Technology-Assisted Stepped Care Study
Condition: Asthma
Study type: Interventional

Summary: 
      The overall goal of this project is to demonstrate the feasibility, implementation, and
      preliminary efficacy of a technology-assisted stepped care (TASC) adherence-promotion
      intervention in adolescents with asthma. This is the third phase (Phase 3) of a three-phase
      project to test the preliminary efficacy of a technology-assisted stepped care (TASC)
      intervention. In Phase 1, we developed the intervention using patient and provider feedback
      from focus groups. In Phase 2 we refined the developed intervention by having five
      adolescents from the focus groups test the intervention for feasibility. In this third phase,
      we will enroll up to 50 adolescents to pilot-test the refined intervention for preliminary
      efficacy.
    

Detailed description: 
      Up to fifty adolescents with asthma will be enrolled in an open label pilot trial of the TASC
      adherence-promotion intervention for a duration of twelve months. First, participants will
      complete baseline questionnaires related to demographic, and clinical predictors of adherence
      and asthma and a 4 week run-in phase to assess baseline adherence using electronic inhaler
      monitoring with a cellphone that is provided to them. Following the run-in period, all
      participants will receive Step 1 of the TASC intervention for a minimum of 4 weeks. Step 1
      (Information) will include electronic educational information related to asthma symptoms and
      triggers, attacks, self-monitoring, treatments, action plans, and automated text message
      medication reminders. Following the initial four weeks of Step 1, adherence will be evaluated
      and a rate of less than 68% will serve as the cause for "stepping up" to the next level of
      the intervention. Adherence checks will continue to occur every four weeks for the duration
      of the study and adherence <68% will prompt movement from one level of treatment to the next.
      Participants may remain at a treatment level for more than four weeks and may complete 1, 2,
      or 3 interventions steps during the 5 month study depending on the adolescent's adherence.
      Step 2 (Motivation) will include electronic monitoring of adherence and personally tailored
      feedback via text messages. Adolescents will be given access to the adherence tracking
      cellphone app and graphs of their inhaler adherence. Adolescents will also receive brief,
      personalized text messages that provide supportive motivation and directive, tangible
      actions. Step 3 (Behavioral) will include problem-solving telehealth intervention with a
      trained clinician. Four telehealth sessions individually tailored to the unique needs and
      barriers of the adolescent will be provided. The primary outcome measure will be
      electronically-monitored adherence assessed at post-treatment. Secondary outcomes include
      asthma severity as well as process evaluation questions and quantitative measures of
      feasibility, acceptability, and satisfaction to demonstrate implementation. Participants will
      remain in the study for an additional 7 months after they complete month 5 of the study. For
      the remaining 7 months, participants will be randomized to one of two booster session
      patterns with the goal to improve inhaler adherence. The statistician will make the
      randomization schedule and the principle investigator will maintain the randomization
      schedule. Two different booster patterns are being used to test which pattern will be most
      effective. The first booster session pattern will include booster sessions at the end of
      month 6, 8, and 12. The second booster session pattern will include booster sessions at the
      end of month 6, 7, 8, 10, and 12. Booster sessions will review content provided during the
      intervention and the intervention delivery method will be consistent with the participants
      final intervention step. Participants will also continue to complete monthly check-ins with
      the study coordinator to complete the Composite Asthma Severity Index, the Asthma Control
      Test, and a spirometry test.
    

Intervention name(s): Technology-assisted Stepped-care
Intervention type(s): Behavioral
Intervention description(s): Step 1 of the intervention includes educational materials related to asthma. Step 2 includes electronic monitoring of adherence and a text messaging intervention personally tailored to the participant. Step 3 includes problem solving telehealth sessions with a trained clinician.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research