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Check Yourself v2.0

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ClinicalTrials.gov Identifier: NCT02882919
Recruitment Status : Active, not recruiting
First Posted : August 30, 2016
Last Update Posted : April 26, 2018
Sponsor:
Information provided by (Responsible Party):
Carolyn McCarty, Seattle Children's Hospital

Brief Summary:
Health risk screening in adolescent primary care is infrequently performed and results are rarely followed by targeted intervention. In response to the need for screening-linked interventions, the study team has developed and optimized a web-based, electronic Personalized Motivational Feedback tool referred to as "Check Yourself v2.0" Based on motivational interviewing, a technique to mobilize personal change, Check Yourself is designed to promote healthy choices for the multiple behaviors relevant to adolescents.

Condition or disease Intervention/treatment Phase
Adolescent Behavior Behavioral: Check Yourself v2.0 Not Applicable

Detailed Description:
The proposed study is a randomized controlled trial that compares the effectiveness of Check Yourself v2.0 to usual care. The purpose of this study is to determine the impact of Check Yourself on reducing health risk behaviors and improving quality of care among adolescents receiving primary health care services relative to usual care.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: Improving Teen Health With Health Information Technology
Study Start Date : October 2016
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : August 2018

Arm Intervention/treatment
Experimental: Check Yourself v2.0
In the intervention group, adolescents complete Check Yourself which delivers 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 will receive a summary report of health risk behaviors prior to their adolescent patient's primary care appointment.
Behavioral: Check Yourself v2.0
In the intervention group, adolescents complete Check Yourself which delivers 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 increase motivation for healthy behaviors. Primary care providers will receive a summary report of health risk behaviors prior to their adolescent patient's primary care appointment.

No Intervention: Usual care
In the usual care group, patients are asked to complete health risk screening on a 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



Primary Outcome Measures :
  1. Number of Health risk behaviors [ Time Frame: 3 months ]
    Total count adolescent health-risk behaviors at 3-month follow-up. Risk behaviors include: during typical day: ≥2 sugar-sweetened beverages consumed and ≤3 servings fruits/vegetables consumed; ≤3 days with 60+ minutes exercise during typical week; having texted while driving in past 3 months; ≤7 hours of sleep during typical night; not "always" using seatbelt; not "always" using helmet when bicycling; having driven under the influence of substances; tobacco use; days of alcohol consumption in last 30 days (risk based on age) and/or number of drinks per drinking episode (risk based on age and gender); days of marijuana consumption in 30 days (risk based on age) and/or other drug use in past 3 months; not using birth control during last sexual intercourse and/or not "always" using a condom; and score of ≥10 on PHQ-9.

  2. Sweetened Beverage Consumption [ Time Frame: 3 months ]
    Adolescent self-reported sweetened beverages consumed in a typical day in past 3 months

  3. Physical Activity [ Time Frame: 3 month ]
    Adolescent self-reported days with >60 minutes of physical activity in an average week in past 3 months

  4. Sleep [ Time Frame: 3 month ]
    Adolescent self-reported hours of sleep on a typical night in past 3 months

  5. Alcohol Consumption [ Time Frame: 3 month ]
    Adolescent self-reported number of days of alcohol consumption and number of drinks during a typical drinking episode in the prior month

  6. Marijuana and/or Other Drug Consumption [ Time Frame: 3 month ]
    Adolescent self-reported number of days using marijuana in the past month and/or other drugs used in past 3 months

  7. Depression [ Time Frame: 3 month ]
    Adolescent self-reported depression as measured on the nine item Patient Health Questionnaire in past 2 weeks

  8. Seat belt Use [ Time Frame: 3 month ]
    Adolescent self-reported frequency of seat belt use in a car in past 3 months

  9. Helmet Use [ Time Frame: 3 month ]
    Adolescent self-reported frequency of helmet use while bicycling in past 3 months

  10. Texting while driving [ Time Frame: 3 month ]
    Adolescent self-reported endorsement of texting while driving in past 3 months

  11. Condom Use and/or Birth Control Use [ Time Frame: 3 month ]
    Adolescent self-reported condom use with sexual intercourse in past 3 months and/or use of birth control with last sexual intercourse

  12. Driving with Alcohol Impairment [ Time Frame: 3 month ]
    Adolescent self-reported driving under the influence of a substance in past 3 months

  13. Fruit and Vegetable Consumption [ Time Frame: 3 month ]
    Adolescent self-reported fruits and vegetables consumed in a typical day in past 3 months

  14. Number of risk behaviors counseled on during primary care appointment [ Time Frame: 1 day ]
    Number of adolescent reported health risk behaviors discussed with the healthcare provider during the primary care visit adjusted for the total number of health risk behaviors reported at baseline

  15. Adolescent Satisfaction with Care [ Time Frame: 1 day ]
    Adolescent satisfaction with care will be assessed using 1 item adapted from the consumer Assessment Of healthcare Providers and Systems (CAHPS) measure at 1 day follow up

