- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03177421
Health Information Technology to Improve Bedtime Media Use in Children
January 26, 2022 updated by: Randall Grout, Indiana University
Improving Bedtime Media Use and Sleep Through Health Information Technology
The objective of this study is to use health information technology to implement and evaluate a counseling recommendation for children who suffer from problematic sleep associated with bedtime media use.
Participants will be randomized by clinic to be screened for basic sleep concerns and receive appropriate counseling, or to be screened for sleep concerns and media use, and receive appropriate counseling.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
Children and adolescents are increasingly integrating media and technology into daily life.
A large body of research has shown poor sleep-related outcomes related to media exposure, especially in evening or bedtime hours - a trend that holds true from infancy to adolescence.
Prior research has demonstrated clinic-based interventions can be effective in reducing general screen time.
Yet, little work has been done to leverage existing health information technology to adapt bedtime media use guidelines into sustainable counseling interventions.
This study will develop, implement, and evaluate a computerized, evidence-based decision support intervention for reducing inappropriate childhood bedtime media use and improving sleep measures.
Study Type
Interventional
Enrollment (Actual)
60100
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
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202
- Riley Hospital for Children
-
Indianapolis, Indiana, United States, 46202
- Eskenazi Health
-
-
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
2 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Attend a participating clinic
- Complete a prescreener form in the clinic
Exclusion Criteria:
- None
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: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Bedtime media use and sleep problems
This arm will receive screening for and associated clinical decision support on sleep problems and bedtime media use.
|
Participants will be screened for bedtime media use and sleep problems, and the clinical decision support system will recommend counseling on the respective problems identified on screening.
Other Names:
|
Other: Sleep problems only
This arm will receive screening for and associated clinical decision support on sleep problems only.
|
Participants will be screened for sleep problems, and the clinical decision support system will recommend counseling if problems are identified.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of clinician counseling for problematic bedtime media use and sleep problems
Time Frame: Up to 3 years
|
Up to 3 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in bedtime media use following clinician counseling
Time Frame: Up to 3 years
|
Up to 3 years
|
Change in inadequate sleep quantity following clinician counseling
Time Frame: Up to 3 years
|
Up to 3 years
|
Change in daytime sleepiness following clinician counseling
Time Frame: Up to 3 years
|
Up to 3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Randall W. Grout, MD, MS, Indiana University - Ped Health Services
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)
June 13, 2017
Primary Completion (Actual)
May 31, 2019
Study Completion (Actual)
May 31, 2019
Study Registration Dates
First Submitted
June 2, 2017
First Submitted That Met QC Criteria
June 2, 2017
First Posted (Actual)
June 6, 2017
Study Record Updates
Last Update Posted (Actual)
February 9, 2022
Last Update Submitted That Met QC Criteria
January 26, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- chsr_bedtime-media-cdss_2017
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.
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