steps to help improve Time 2 Focus. Results will include descriptive analysis of survey data and thematic analysis of interview content.

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Determining the Value of a Skill-Based Mobile Application for Patients With Type 2 Diabetes:A

Feasibility Study Protocol With Patients and Providers in a Healthcare Setting

Jessica Brueggeman, Rob Peters, Neala Havener Connected Health Symposium 2015

www.iproc.org/2015/1/e10

DOI: http://doi.org/10.2196/iproc.4694

Abstract

Background:

More than 29 million people in the United States live with diabetes. It is imperative to find solutions that empower and help patients build skills to better self-manage their disease independently in their daily lives [1].MicroMass Communications, Inc., has completed a preliminary usability test of Time 2 Focus, a type 2 diabetes mobile application (app), and made revisions to the app to meet the needs of patients. MicroMasswill conduct a study to determine the acceptability and feasibility of Time 2 Focus. The app incorporates evidence-based behavioral techniques and leverages gamification principles to drive patients’ self-management behaviors. The experience guides patients through progressive skill-building activities related to real-world situations. Unlike current mobile apps for type 2 diabetes, Time 2 Focus goes beyond simple tracking and patient education. The app aims to improve patients’ confidence in their ability to carry out tasks, build problem-solving skills, and make better decisions—ultimately leading to better clinical outcomes.

Objectives:

To determine the acceptability and feasibility of the mobile app on a larger scale, MicroMass intends to conduct a study in partnership with a community-based health system. The study aims to determine whether a mobile app to improve problem-solving skills is acceptable to patients and healthcare providers and whether integrating the app into the process of care is feasible.

Methods:

MicroMass will conduct a survey of 180 patients to determine the perceived acceptability of the app. MicroMass will recruit 6 to 10patients and 8 to 12 healthcare providers to participate in in-depth interviews to gather feedback and determine how Time 2 Focus can be implemented into the process of care.

Results:

MicroMass will analyze the results from patient surveys and from patient and provider interviews to direct next steps to help improve Time 2 Focus. Results will include descriptive analysis of survey data and thematic analysis of interview content.

Conclusions:

The purpose of this feasibility study is to determine whether patients and providers feel that Time 2 Focus would help develop self-management skills and engage patients beyond traditional tracking apps. Based on the findings of the feasibility study, MicroMass will take steps to improve Time 2 Focus. In the future, MicroMass plans to conduct a randomized controlled trial to assess the clinical impact of Time 2 Focus compared to that of standard diabetes education. If Time 2 Focus is proven effective, MicroMass intends to make the app commercially available to health systems as a cost-effective, scalable, and wide-reaching solution to improve clinical outcomes.

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Introduction

Situation

More than 29 million people in the United States live with diabetes [1]. Managing diabetes requires interventions beyond interaction with a healthcare provider. From 2007 to 2010, 47.5% of patients with diabetes did not meet an HbA1c target of 7.0% or less [2]. From 2007 to 2010, 75% of patients with diabetes reported that they tried to lose weight, and 57% tried to increase physical activity [2]. Research shows that medication is only one avenue to help patients reach clinical goals [2]. The behavioral components of diabetes self-care, including dietary changes, increased physical activity, and medication adherence, require patients to have the skills to successfully self-manage to meet and sustain their goals in the face of daily challenges [3,4].

Type 2 Diabetes Mobile App Development

MicroMass worked with type 2 diabetes patients and a certified diabetes educator to ensure that Time 2 Focus addressed the real-world needs of patients and complemented their medical care. Time 2 Focus is empirically based and leverages gamification principles that engage patients and drive intrinsic motivation to learn progressively difficult skills [5].

MicroMass reviewed the published literature to uncover the drivers of optimal self-management and successful behavior change interventions in patients with type 2 diabetes. From this review, problem solving, illness perceptions, goal setting, and feedback and reinforcement emerged as critical strategies to build patient skills in an effort to improve clinical outcomes (Table 1).

Problem solving requires patients to identify real-world challenges, generate options, implement solutions, and evaluate the results [6]. Illness perceptions are an accurate understanding of type 2 diabetes and the impact of behavior on management of their condition [7]. Goal setting encourages patients to apply what they’ve learned and focus their

attention on a specific task to set targeted, incremental health objectives that are achievable, realistic, and personal [8]. Feedback and reinforcement for completion of gamified challenges within the app encourage positive changes in patient behavior [5].

Preliminary Usability Research

Preliminary usability testing of Time 2 Focus was conducted with a convenience sample of participants recruited from employer groups. Participants were provided with a prototype of the app loaded onto mobile devices. Participants progressed through the application and provided feedback on their experience via survey.

There were limitations in recruitment. The employer groups did not have access to a large sample pool of individuals who had been diagnosed with type 2 diabetes and who met the study criteria.

The results from this test indicated that patients found the app to be valuable in managing their diabetes and yielded useful feedback for ongoing development. MicroMass has made updates to the existing prototype based on this feedback.

Audience

MicroMass will collaborate with a community-based health system to recruit patients and providers. The diabetes prevalence rate in this patient population is 17.2% [9], greatly exceeding the rates for North Carolina (10.2%) and the nation (9.8%) [1,10].

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Market Analysis

Research has shown that interventions using evidence-based strategies improve clinical outcomes [4,11,12]. Diabetes mobile apps currently on the market largely address functional needs such as tracking medication, physical activity, and dietary choices [13]. In a 2013 analysis of 227 diabetes mobile apps available to consumers, only two included problem solving as defined by the American Association of Diabetes Educators (AADE) [13]. The AADE identifies problem solving as one of the critical self-care behaviors [11].

Research demonstrates that healthcare providers lack the time and skills to counsel patients about how to change their behavior and improve their self-management skills [14]. In addition, providers and patients are often unable to judge the potential effectiveness of an app because there is limited or no research demonstrating its effectiveness [13].

Objectives

This study aims to test the feasibility of Time 2 Focus. From this study, MicroMass hopes to gain concrete

recommendations on to how to optimize the app to increase type 2 diabetes self-management and ultimately to improve patient outcomes. This research is innovative and will advance current scientific knowledge in three areas.

Expand Current Research

A meta-analysis of mobile phone interventions demonstrates that mobile is a viable channel to impact outcomes in patients with type 2 diabetes [15]. This research will answer the following questions regarding the feasibility and acceptability of Time 2 Focus:

 Do patients see value in using the app to gain diabetes self-management skills?  Do patients feel the gamified components of the app are motivating?

 Do patients intend to engage in learning diabetes self-management skills outside of the clinical setting?  Do patients feel this app would be engaging beyond tracking?

 Do providers see value in offering skill-building exercises available in the app to patients?  How can providers integrate the app into their existing process of care?

Change the way diabetes care is delivered

There are only 20,000 diabetes educators in the United States [16] and 29 million patients with diabetes [1]. Technology-based interventions provide a lower-cost approach to supplement traditional care [17].Time 2 Focusmay extend the impact of existing education from healthcare providers and fill the gap in areas where patients have limited access to education.

Establish a new standard for patient education in type 2 diabetes: gamification and real-world skill-building

Knowledge is one important element in helping patients improve self-management of type 2 diabetes, but knowledge alone is not enough. Patients also need skills and confidence to effectively sustain self-management behaviors (Figure 1) [18,19].Thousands of educational mobile apps are available for patients. However, many lack evidence-based practices, provide only tracking components, are not interactive, and lack opportunities to solve for real-world problems [16].

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4 Figure 1. Patient Skill-Building Exercises. Game, article, and Food Comparison tool designed to help the patient build skills.

Methods

Study Design

MicroMass will be conducting quantitative and qualitative research. Six-hundred patients with type 2 diabetes will be invited to participate in a brief survey by our partner healthcare system. The survey will contain questions regarding mobile app usage, willingness to use an app, barriers to management, helpful aspects of a mobile app to improve self-management, and type 2 diabetes education. Validated survey scales from published literature will be utilized when possible.

MicroMass will conduct in-depth interviews with 6 to 10 patients and 8 to 12 healthcare providers employed by the health system. Participants will be asked to interact with Time 2 Focus on mobile devices during the interviews and to provide feedback on their experience.

Participants and Recruitment

MicroMass will recruit a random, representative sample of the health system’s type 2 diabetes patient population to complete the survey. From these patients, MicroMass will recruit 6 to 10 patients to participate in interviews. To recruit for at least 8 to 12 interviews with healthcare providers, MicroMass will attend an employee meeting and provide an overview of Time 2 Focus. At this meeting, healthcare providers will be invited to participate in interviews.

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Statistical Analysis

Survey data will be analyzed using SPSS software to determine descriptive analysis and correlations between variables. We aim to get a response rate of 30%, or 180 patients, to complete the quantitative survey.

MicroMass will videotape all interviews with patients and healthcare providers. MicroMass will conduct a thematic analysis of these interviews from the recordings and notes taken. MicroMass will identify and code all videos according to identified themes.

Results

Results from the survey and in-depth interviews with patients will determine the acceptability of Time 2 Focus. After identifying the barriers and assessing the acceptability of a mobile app for self-management from the patient

perspective, Time 2 Focus will be updated. Results from the thematic analysis of healthcare provider interviews will direct how Time 2 Focus may be integrated into the existing process of care and provide insight into how this app can be

implemented in the commercial space for health systems.

Discussion

Limitations

One anticipated limitation of this research is the small sample size for the qualitative interviews with patients and healthcare providers. The results from these interviews will not represent the perceptions and needs of all type 2 diabetes patients and their providers, but rather are meant to provide direction for future optimization.

Future Work

MicroMass plans to conduct this feasibility study in 2016. Based on the results, MicroMass intends to conduct a randomized controlled trial with patients and healthcare providers to determine the impact of Time 2 Focus on clinical outcomes and the cost-effectiveness of the app compared to traditional diabetes education.

