NCT02360410

Brief Summary

The proposed study is a randomized controlled trial that compares the effectiveness of an electronic personalized health screening app incorporating motivational feedback (i.e., "Check Yourself") to usual care. The purpose of this study is to determine whether Check Yourself is more effective than usual care in reducing health risk behaviors and improving quality of care among adolescents receiving primary health care services.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2015

Typical duration 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

Study Start

First participant enrolled

February 1, 2015

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

February 5, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 10, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

April 18, 2018

Status Verified

April 1, 2018

Enrollment Period

1.8 years

First QC Date

February 5, 2015

Last Update Submit

April 17, 2018

Conditions

Outcome Measures

Primary Outcomes (2)

  • Number of Health risk behaviors

    Total count health-risk behaviors at 3-month follow-up (Score range= 0-13) adjusted by total number of baseline risk behaviors (with risk cut-off): ≥2 sugar-sweetened beverages consumed/day; ≤3 servings fruits/vegetables consumed/day; ≤3 days with 60+ minutes exercise during typical week; ≥3 hours of screen time during typical school day; ≤7 hours of sleep during typical night; not "always" using seatbelt; not "always" using helmet when bicycling; having driven under the influence of substances; days of alcohol consumption in last 30 days (risk based on age: ≥1 day/30 days (ages 13-15), ≥2 days/30 days (ages 16-17), or ≥3 days/30 days (age 18)) and/or number of drinks/drinking episode (risk based on age and sex: ≥3 (Girls 13-17; Boys 13), ≥4 (Girls 18; Boys 14-15), or ≥5 (Boys 16-18)); any tobacco use; any marijuana/other drugs use; not using birth control during last sexual intercourse and/or not "always" using a condom; and ≥10 score on PHQ-9.

    3 months

  • Number of risk behaviors counseled on during primary care appointment

    Number of adolescent-reported high risk health risk behaviors discussed with the healthcare provider during the primary care visit (Score range: 0-13) adjusted for the total number of health risk behaviors reported at baseline. Receipt of counseling/discussion assessed using an adapted version of the Adolescent Report of the Visit (AROV). The AROV includes counseling on the following behaviors: 1) sweetened beverage consumption; 2) fruit/vegetable consumption; 3) physical activity amount; 4) screen time (i.e., watching TV, playing video games, surfing the web, or texting); 5) sleep duration; 6) seat belt use; 7) helmet use while bicycling; 8) drinking/using drugs while driving; 9) alcohol use; 10) tobacco use; 11) marijuana and/or other drug use; 12) condom and/or birth control use; 13) depression and moods.

    1 day

Secondary Outcomes (4)

  • Adolescent Satisfaction with Care

    1 day

  • Interval Receipt of Care

    3 months

  • Motivation for Health Behavior Change

    1 day

  • Specific Health Risk Behavior Change

    3 months

Other Outcomes (2)

  • Adolescent Perceived Support from their Primary Care Provider

    1 day

  • Adolescent Health Self-Efficacy

    1 day

Study Arms (2)

Check Yourself App With Feedback

EXPERIMENTAL

Adolescents complete Check Yourself, an electronic health screening app and receive personalized, motivational feedback on their health behaviors prior to their primary care appointment. Key components of Check Yourself include the provision of age normative feedback, goal setting strategies, and strategies to highlight discrepancies. Primary care providers receive a summary report of health risk behaviors from Check Yourself prior to their adolescent patient's primary care appointment.

Behavioral: Check Yourself App with Feedback

Usual Care

NO INTERVENTION

Participants are asked to complete health risk screening on a tablet computer. No personalized feedback is provided to adolescents and primary care providers do not receive a summary report of the adolescent's health risk behaviors.

Interventions

Check Yourself App With Feedback

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Eligible individuals will be 13-18 years old who have an appointment to see a provider at a participating clinic and will be able to read and comprehend English.

You may not qualify if:

  • Individuals will be excluded from the study if:
  • they do not meet age requirements,
  • do not have an appointment at a participating clinic,
  • lack the means to complete follow-up interviews (i.e., has neither telephone not internet access),
  • have a sibling who has/is being enrolled in the study and/or
  • are not able to read or comprehend English.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Related Publications (1)

  • Richardson LP, Zhou C, Gersh E, Spielvogle H, Taylor JA, McCarty CA. Effect of Electronic Screening With Personalized Feedback on Adolescent Health Risk Behaviors in a Primary Care Setting: A Randomized Clinical Trial. JAMA Netw Open. 2019 May 3;2(5):e193581. doi: 10.1001/jamanetworkopen.2019.3581.

MeSH Terms

Conditions

Health Risk Behaviors

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Laura P Richardson, MD MPH

    Seattle Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Pediatrics, University of Washington and Investigator, Seattle Children's Research Institute

Study Record Dates

First Submitted

February 5, 2015

First Posted

February 10, 2015

Study Start

February 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

April 18, 2018

Record last verified: 2018-04

Locations