  16. Tobacco Use [ Time Frame: 3 month ]
    Adolescent self-reported endorsement of tobacco use in past 3 months


Secondary Outcome Measures :
  1. Number of Health risk behaviors [ Time Frame: 6 months ]
    Total count adolescent health-risk behaviors at 6 month follow-up. Risk behaviors include: during typical day: ≥2 sugar-sweetened beverages consumed and ≤3 servings fruits/vegetables consumed; ≤3 days with 60+ minutes exercise during typical week; having texted while driving in past 3 months; ≤7 hours of sleep during typical night; not "always" using seatbelt; not "always" using helmet when bicycling; having driven under the influence of substances; tobacco use; days of alcohol consumption in last 30 days (risk based on age) and/or number of drinks per drinking episode (risk based on age and gender); days of marijuana consumption in 30 days (risk based on age) and/or other drug use in past 3 months; not using birth control during last sexual intercourse and/or not "always" using a condom; and score of ≥10 on PHQ-9.

  2. Sweetened Beverage Consumption [ Time Frame: 6 month ]
    Adolescent self-reported sweetened beverages consumed in a typical day in past 3 months

  3. Fruit and Vegetable Consumption [ Time Frame: 6 month ]
    Adolescent self-reported fruits and vegetables consumed in a typical day in past 3 months

  4. Physical Activity [ Time Frame: 6 month ]
    Adolescent self-reported days with >60 minutes of physical activity in an average week in past 3 months

  5. Sleep [ Time Frame: 6 month ]
    Adolescent self-reported hours of sleep on a typical night in past 3 months

  6. Alcohol Consumption [ Time Frame: 6 month ]
    Adolescent self-reported number of days of alcohol consumption and number of drinks during a typical drinking episode in the prior month

  7. Marijuana and/or Other Drug Consumption [ Time Frame: 6 month ]
    Adolescent self-reported number of days using marijuana in the past month and/or other drugs used in past 3 months

  8. Depression [ Time Frame: 6 month ]
    Adolescent self-reported depression as measured on the nine item Patient Health Questionnaire in past 2 weeks

  9. Seat-belt Use [ Time Frame: 6 month ]
    Adolescent self-reported frequency of seatbelt use in a car in past 3 months

  10. Helmet Use [ Time Frame: 6 month ]
    Adolescent self-reported frequency of helmet use while bicycling in past 3 months

  11. Texting while driving [ Time Frame: 6 month ]
    Adolescent self-reported endorsement of texting while driving in past 3 months

  12. Condom Use and or Birth Control Use [ Time Frame: 6 month ]
    Adolescent self-reported condom use with sexual intercourse in past 3 months and/or use of birth control at last sexual intercourse

  13. Driving with Alcohol Impairment [ Time Frame: 6 month ]
    Adolescent self-reported driving under the influence of a substance in past 3 months

  14. Interval Receipt of Care [ Time Frame: 3 months ]
    Dichotomous variable indicating receipt of any follow-up care to address risk behaviors identified at baseline adjusted for baseline number of health risk behaviors

  15. Interval Receipt of Care [ Time Frame: 6 months ]
    Dichotomous variable indicating receipt of any follow-up care to address risk behaviors identified at baseline adjusted for baseline number of health risk behaviors

  16. Readiness to Change Ruler [ Time Frame: 1-day ]
    Assessment of adolescent reported motivation to change overall health

  17. Readiness to Change Ruler [ Time Frame: 3 months ]
    Assessment of adolescent reported motivation to change overall health

  18. Readiness to Change Ruler [ Time Frame: 6 months ]
    Assessment of adolescent reported motivation to change overall health

  19. Adolescent Health Self -Efficacy [ Time Frame: 1 day ]
    Self-report of adolescent health self efficacy

  20. Tobacco Use [ Time Frame: 6 month ]
    Adolescent self-reported endorsement of tobacco use in past 3 months



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Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Eligible adolescent participants will be13-18 years of age
  • Caregiver participants will be 18 years of age or older
  • Able to understand English.
  • Will have an appointment (or have a child with an appointment) with a participating medical practice.

Exclusion Criteria: Adolescents will be excluded from the study

  • Participants do not meet age requirements
  • Do not have an appointment with a participating provider at a PSPRN clinic,
  • Lack the means to complete follow-up interviews (i.e., have neither telephone nor internet access)
  • Have a sibling who has been/is being enrolled in the study or have previously participated in our previous trial comparing Check Yourself to usual care
  • Not able to understand English.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02882919


Locations
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Carolyn McCarty

Responsible Party: Carolyn McCarty, Research Associate Professor of Pediatrics, University of Washington and Investigator, Seattle Children's Research Institute, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT02882919     History of Changes
Other Study ID Numbers: 1R01HS023383-01 ( U.S. AHRQ Grant/Contract )
First Posted: August 30, 2016    Key Record Dates
Last Update Posted: April 26, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No