NCT03835572

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 8, 2019

Completed
15 days until next milestone

Study Start

First participant enrolled

February 23, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2019

Completed
Last Updated

May 9, 2019

Status Verified

May 1, 2019

Enrollment Period

2 months

First QC Date

February 5, 2019

Last Update Submit

May 8, 2019

Conditions

Health BehaviorHealth Knowledge, Attitudes, PracticeCircadian Rhythm

Keywords

Circadian RhythmEducationStudent burnoutSleep Hygiene

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (5)

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

    Ten weeks

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

    Ten weeks

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

    Ten weeks

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

    Ten weeks

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

    Ten weeks

Other Outcomes (4)

  • Association between Epworth Sleepiness Scale scores and Circadian Health Scale scores

    Ten weeks

  • Association between Pittsburgh Sleep Quality Index scores and Circadian Health Scale scores

    Ten weeks

  • Association between Munich Chronotype scores and Circadian Health Scale scores

    Ten weeks

  • +1 more other outcomes

Study Arms (2)

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.

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.

Other: Sleep hygiene materials

Interventions

CircaHealth: a course on circadian rhythms and healthOTHER

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

CircaHealth
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

Sleep hygiene materials

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Medical students, 1st through 4th year, at the University of Miami Miller School of Medicine willing to participate in surveys and the CircaHealth course.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami Miller School of Medicine

Miami, Florida, 33133, United States

Location

MeSH Terms

Conditions

Health BehaviorBehaviorBurnout, PsychologicalSleep Hygiene

Interventions

Health

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral Symptoms

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Officials

  • Tulay Koru-Sengal, Ph.D.

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Participants will be assigned a study ID such that the investigators cannot determine the identify of the participants or which arm of the study each participant is in.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be assigned to receive the online educational course or materials on sleep hygiene for six weeks.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Student Doctor

Study Record Dates

First Submitted

February 5, 2019

First Posted

February 8, 2019

Study Start

February 23, 2019

Primary Completion

May 8, 2019

Study Completion

May 8, 2019

Last Updated

May 9, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)