CircaHealth Development and Evaluation

Health Behavior Clinical Trial

Official title:

Evaluation of Circadian Health Educational Tool

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03835572
• Other study ID #: 20180932
• Status: Completed
• Phase: N/A
• Start date: February 23, 2019
• Est. completion date: May 8, 2019

Study information

• Verified date: May 2019
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: May 8, 2019
• Est. primary completion date: May 8, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Other:
• CircaHealth: a course on circadian rhythms and health
Participants will receive videos, behavioral modification checklists, and quizzes every week for six weeks.
• Sleep hygiene materials
Participants in the control group will receive weekly materials from the National Sleep Foundation and American Academy of Sleep Medicine on sleep hygiene

Locations

Country	Name	City	State
United States	University of Miami Miller School of Medicine	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Quantum Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Association between Epworth Sleepiness Scale scores and Circadian Health Scale scores	To determine if Epworth Sleepiness Scale scores are associated with Circadian Health Scale scores	Ten weeks
Other	Association between Pittsburgh Sleep Quality Index scores and Circadian Health Scale scores	To determine if Pittsburgh Sleep Quality Index scores are associated with Circadian Health Scale scores	Ten weeks
Other	Association between Munich Chronotype scores and Circadian Health Scale scores	To determine if Munich Chronotype scores are associated with Circadian Health Scale scores	Ten weeks
Other	Association between Maslach General Survey for Students scores and Circadian Health Scale scores	To determine if Maslach General Survey for Students scores are associated with Circadian Health Scale scores	Ten weeks
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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