CircaHealth Development and Evaluation
May 8, 2019 updated by: Dylan Petkus, University of Miami
Evaluation of Circadian Health Educational Tool
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
54
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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Miami, Florida, United States, 33133
- University of Miami Miller School of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: CircaHealth
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.
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Participants will receive videos, behavioral modification checklists, and quizzes every week for six weeks.
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ACTIVE_COMPARATOR: 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.
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Participants in the control group will receive weekly materials from the National Sleep Foundation and American Academy of Sleep Medicine on sleep hygiene
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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Six weeks
|
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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.
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Six weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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Ten weeks
|
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Change in Pittsburgh Sleep Quality Index scores four weeks after the completion of CircaHealth
Time Frame: Ten weeks
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To determine if Pittsburgh Sleep Quality Index scores improved four weeks after completion of the educational intervention in comparison to the control group.
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Ten weeks
|
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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.
|
Ten weeks
|
|
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.
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Ten weeks
|
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Change in Maslach General Survey for Students scores four weeks after the completion of CircaHealth
Time Frame: Ten weeks
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To determine if Maslach General Survey for Students scores improved four weeks after completion of the educational intervention in comparison to the control group.
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Ten weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
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Ten weeks
|
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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
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Ten weeks
|
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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
|
Ten weeks
|
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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
|
Ten weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Tulay Koru-Sengal, Ph.D., University of Miami
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 23, 2019
Primary Completion (ACTUAL)
May 8, 2019
Study Completion (ACTUAL)
May 8, 2019
Study Registration Dates
First Submitted
February 5, 2019
First Submitted That Met QC Criteria
February 7, 2019
First Posted (ACTUAL)
February 8, 2019
Study Record Updates
Last Update Posted (ACTUAL)
May 9, 2019
Last Update Submitted That Met QC Criteria
May 8, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 20180932
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.