What happens when you combine the participatory design research approach and a patient engagement company for a mHealth study?

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*Kevin A. Clauson, *Dana M. Lewis,*Boris Glants
PharmD, Nova Southeastern University; Swedish Medical Center; Tonic Health
← Back to Medicine X 2012 Proceedings
Panel Discussion
Sunday, Sept 30, 2012: 12:25 PM – Paul Berg (Plenary) Hall

*Presenting Speakers

Background
Medication non-adherence is a preventable, causative factor for diminished control of type 2 diabetes mellitus (T2DM). In addition to forgetfulness, factors including the level of patient engagement, cognitive status, and health literacy also play substantial roles in this $300 billion problem. However, despite observed benefits with the shared decision-making model and the established importance of health literacy, many interventions are developed to improve medication adherence without featuring these elements. The objective of this study is to use a participatory design approach, an interactive, iPad-based data collection tool, and investigate the participatory medical model within the context of delivering short message service (SMS) (i.e., text messages) to improve medication adherence in patients with T2DM.

Methods
The study is a parallel group, open-label, randomized, controlled clinical trial comprised of three arms: 1) control group receiving standard care only with no SMS, 2) unidirectional text message intervention group (uSMS), and 3) bidirectional text message intervention group (bSMS). A total of 162 participants will be followed for 6 months. The primary clinical outcome will be hemoglobin A1c (HbA1c) at 6 months. Measures of interest also include disease state knowledge (Diabetes Knowledge Test), health literacy (Rapid Estimate of Adult Health Literacy – Short Form), cognition (CLOX-1, verbal fluency), and adherence (Morisky Medication Adherence Scale). An iPad-optimized interface that takes advantages of the full range of its multimedia capacities has been developed in order to allow participants to self-administer these measures during relevant baseline, 3-month, and 6-month visits to a community pharmacy site. Additionally, patients allocated to the bSMS group will employ a modified shared decision-making model to determine the type and frequency of the text messages that they receive and respond to.

Results
Three panelists representing the voices of a patient, an entrepreneur, and an academician who collaborated on this study will discuss the elements that informed their choices in its conception, design, and implementation. Specific topics to be explored in the panel include: 1) challenges and successes with the participatory design model for patient inclusion in drafting grant and institutional review board (IRB) protocols, 2) migrating from a static series of investigator-administered scales to an engaging multimedia interface allowing for self-administration, and 3) coordination of an unconventional, but rigorous multidisciplinary mHealth study.

Conclusions
Lessons learned from this progressive collaborative research approach will be shared from the process as well as study results to date.

 

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