Clinical trial NCT03835572: CircaHealth Development and Evaluation
Official title: Evaluation of Circadian Health Educational Tool
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
Health Knowledge, Attitudes, Practice
Circadian Rhythm
Keywords: Circadian Rhythm
Education
Student burnout
Sleep Hygiene
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Quantum Foundation
First posted: 2019-02-08
Enrollment: 54
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be assigned to receive the online educational course or materials on sleep hygiene for six weeks.
Primary purpose: TREATMENT

Brief summary: This study evaluates the feasibility, acceptability, and efficacy of an online education course about circadian rhythms and health. Half of participants will be enrolled into the online course and the other half will receive materials on sleep hygiene as a control.

Detailed description: This is a pilot randomized controlled study that aims to develop CircaHealth: an online course on practices, known as circadian hygiene, that promote circadian rhythm alignment and minimize circadian rhythm misalignment. The project also will determine the feasibility, acceptability, and preliminary effects of CircaHealth in improving circadian rhythm related measures in University of Miami Miller School of Medicine medical students.

The educational videos will be incorporated into a six-module online course which contains additional educational and behavior modification tools. Medical students (n = 40) will be recruited via email and randomized to receive CircaHealth or materials from the National Sleep Foundation and/or the American Academy of Sleep Medicine. Sleep, mood, and circadian hygiene knowledge, behaviors, and attitudes will be assessed at baseline and four weeks post intervention. Feasibility will be determined by CircaHealth module completion rates, and acceptability will be assessed via a self-report survey. Changes in sleep quality measures between groups will determine the preliminary efficacy of CircaHealth.

Eligibility criteria: Inclusion Criteria:

* Medical students, 1st through 4th year, at the University of Miami Miller School of Medicine willing to participate in surveys and the CircaHealth course.

Primary outcomes:
measure: Participant completion rate of CircaHealth
timeFrame: Six weeks
measure: Participant qualitative feedback on CircaHealth
timeFrame: Six weeks
Secondary outcomes:
measure: Change in Epworth Sleepiness Scale scores four weeks after the completion of CircaHealth
timeFrame: Ten weeks
measure: Change in Pittsburgh Sleep Quality Index scores four weeks after the completion of CircaHealth
timeFrame: Ten weeks
measure: Change in Munich Chronotype scores four weeks after the completion of CircaHealth
timeFrame: Ten weeks
measure: Change in Circadian Health Scale scores four weeks after the completion of CircaHealth
timeFrame: Ten weeks
measure: Change in Maslach General Survey for Students scores four weeks after the completion of CircaHealth
timeFrame: Ten weeks
Other outcomes:
measure: Association between Epworth Sleepiness Scale scores and Circadian Health Scale scores
timeFrame: Ten weeks
measure: Association between Pittsburgh Sleep Quality Index scores and Circadian Health Scale scores
timeFrame: Ten weeks
measure: Association between Munich Chronotype scores and Circadian Health Scale scores
timeFrame: Ten weeks
measure: Association between Maslach General Survey for Students scores and Circadian Health Scale scores
timeFrame: Ten weeks
Locations:
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
Study officials:
affiliation: University of Miami
name: Tulay Koru-Sengal, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: