Technology- Assisted Stepped Care Intervention 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. Preliminary efficacy will be demonstrated by
      improved adherence to daily inhaled corticosteroids as measured by Propeller Health
      electronic monitoring devices. The TASC intervention will result in improved disease severity
      measured by the Composite Asthma Severity Index (combining dose of asthma medication
      required, asthma symptom burden, and frequency of exacerbations and health care utilization)
      and lung function as measured by mobile spirometry. The TASC adherence-promotion intervention
      implementation will be successful as evidenced by high levels of feasibility (e.g.,
      attendance), acceptability (20 item Acceptability Questionnaire), and usability (10 item
      Usability Scale).
    

Detailed description: 
      Up to thirty adolescents with asthma will be enrolled in an open label pilot trial of the
      TASC adherence-promotion intervention for a duration of five 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
      smartphone 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.
    

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