CircaHealth Development and Evaluation

NCT ID: NCT03835572

Last Updated: 2019-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-23

Study Completion Date

2019-05-08

Brief Summary

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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

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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.

Conditions

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Health Behavior Health Knowledge, Attitudes, Practice Circadian Rhythm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be assigned to receive the online educational course or materials on sleep hygiene for six weeks.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
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.

Study Groups

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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.

Group Type EXPERIMENTAL

CircaHealth: a course on circadian rhythms and health

Intervention Type OTHER

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

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.

Group Type ACTIVE_COMPARATOR

Sleep hygiene materials

Intervention Type OTHER

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

Interventions

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CircaHealth: a course on circadian rhythms and health

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

Intervention Type OTHER

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

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Quantum Foundation

UNKNOWN

Sponsor Role collaborator

University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Dylan Petkus

Student Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tulay Koru-Sengal, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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University of Miami Miller School of Medicine

Miami, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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20180932

Identifier Type: -

Identifier Source: org_study_id

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