Conclusions

Time 2 Focus was developed with the intent of offering a mobile, skill-based solution as a new standard in diabetes education. Results from this feasibility study will determine whether patients and providers view Time 2 Focus as a valuable intervention to build skills for type 2 diabetes self-management as well as next steps to integrate Time 2 Focus into existing processes of care.

Future research will determine whether Time 2 Focus can complement, extend the impact, and fill the gap for patients with limited access to diabetes educators. Moreover, future research can provide evidence to support the use of Time 2 Focus to build self-management skills beyond what is currently available to patients in the clinical setting and in existing apps. Leveraging existing Electronic Health Record technology with mobile interventions can lead to a greater connection between patients and their healthcare team—a key component of integrated care [17].

MicroMass ultimately aims to show that Time 2 Focus can be commercially viable as a solution to drive down healthcare costs and improve patient engagement in care, resulting in improved clinical outcomes.

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Acknowledgments

MicroMass has applied for funding for this feasibility study from the National Institutes of Health, Small Business Innovation Research grant program.

Conflicts of Interest

None declared.

Abbreviations

AADE, American Association of Diabetes Educators; app, application.

Table 1. Time 2 Focus learning objectives and behavioral approaches.

Level: Title and Components

Learning Objectives

Behavioral Approaches

a

1: Time 2 Focus Basics 10 articles | 3 videos | 1game 1 survey | 1 text message |1e-mail

Explain the roles of insulin and blood glucose in the body.

Illness Perceptions

2: Focus on Carbs

8 articles | 1 video | 3games 1 survey | 1 text message |1e-mail

Set a foundation. Learn to understand carbohydrates and the impact on type 2 diabetes management.

Illness Perceptions | Goal Setting | Participatory Learning

3: Focus on Physical Activity 9 articles | 1 video | 2games

1 survey | 1 text message | 1e-mail

Explain the effect of physical activity on blood glucose in type 2diabetes.

4. Focus on Monitoring 10 articles | 2 videos | 2games 1 survey | 1 text message | 1e-mail

Understand the connection between self-monitoring and the impact of physical activity on blood glucose.

5. Mastery Challenge1 2 articles | 5 games | 1survey

6 text messages | 1e-mail

Assess knowledge and comprehension of key concepts, including type 2 diabetes, insulin, and bloodglucose.

Illness Perceptions | Goal Setting | Participatory Learning | Feedback andReinforcement

6. Focus on Carb Planning 9 articles | 1 video | 2games

1 survey | 3 text messages | 1e-mail

Learn to plan ahead for total carbs for meals and snacks in a real-world situation.

Illness Perceptions | Goal Setting | Participatory Learning | Feedback and Reinforcement | Problem Solving

7. Focus on Making Choices 10 articles | 1 video | 2games 1 survey | 3 text messages | 1e-mail

Develop skills to identify proteins and serving sizes, and equip patients with tools to make informed decisions.

Illness Perceptions | Goal Setting | Participatory Learning | Feedback and Reinforcement | Problem Solving 8. Focus on Day-to-day Decisions

10 articles | 1 video | 2games 1 survey | 3 text messages | 1e-mail

Develop strategies for planning ahead for carb decisions, physical activity, and self-monitoring.

Illness Perceptions | Goal Setting | Participatory Learning | Feedback and Reinforcement | Problem Solving

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7 9. Decisions Away From Home

7 articles | 1 game | 1survey 2 text messages | 1e-mail

Engage in problem-solving strategies to plan and make decisions away from home.

Illness Perceptions | Goal Setting | Participatory Learning | Feedback and Reinforcement| Problem Solving

10. Mastery Challenge2 2 articles | 6 game | 1survey 7 text messages | 1e-mail

Assess knowledge and comprehension of key topics, including carbohydrates, physical activity, and self-monitoring.

7 articles | 1 video | 1survey 1 text message | 1e-mail

Establish habits, encourage decision making, and facilitate goal setting and habit formation in managing type 2 diabetes.

12: Focus on the Future 7 articles | 1 video | 1survey 1 text message | 1e-mail

Patient motivation to engage in healthy behavior and self-management of type 2 diabetes in the future.

a_{Time 2 Focus is designed for patients to learn skills as they progress throughout the gamified levels. Each level builds on the behavioral drivers} addressed in the previous level. The italicized content reflects the specific behavioral approach for that level.

Multimedia Appendix 1

http://www.micromass.com/digital-health-awards-time-2-focus/

MicroMass’ Time 2 Focus website originally submitted for an award entry. Within this website, visitors can read about the rationale for developing Time 2 Focus and components of the Time 2 Focus app.

http://www.micromass.com/time2focusdemo/

Time 2 Focus demonstration website designed to showcase the evidence-based foundation for the Time 2 Focus app: Improve patient outcomes and to provide a unique user experience.

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