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Completed

NCT Number: NCT03835572

CircaHealth Development and Evaluation

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.

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Key information

Conditions

Health Behavior Behavior Behavioral Symptoms Burnout, Psychological Circadian Rhythm Health Knowledge, Attitudes, Practice Sleep Hygiene Stress, Psychological

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami Miller School of Medicine

Miami, Florida, 33133, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CircaHealth: a course on circadian rhythms and health

Other

Participants will receive videos, behavioral modification checklists, and quizzes every week for six weeks.

Sleep hygiene materials

Other

Participants in the control group will receive weekly materials from the National Sleep Foundation and American Academy of Sleep Medicine on sleep hygiene

Primary outcomes

  1. Participant completion rate of CircaHealth

    Time frame: 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.

  2. Participant qualitative feedback on CircaHealth

    Time frame: 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.

Secondary outcomes

  1. Change in Epworth Sleepiness Scale scores four weeks after the completion of CircaHealth

    Time frame: Ten weeks

    To determine if Epworth Sleepiness Scale scores improved four weeks after completion of the educational intervention in comparison to the control group.

  2. Change in Pittsburgh Sleep Quality Index scores four weeks after the completion of CircaHealth

    Time frame: 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.

  3. Change in Munich Chronotype scores four weeks after the completion of CircaHealth

    Time frame: Ten weeks

    To determine if Munich Chronotype scores improved four weeks after completion of the educational intervention in comparison to the control group.

  4. Change in Circadian Health Scale scores four weeks after the completion of CircaHealth

    Time frame: Ten weeks

    To determine if Circadian Health Scale scores improved four weeks after completion of the educational intervention in comparison to the control group.

  5. Change in Maslach General Survey for Students scores four weeks after the completion of CircaHealth

    Time frame: 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.

Other outcomes

  1. Association between Epworth Sleepiness Scale scores and Circadian Health Scale scores

    Time frame: Ten weeks

    To determine if Epworth Sleepiness Scale scores are associated with Circadian Health Scale scores

  2. Association between Pittsburgh Sleep Quality Index scores and Circadian Health Scale scores

    Time frame: Ten weeks

    To determine if Pittsburgh Sleep Quality Index scores are associated with Circadian Health Scale scores

  3. Association between Munich Chronotype scores and Circadian Health Scale scores

    Time frame: Ten weeks

    To determine if Munich Chronotype scores are associated with Circadian Health Scale scores

  4. Association between Maslach General Survey for Students scores and Circadian Health Scale scores

    Time frame: Ten weeks

    To determine if Maslach General Survey for Students scores are associated with Circadian Health Scale scores

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • Quantum Foundation

Registry information

Official study title

Evaluation of Circadian Health Educational Tool

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 8, 2019
Registry last updated
May 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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