text-Message Assessments Only
n=41 Participants
Participants in the non-intervention group/arm will receive text-message based assessment during shift work (intra-shift) and between shifts (inter-shift). The inter-shift assessments will query the participant about his/her sleep hours, fatigue, sleepiness, and difficulty with concentration. No intervention messages sent to this group/arm.
|
|---|---|---|
|
Difficulty With Concentration During Shiftwork
Start of shift
|
0.52 score on a scale
Interval 0.19 to 0.86
|
0.46 score on a scale
Interval 0.15 to 0.77
|
|
Difficulty With Concentration During Shiftwork
4 hours
|
0.68 score on a scale
Interval 0.35 to 1.02
|
0.71 score on a scale
Interval 0.4 to 1.03
|
|
Difficulty With Concentration During Shiftwork
8 hours
|
1.12 score on a scale
Interval 0.78 to 1.45
|
1.27 score on a scale
Interval 0.95 to 1.58
|
|
Difficulty With Concentration During Shiftwork
12 hours end of shift
|
1.12 score on a scale
Interval 0.79 to 1.46
|
1.76 score on a scale
Interval 1.45 to 2.07
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: Participants with survey data at 4 months.
The Occupational Fatigue Exhaustion Recovery Scale Inter-shift Recovery Subscale. Scores range from 0 to 100. Scores 50-100 imply moderate to high recovery.
Outcome measures
| Measure |
SleepTrackTXT2
n=16 Participants
Participants receive text-message assessment during shift work (intra-shift) and between shifts (inter-shift). Participants in the experimental group that report high levels of fatigue, sleepiness, or difficulty with concentration during shift work (intra-shift) will receive tailored text-messages promoting adoption of behaviors that can improve alertness. Participants will also receive a summary of their sleep debt once a week and suggestions for paying back sleep debt. Participants will also have access to a graphic summary of their sleep hours over previous 30-days.
|
Text-Message Assessments Only
n=27 Participants
Participants in the non-intervention group/arm will receive text-message based assessment during shift work (intra-shift) and between shifts (inter-shift). The inter-shift assessments will query the participant about his/her sleep hours, fatigue, sleepiness, and difficulty with concentration. No intervention messages sent to this group/arm.
|
|---|---|---|
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Inter-Shift Recovery
|
51.7 score on a scale
Standard Deviation 20.0
|
56.3 score on a scale
Standard Deviation 18.8
|
Adverse Events
SleepTrackTXT2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Text-Message Assessments Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 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