Trial Outcomes & Findings for The EMS Sleep Health Study: A Randomized Controlled Trial (NCT NCT04218279)

Last Updated: 2022-04-05

Results Overview

Sleep quality will be measured with the Pittsburgh Sleep Quality Index (PSQI) tool. Scores range from 0-21 with scores greater than or equal to 6 classified as poor sleep quality.

Recruitment status

TERMINATED

Study phase

Target enrollment

678 participants

Primary outcome timeframe

baseline to 3 months

Results posted on

2022-04-05

Participant Flow

Unit of analysis: EMS Agencies

Participant milestones

Participant milestones
Measure	Sleep Health Education At baseline, the experimental group will have immediate access to 10 brief education modules focused on diverse elements of sleep health and fatigue. Sleep Health Education: Intervention materials include 10 brief education modules that the target population will review/view on a secure study-specific website.	Wait List Control At 3 months after baseline, the wait-list control group will be provided access to the 10 education modules focused on diverse elements of sleep health and fatigue.. Sleep Health Education: Intervention materials include 10 brief education modules that the target population will review/view on a secure study-specific website.
Overall Study STARTED	316 16	362 20
Overall Study COMPLETED	211 15	225 20
Overall Study NOT COMPLETED	105 1	137 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Some participants did not answer the question about sex.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: baseline to 3 months

Population: Complete cases

Sleep quality will be measured with the Pittsburgh Sleep Quality Index (PSQI) tool. Scores range from 0-21 with scores greater than or equal to 6 classified as poor sleep quality.

Outcome measures

Outcome measures
Measure	Sleep Health Education n=209 Participants At baseline, the experimental group will have immediate access to 10 brief education modules focused on diverse elements of sleep health and fatigue. Sleep Health Education: Intervention materials include 10 brief education modules that the target population will review/view on a secure study-specific website.	Wait List Control n=223 Participants At 3 months after baseline, the wait-list control group will be provided access to the 10 education modules focused on diverse elements of sleep health and fatigue.. Sleep Health Education: Intervention materials include 10 brief education modules that the target population will review/view on a secure study-specific website.
Change From Baseline in Sleep Quality at 3 Months	-0.53 units on a scale Standard Deviation 2.64	-0.08 units on a scale Standard Deviation 2.60

SECONDARY outcome

Timeframe: baseline to 3 months

Population: Complete cases

Fatigue will be measured with the Chalder Fatigue Questionnaire (CFQ). The CFQ is a brief 11-item survey tool that measures mental and physical fatigue with scores ranging from 0-11. Scores 4 or greater indicate severe fatigue.

Outcome measures

Outcome measures
Measure	Sleep Health Education n=208 Participants At baseline, the experimental group will have immediate access to 10 brief education modules focused on diverse elements of sleep health and fatigue. Sleep Health Education: Intervention materials include 10 brief education modules that the target population will review/view on a secure study-specific website.	Wait List Control n=222 Participants At 3 months after baseline, the wait-list control group will be provided access to the 10 education modules focused on diverse elements of sleep health and fatigue.. Sleep Health Education: Intervention materials include 10 brief education modules that the target population will review/view on a secure study-specific website.
Change From Baseline in Fatigue at 3 Months	0.19 units on a scale Standard Deviation 2.23	0.01 units on a scale Standard Deviation 2.45

