CircaHealth Development and Evaluation

Not Applicable

Completed

• Conditions: Health Behavior; Health Knowledge, Attitudes, Practice; Circadian Rhythm
• Interventions: Other: Sleep hygiene materials

• Registration Number: NCT03835572
• Lead Sponsor: University of Miami

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-02-05
• Study First Submitted QC: 2019-02-07
• Study First Posted: 2019-02-08
• Study Start: 2019-02-23
• Status Verified: 2019-05
• Primary Completion: 2019-05-08
• Study Completion: 2019-05-08
• Last Update Submitted: 2019-05-08
• Last Update Posted: 2019-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sleep hygiene materials	Sleep hygiene materials	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.

Primary Outcome Measures

Name	Time	Method
Participant qualitative feedback on CircaHealth	Six weeks	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.
Participant completion rate of CircaHealth	Six weeks	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Miami Miller School of Medicine; 🇺🇸 Miami, Florida, United States