Cell Phone Support to Promote Medication Adherence Among Adolescents and Young Adults With Chronic Illness
Condition: Medication Adherence
MeSH terms: Chronic Disease
Study type: Interventional

Summary: 
      Background: Adolescents and young adults (AYAs) with chronic illnesses often struggle to
      develop illness self-management skills. Mobile health (mHealth) interventions have been
      developed for some specific chronic illnesses, but flexible interventions that can be
      generalized across conditions are needed to accelerate translation.

      Research Hypotheses: 1) Cell phone support (CPS) will increase medication adherence and
      self-management skills across a variety of health conditions; 2) CPS delivered by text
      message will outperform CPS delivered by phone calls; 3) Patients' perceptions of the human
      adherence facilitator (AF) will differ based on the mode of communication, text message
      versus phone calls.

      Design: A randomized, controlled, 3-arm pilot trial, following community-based participatory
      research (CBPR) principles, will test the impact of AF delivered by phone calls or text
      messages on medication adherence and illness self-management. Conditions will be CPS
      delivered by phone calls, CPS delivered by text messages, or usual care.

      Participants: Participants will include AYAs with diverse chronic illnesses aged 15-20 years
      (N = 60).

      Methods: This study will involve piloting CPS via different communication modes in a
      randomized trial, informed by CBPR principles. Questionnaires and focus groups will be used
      to understand how patients perceive the intervention and adherence facilitator.

      Main Outcome Measures: Outcomes will include medication and appointment adherence, pharmacy
      refill ratios, self-management skills, and perceptions of the AF.

      Innovation: This study will provide new knowledge regarding how to promote illness
      self-management skills, and may result in an mHealth intervention with the potential to
      widely impact supportive care for AYAs with chronic illnesses.
    

Detailed description: 
      The aim of this randomized pilot trial is to evaluate the acceptability, feasibility, and
      efficacy of CPS delivered by phone calls or text messages to AYAs with two distinct chronic
      illnesses, in preparation for an R01 proposal to conduct a multisite,
      effectiveness-implementation hybrid trial. We propose 1) assessing the feasibility,
      acceptability, and efficacy of CPS for improving medication adherence, 2) investigating the
      impact of delivering CPS through live text messages versus phone calls using quantitative and
      qualitative methods, and 3) evaluating patient and provider views of CPS to guide future
      implementation work. The proposed research follows the conceptual model, illustrated below,
      positing that CPS will promote adherence through engaging AYAs in calls or texts with a human
      AF providing social support. We predict that delivering CPS by text message will increase
      feasibility and acceptability, perceived social support, and adherence compared to voice
      delivery.
    

Intervention name(s): Cell Phone Support
Intervention type(s): Behavioral
Intervention description(s): Cell Phone Support includes short phone calls (<5 minutes) made each weekday by a human AF to provide social support, medication reminders, problem-solving coaching, incentives for answering calls, and referrals to other services. Cell Phone Support calls focus on assisting AYAs in identifying and accessing resources and support from their natural environments, such as finding ways they can receive needed help from their families, peers, medical teams, and communities. Live Text Support will deliver the same intervention, by text message.
Other intervention name(s): Live Text Support
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: We will randomly assign participants to cell phone support by voice, cell phone support by text message, or automated text reminders.
Masking: None (Open Label)
Primary purpose: Treatment