Adverse Events

Sleep Health Education

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Wait List Control

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

P. Daniel Patterson

University of Pittsburgh

Phone: 412-864-3830

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Sleep Health Education n=316 Participants At baseline, the experimental group will have immediate access to 10 brief education modules focused on diverse elements of sleep health and fatigue. Sleep Health Education: Intervention materials include 10 brief education modules that the target population will review/view on a secure study-specific website.	Wait List Control n=362 Participants At 3 months after baseline, the wait-list control group will be provided access to the 10 education modules focused on diverse elements of sleep health and fatigue.. Sleep Health Education: Intervention materials include 10 brief education modules that the target population will review/view on a secure study-specific website.	Total n=678 Participants Total of all reporting groups
Age, Continuous	39.3 years STANDARD_DEVIATION 9.6 • n=316 Participants	37.4 years STANDARD_DEVIATION 10.1 • n=362 Participants	38.3 years STANDARD_DEVIATION 9.9 • n=678 Participants
Sex: Female, Male Female	97 Participants n=302 Participants • Some participants did not answer the question about sex.	92 Participants n=347 Participants • Some participants did not answer the question about sex.	189 Participants n=649 Participants • Some participants did not answer the question about sex.
Sex: Female, Male Male	205 Participants n=302 Participants • Some participants did not answer the question about sex.	255 Participants n=347 Participants • Some participants did not answer the question about sex.	460 Participants n=649 Participants • Some participants did not answer the question about sex.
Ethnicity (NIH/OMB) Hispanic or Latino	16 Participants n=302 Participants • Some participants did not complete the survey.	18 Participants n=348 Participants • Some participants did not complete the survey.	34 Participants n=650 Participants • Some participants did not complete the survey.
Ethnicity (NIH/OMB) Not Hispanic or Latino	274 Participants n=302 Participants • Some participants did not complete the survey.	322 Participants n=348 Participants • Some participants did not complete the survey.	596 Participants n=650 Participants • Some participants did not complete the survey.
Ethnicity (NIH/OMB) Unknown or Not Reported	12 Participants n=302 Participants • Some participants did not complete the survey.	8 Participants n=348 Participants • Some participants did not complete the survey.	20 Participants n=650 Participants • Some participants did not complete the survey.
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=302 Participants • Some participants did not complete the survey.	7 Participants n=348 Participants • Some participants did not complete the survey.	10 Participants n=650 Participants • Some participants did not complete the survey.
Race (NIH/OMB) Asian	0 Participants n=302 Participants • Some participants did not complete the survey.	2 Participants n=348 Participants • Some participants did not complete the survey.	2 Participants n=650 Participants • Some participants did not complete the survey.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=302 Participants • Some participants did not complete the survey.	0 Participants n=348 Participants • Some participants did not complete the survey.	0 Participants n=650 Participants • Some participants did not complete the survey.
Race (NIH/OMB) Black or African American	1 Participants n=302 Participants • Some participants did not complete the survey.	4 Participants n=348 Participants • Some participants did not complete the survey.	5 Participants n=650 Participants • Some participants did not complete the survey.
Race (NIH/OMB) White	284 Participants n=302 Participants • Some participants did not complete the survey.	320 Participants n=348 Participants • Some participants did not complete the survey.	604 Participants n=650 Participants • Some participants did not complete the survey.
Race (NIH/OMB) More than one race	8 Participants n=302 Participants • Some participants did not complete the survey.	8 Participants n=348 Participants • Some participants did not complete the survey.	16 Participants n=650 Participants • Some participants did not complete the survey.
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=302 Participants • Some participants did not complete the survey.	7 Participants n=348 Participants • Some participants did not complete the survey.	13 Participants n=650 Participants • Some participants did not complete the survey.
Mean Pittsburgh Sleep Quality Index Score	8.77 units on a scale STANDARD_DEVIATION 3.3 • n=316 Participants	8.96 units on a scale STANDARD_DEVIATION 3.6 • n=362 Participants	8.87 units on a scale STANDARD_DEVIATION 3.5 • n=678 Participants
Mean Chadler Fatigue Questionnaire Score	6.64 units on a scale STANDARD_DEVIATION 2.6 • n=302 Participants • Some participants did not complete the survey.	6.55 units on a scale STANDARD_DEVIATION 2.8 • n=348 Participants • Some participants did not complete the survey.	6.6 units on a scale STANDARD_DEVIATION 2.7 • n=650 Participants • Some participants did not complete the survey.