Health BehaviorNCT03835572
CircaHealth Development and Evaluation
A study testing CircaHealth: a course on circadian rhythms and health and Sleep hygiene materials in people with Health Behavior and Health Knowledge, Attitudes, Practice, run by University of Miami at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Health Behavior, Health Knowledge, Attitudes, Practice, Circadian Rhythm
- What is being tested?
- CircaHealth: a course on circadian rhythms and health and Sleep hygiene materials
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2019to 8 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Medical students, 1st through 4th year, at the University of Miami Miller School of Medicine willing to participate in surveys and the CircaHealth course.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami Miller School of Medicine
Miami, Florida, 33133
About this study
Official title: 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.
Read the 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.
- Being tested
- CircaHealth: a course on circadian rhythms and health, Sleep hygiene materials
- Keywords
- Circadian Rhythm, Education, Student burnout, Sleep Hygiene
- Medical subject headings
- Health Behavior, Behavior, Burnout, Psychological, Sleep Hygiene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CircaHealth: a course on circadian rhythms and healthOther
Participants will receive videos, behavioral modification checklists, and quizzes every week for six weeks.
Sleep hygiene materialsOther
Participants in the control group will receive weekly materials from the National Sleep Foundation and American Academy of Sleep Medicine on sleep hygiene
| Study group | Role | What they receive |
|---|---|---|
| CircaHealth | Experimental | 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. Receives: Other: CircaHealth: a course on circadian rhythms and health |
| Sleep hygiene materials | Active comparator | 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. Receives: Other: Sleep hygiene materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Six weeks
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Ten weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2019
- Study start23 Feb 2019
- Primary completion8 May 2019
- Study completion8 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned to receive the online educational course or materials on sleep hygiene for six weeks.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Quantum Foundation
- Responsible party
- Principal investigator, Dylan Petkus, University of Miami
- Investigators
- Tulay Koru-Sengal, Ph.D., Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03835572
- Sponsor's protocol ID
- 20180932
- Status last verified
- May 2019
- First submitted
- 5 Feb 2019
- Last updated
- 9 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Circadian Health Educational Tool
- ClinicalTrials.gov ID
- NCT03835572
- Acronym / sponsor ID
- 20180932
- Keywords
- Circadian Rhythm, Education, Student burnout, Sleep Hygiene
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Quantum Foundation
- Study start
- 23 Feb 2019 (actual)
- Primary completion
- 8 May 2019 (actual)
- Study completion
- 8 May 2019 (actual)
- First posted
- 8 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Participants will be assigned to receive the online educational course or materials on sleep hygiene for six weeks.
| Arm | Type | Receives |
|---|---|---|
| CircaHealth | Experimental | Other: CircaHealth: a course on circadian rhythms and healthThe 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. |
| Sleep hygiene materials | Active comparator | Other: Sleep hygiene materialsThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Medical students, 1st through 4th year, at the University of Miami Miller School of Medicine willing to participate in surveys and the CircaHealth course.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CircaHealth: a course on circadian rhythms and healthParticipants will receive videos, behavioral modification checklists, and quizzes every week for six weeks. | Other | CircaHealth |
| Sleep hygiene materialsParticipants in the control group will receive weekly materials from the National Sleep Foundation and American Academy of Sleep Medicine on sleep hygiene | Other | Sleep hygiene materials |
Primary outcome
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.
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.
5 secondary outcomes
Change in Epworth Sleepiness Scale scores four weeks after the completion of CircaHealth
Time frame: Ten weeks
Change in Pittsburgh Sleep Quality Index scores four weeks after the completion of CircaHealth
Time frame: Ten weeks
Change in Munich Chronotype scores four weeks after the completion of CircaHealth
Time frame: Ten weeks
Change in Circadian Health Scale scores four weeks after the completion of CircaHealth
Time frame: Ten weeks
Change in Maslach General Survey for Students scores four weeks after the completion of CircaHealth
Time frame: Ten weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tulay Koru-Sengal, Ph.D. principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CircaHealth: a course on circadian rhythms and health and Sleep hygiene materials in people with Health Behavior and Health Knowledge, Attitudes, Practice, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant completion rate of CircaHealth (time frame: Six weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2019.