title: Automated Adherence Reminders for High Risk Children With Asthma: A Research Protocol.
abstract: BACKGROUND
  The use of inhaled corticosteroid (ICS) medications has been shown to improve asthma control and reduce asthma-related morbidity and mortality. Two recent randomized trials demonstrated dramatic improvements in ICS adherence by monitoring adherence with electronic sensors and providing automated reminders to participants to take their ICS medications. Given their lower levels of adherence and higher levels of asthma-related emergency department (ED) visits, hospitalizations, and death, urban minority populations could potentially benefit greatly from these types of interventions.
  
  
  OBJECTIVE
  The principal objective of this study will be to evaluate the feasibility, acceptability, and limited efficacy of a text message (short message service, SMS) reminder intervention to enhance ICS adherence in an urban minority population of children with asthma. We will also assess trajectories of ICS adherence in the 2 months following asthma hospitalization.
  
  
  METHODS
  Participants will include 40 children aged 2-13 years, who are currently admitted to the Children's Hospital of Philadelphia (CHOP) for asthma, and their parent or legal guardian. Participants will be assigned to intervention and control arms using a 1:1 randomization scheme. The intervention arm will receive daily text message reminders for a 30-day intervention phase following hospitalization. This will be followed by a 30-day follow-up phase, in which all participants may choose whether or not to receive the text messages. Feasibility will be assessed by measuring (1) retention of the participants through the study phases and (2) perceived usefulness, acceptability, and preferences regarding the intervention components. Limited efficacy outcomes will include percent adherence to prescribed ICS regimen measured using Propeller Health sensors and change in parent-reported asthma control. We will perform an exploratory analysis to assess for discrete trajectories of adherence using group-based trajectory modeling (GBTM).
  
  
  RESULTS
  Study enrollment began in December 2015 and the intervention and follow-up phases are ongoing. Results of the data analysis are expected to be available by December 2016.
  
  
  CONCLUSIONS
  This study will add to the literature by providing foundational feasibility data on which elements of a mobile health text-message reminder intervention may need to be modified to suit the needs and constraints of high-risk urban minority populations.
  
  
  BACKGROUND
  Clinicaltrials.gov NCT02615743; https://www.clinicaltrials.gov/ct2/show/study/NCT02615743 (Archived with WebCite at http://www.webcitation.org/6ji59rAXN).
authors.affiliation: The Children's Hospital of Philadelphia, PolicyLab and Center for Pediatric Clinical Effectiveness, Philadelphia, PA, United States.
authors.forename: Sarah A
authors.identifier: http://orcid.org/0000-0001-6625-1644
authors.initials: SA
authors.lastname: Adams
authors.affiliation: Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, PA, United States.
authors.forename: Michelle Chan
authors.identifier: http://orcid.org/0000-0002-1728-149X
authors.initials: MC
authors.lastname: Leach
authors.affiliation: The Children's Hospital of Philadelphia, PolicyLab and Center for Pediatric Clinical Effectiveness, Philadelphia, PA, United States.|Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States.
authors.forename: Chris
authors.identifier: http://orcid.org/0000-0002-5879-0434
authors.initials: C
authors.lastname: Feudtner
authors.affiliation: Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States.|The Children's Hospital of Philadelphia, Philadelphia, PA, United States.
authors.forename: Victoria A
authors.identifier: http://orcid.org/0000-0003-2425-3427
authors.initials: VA
authors.lastname: Miller
authors.affiliation: The Children's Hospital of Philadelphia, PolicyLab and Center for Pediatric Clinical Effectiveness, Philadelphia, PA, United States.|Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States.
authors.forename: Chén Collin
authors.identifier: http://orcid.org/0000-0003-1976-0109
authors.initials: CC
authors.lastname: Kenyon
keywords: adolescent; asthma; child; child, preschool; clinical protocols; medication adherence; metered dose inhalers; pediatrics; pilot projects; randomized controlled trial; text messaging