Mobile Technology & Online Tools to Track Adherence in Chronic Illness Patients
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus, Type 1; Chronic Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this project is to test the efficacy of Planet T1D, a mobile and web-based
      technology infrastructure specifically designed to (a) enhance youths' type 1 diabetes
      disease- and treatment-related knowledge through interactive and game-based educational
      materials; (b) support adherence to the treatment regimen through customized task prompts via
      mobile and web-based delivery; and (c) promote patient-provider communication through
      real-world data collection and feedback loops. Investigators will examine the effectiveness
      of the Planet T1D mobile app and website in improving treatment adherence, disease-related
      knowledge, transition readiness, condition management, and the psychological correlates of
      these variables in youth with type 1 diabetes.
    

Detailed description: 
      Advances in medical treatment options over the past several decades have translated into
      substantially higher survival rates for those who suffer with chronic illness. Consequently,
      the prevalence of chronic illness has risen significantly in recent years, such that one out
      of every four youth in the United States currently lives with a chronic illness. The health
      and well-being of these youth is directly impacted by the degree to which they adhere to
      their treatment regimen. However, treatment regimens for chronic illness can be highly
      complex, making adherence problematic, particularly when combined with deficits in memory and
      executive functioning concomitant with many chronic illnesses. Adherence also tends to
      deteriorate over time; the youth's motivation or commitment to treatment may decline as
      symptoms improve or negative side effects occur. With low adherence comes worsening symptoms
      and significantly greater risk for serious medical complications and mortality in young
      adulthood. The costs associated with low adherence, such as the need for additional care, are
      also substantial both for the patient and society.

      While a number of factors have been found to impact treatment adherence, risk for
      non-adherence-across varied forms of chronic illness-is markedly elevated when the youth
      lacks disease- and treatment-related knowledge and when parents provide little supervision
      for carrying out regimen tasks. With nearly 90% of youth with chronic illness expected to
      survive and therefore transition from pediatric care into adult-focused healthcare systems,
      it is critically important to empower youth to take ownership of their own healthcare. To do
      so, we need to provide accessible, affordable tools that can effectively increase patients'
      skills and knowledge for managing their illness and support on-going adherence to their
      treatment regimen.

      The purpose of this project is to test the efficacy of Planet T1D, a mobile and web-based
      technology infrastructure specifically designed to (a) enhance youths' type 1 diabetes
      disease- and treatment-related knowledge through interactive and game-based educational
      materials; (b) support adherence to the treatment regimen through customized task prompts via
      mobile and web-based delivery; and (c) promote patient-provider communication through
      real-world data collection and feedback loops. Investigators will examine the effectiveness
      of the Planet T1D mobile app and website in improving treatment adherence, disease-related
      knowledge, transition readiness, condition management, and the psychological correlates of
      these variables in youth with type 1 diabetes.

      All participants will complete study measures at pre- and post-assessment time points. In
      total, participants will take part in this study for approximately 2 months from pre- to
      post-assessment. Families will be recruited to participate in either the treatment condition
      or the control group. Families in the treatment condition will receive the Planet T1D app and
      access to the associated website for the full duration of the study (2 months) between
      pre-test and post-test. Families in the control group will not receive access to the app and
      website, but instead will be asked to complete a series of online questionnaires at each of
      the two data collection time points (pre-test, post-test).

      Investigators hypothesize that greater use (i.e., dosage) and prolonged use of Planet T1D and
      access to the associated website will: increase disease-related knowledge, treatment
      adherence, self-efficacy for management of type 1 diabetes, current type 1 diabetes
      self-management behaviors, readiness to transition to independent self-care, and perceived
      benefits of type 1 diabetes treatment, while also decreasing perceived barriers to type 1
      diabetes treatment. Moreover, investigators believe that improvement of these outcomes
      through use of Planet T1D will result in more positive mental health outcomes for patients,
      including higher reported quality of life. Investigators expect that those in the treatment
      condition will have better outcomes than those in the control group on all of these measures
      at both midpoint and post-assessment time points. Finally, investigators expect all
      participants to report high usability, quality, and value of the Planet T1D mobile app and
      website and to positively rate their experience with Planet T1D.
    

Intervention name(s): Planet T1D
Intervention type(s): Behavioral
Intervention description(s): Planet T1D is a mobile and web-based technology infrastructure specifically designed to (a) enhance youths' type 1 diabetes disease- and treatment-related knowledge through interactive and game-based educational materials; (b) support adherence to the treatment regimen through customized task prompts via mobile and web-based delivery; and (c) promote patient-provider communication through real-world data collection and feedback loops.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Type 1 Diabetes; Adolescents; T1D