CircaHealth Development and Evaluation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Circadian Health Educational Tool

Conditions
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Health Behavior, Health Knowledge, Attitudes, Practice, Circadian Rhythm

Intervention / Treatment
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* Other: CircaHealth: a course on circadian rhythms and health
* Other: Sleep hygiene materials


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be assigned to receive the online educational course or materials on sleep hygiene for six weeks.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CircaHealth<br>The CircaHealth group will receive access to an online educational module on circadian rhythms and health as their intervention. Every week for six weeks, these participants will receive a new module that contains videos, quizzes, behavioral modification checklists, and journal prompts. | Other: CircaHealth: a course on circadian rhythms and health<br>* Participants will receive videos, behavioral modification checklists, and quizzes every week for six weeks.<br>|
| Active Comparator: Sleep hygiene materials<br>The control group will receive publicly available materials about sleep hygiene from the National Sleep Foundation and/or the American Academy of Sleep Medicine every week for six weeks as their intervention. | Other: Sleep hygiene materials<br>* Participants in the control group will receive weekly materials from the National Sleep Foundation and American Academy of Sleep Medicine on sleep hygiene<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant completion rate of CircaHealth | Determine how many participants completed all modules within CircaHealth. Participants status in the course will be assessed via survey weekly such that their completion of each module can be determined. | Six weeks | 
| Participant qualitative feedback on CircaHealth | Participants will be surveyed every week on what aspects of CircaHealth were helpful and what aspects of CircaHealth can be improved. This qualitative data will be analyzed to determine which aspects of CircaHealth positively and negatively impacted the educational value of the course. | Six weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Epworth Sleepiness Scale scores four weeks after the completion of CircaHealth | To determine if Epworth Sleepiness Scale scores improved four weeks after completion of the educational intervention in comparison to the control group. | Ten weeks | 
| Change in Pittsburgh Sleep Quality Index scores four weeks after the completion of CircaHealth | To determine if Pittsburgh Sleep Quality Index scores improved four weeks after completion of the educational intervention in comparison to the control group. | Ten weeks | 
| Change in Munich Chronotype scores four weeks after the completion of CircaHealth | To determine if Munich Chronotype scores improved four weeks after completion of the educational intervention in comparison to the control group. | Ten weeks | 
| Change in Circadian Health Scale scores four weeks after the completion of CircaHealth | To determine if Circadian Health Scale scores improved four weeks after completion of the educational intervention in comparison to the control group. | Ten weeks | 
| Change in Maslach General Survey for Students scores four weeks after the completion of CircaHealth | To determine if Maslach General Survey for Students scores improved four weeks after completion of the educational intervention in comparison to the control group. | Ten weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Circadian Rhythm, Education, Student burnout, Sleep Hygiene