CClinicalTrials.gg
Status unknownNCT03304574Updated Sep 6, 2018

CheckED Yourself Study

An interventional study of Integrated personalized feedback in Adolescent Behavior, Risk Behavior and Motivation, sponsored by Seattle Children's Hospital. Status unknown at 1 site in United States. Open to participants aged 13 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-06.

Sponsored by Seattle Children's Hospital · Not applicable, Interventional, and Screening

The sponsor has not verified this record recently (last verified Sep 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
13 Years to 18 Years
Sex
All
01

Study summary

During adolescence, the most common causes of morbidity and mortality are related to risky behaviors. The American Academy of Pediatrics recommends that adolescents be screened for these behaviors during primary care visits, but many adolescents do not receive the recommended risk behavior screening and counseling, in part because they are infrequently seen in primary care. The objective of this study is to evaluate if the electronic health screening tool, which includes an electronic health assessment with integrated personalized feedback, reduces risk behaviors in adolescents seen in the Emergency Department (ED).

Read the detailed description

Adolescents and their parents (if participant is under the age of 18 years) will be approached and invited to participate in the study during their Emergency Department (ED) visit. Following consent, adolescents will be randomized to the intervention or control group. A tablet computer will be provided to the participants for use during their baseline assessment in the ED. The CheckED Yourself App will be pre-loaded on the tablet. The CheckED Yourself App (eHA-IPF) is an innovative electronic health screening tool with integrated personalized feedback about risk behaviors. The CheckED Yourself App (eHA-IPF) will be divided into an assessment about risk behaviors and a personalized feedback portion. Participants will be randomized to a control or intervention group at the time of consent. Those in the intervention group will receive both parts of the CheckED Yourself App, while the control group will receive only the assessment with no feedback.

Those in the Intervention arm will complete the health risk behavior assessment and receive integrated personalized feedback from the CheckED Yourself App (eHA-IPF), and those in the control group will complete the health risk behavior assessment only. Participants will complete the questionnaire at some point during their ED visit and prior to discharge.

Follow-up assessments will be completed at 1-day and 3 months post ED visit via an online survey. Reminders for the 1-day and 3-month follow-ups will be sent via email or text message. The 1-day assessment will focus on adolescent-reported motivation to make a health behavior change, the content of the ED visit including what, if any, risk behaviors their ED provider discussed with the participant, and satisfaction with care in the ED. The 3-month assessment will include a re-assessment of risk behaviors.

02

Conditions studied

  • Adolescent Behavior
  • Risk Behavior
  • Motivation
03

Who can participate

Ages eligible
13 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 13-18 years of age
  • Ability of patient and parent of patient \<18 years old to fluently speak and read English
  • Has email address and/or cell phone

Exclusion criteria

Exclusion Criteria:

  • Inability to independently complete the assessment due to intellectual disability
  • Acute cognitive impairment due to injury and/or intoxication
  • Administration of IV sedation or pain medications during Emergency Department visit
  • Presenting to the Emergency Department due to a psychiatric or mental health complaint
  • Emergency Department visit results in hospital admission
04

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
300 participants (estimated)

Study arms

  • No intervention
    Control

    Participants will complete the electronic health assessment only and will not receive integrated personalized feedback

  • Experimental
    Intervention

    Participants will complete the electronic health assessment and will receive integrated personalized feedback

    Behavioral: Integrated personalized feedback

Interventions

  • BehavioralIntegrated personalized feedback

    Integrated personalized feedback about self-reported risk behaviors will be generated and shown to participants as they complete their baseline health risk assessment using the CheckED Yourself app. The integrated personalized feedback is based on motivational feedback strategies such as normative feedback (comparison to peer behaviors and age-based health guidelines), increasing knowledge regarding potential consequences of behaviors, and providing practical tips for changing behavior.

05

What researchers measure

Primary outcomes

  1. Motivation to change

    To evaluate if adolescents who received integrated personalized feedback had higher levels of motivation to change their risk behaviors post-Emergency Department visit compared to adolescents who completed the electronic health assessment only and did not receive personalized feedback

    Time frame: We anticipate measuring this outcome by September 30, 2018, 6 months after recruitment has closed.

  2. Decreased risk behaviors

    To evaluate if adolescents who received integrated personalized feedback reported decreased risk behaviors 3 months post-Emergency Department visit compared to adolescents who completed the electronic health assessment only and did not receive personalized feedback.

    Time frame: We anticipate measuring this outcome by September 30, 2018, 6 months after recruitment has closed.

  3. Prevalence of risk behaviors

    To describe the prevalence of risk behaviors among adolescents who present to the Emergency Department for care.

    Time frame: We anticipate measuring this outcome by September 30, 2018, 6 months after recruitment has closed.

06

Study locations

1 of 1 sites recruiting
  • Seattle Children's Hospital
    Seattle, Washington 98105, United States
    • Lindsey Johnson · Contact · lindsey.johnson@seattlechildrens.org · 206-884-1075
    • Taraneh Shafii, MD, MPH · Principal investigator
    • Eileen Klein, MD, MPH · Sub investigator
    • Siobhan Thomas-Smith, MD · Sub investigator
    • Stephanie Richling, MD · Sub investigator
    • Laura Richardson, MD · Sub investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: No — N/A IPD will not be shared

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03304574
Lead sponsor
Seattle Children's Hospital
Responsible party
Taraneh Shafii (Associate Professor, Seattle Children's Hospital) — Principal investigator
First posted
Oct 9, 2017
Start date
Mar 1, 2017
Primary completion
Oct 1, 2018 (estimated)
Completion
Nov 30, 2018 (estimated)
Last update
Sep 6, 2018

Study contacts

Taraneh Shafii, MD, MPH
Contact
taraneh.shafii@seattlechildrens.org
206-987-2028
Eileen Klein, MD, MPH
Contact
eileen.klein@seattlechildrens.org
206-987-2708

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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