Joseph A. Cafazzo

Design of an mHealth App for the Self-management of Adolescent Type 1 Diabetes: A Pilot Study

Background The use of mHealth apps has shown improved health outcomes in adult populations with type 2 diabetes mellitus. However, this has not been shown in the adolescent type 1 population, despite their predisposition to the use of technology. We hypothesized that a more tailored approach and a strong adherence mechanism is needed for this group. Objective To design, develop, and pilot an mHealth intervention for the management of type 1 diabetes in adolescents. Methods We interviewed adolescents with type 1 diabetes and their family caregivers. Design principles were derived from a thematic analysis of the interviews. User-centered design was then used to develop the mobile app bant. In the 12-week evaluation phase, a pilot group of 20 adolescents aged 12–16 years, with a glycated hemoglobin (HbA1c) of between 8% and 10% was sampled. Each participant was supplied with the bant app running on an iPhone or iPod Touch and a LifeScan glucometer with a Bluetooth adapter for automated transfers to the app. The outcome measure was the average daily frequency of blood glucose measurement during the pilot compared with the preceding 12 weeks. Results Thematic analysis findings were the role of data collecting rather than decision making; the need for fast, discrete transactions; overcoming decision inertia; and the need for ad hoc information sharing. Design aspects of the resultant app emerged through the user-centered design process, including simple, automated transfer of glucometer readings; the use of a social community; and the concept of gamification, whereby routine behaviors and actions are rewarded in the form of iTunes music and apps. Blood glucose trend analysis was provided with immediate prompting of the participant to suggest both the cause and remedy of the adverse trend. The pilot evaluation showed that the daily average frequency of blood glucose measurement increased 50% (from 2.4 to 3.6 per day, P = .006, n = 12). A total of 161 rewards (average of 8 rewards each) were distributed to participants. Satisfaction was high, with 88% (14/16 participants) stating that they would continue to use the system. Demonstrating improvements in HbA1c will require a properly powered study of sufficient duration. Conclusions This mHealth diabetes app with the use of gamification incentives showed an improvement in the frequency of blood glucose monitoring in adolescents with type 1 diabetes. Extending this to improved health outcomes will require the incentives to be tied not only to frequency of blood glucose monitoring but also to patient actions and decision making based on those readings such that glycemic control can be improved.

Mobile Phone-Based Telemonitoring for Heart Failure Management: A Randomized Controlled Trial

Background Previous trials of telemonitoring for heart failure management have reported inconsistent results, largely due to diverse intervention and study designs. Mobile phones are becoming ubiquitous and economical, but the feasibility and efficacy of a mobile phone-based telemonitoring system have not been determined. Objective The objective of this trial was to investigate the effects of a mobile phone-based telemonitoring system on heart failure management and outcomes. Methods One hundred patients were recruited from a heart function clinic and randomized into telemonitoring and control groups. The telemonitoring group (N = 50) took daily weight and blood pressure readings and weekly single-lead ECGs, and answered daily symptom questions on a mobile phone over 6 months. Readings were automatically transmitted wirelessly to the mobile phone and then to data servers. Instructions were sent to the patients’ mobile phones and alerts to a cardiologist’s mobile phone as required. Results Baseline questionnaires were completed and returned by 94 patients, and 84 patients returned post-study questionnaires. About 70% of telemonitoring patients completed at least 80% of their possible daily readings. The change in quality of life from baseline to post-study, as measured with the Minnesota Living with Heart Failure Questionnaire, was significantly greater for the telemonitoring group compared to the control group (P = .05). A between-group analysis also found greater post-study self-care maintenance (measured with the Self-Care of Heart Failure Index) for the telemonitoring group (P = .03). Brain natriuretic peptide (BNP) levels, self-care management, and left ventricular ejection fraction (LVEF) improved significantly for both groups from baseline to post-study, but did not show a between-group difference. However, a subgroup within-group analysis using the data from the 63 patients who had attended the heart function clinic for more than 6 months revealed the telemonitoring group had significant improvements from baseline to post-study in BNP (decreased by 150 pg/mL, P = .02), LVEF (increased by 7.4%, P = .005) and self-care maintenance (increased by 7 points, P = .05) and management (increased by 14 points, P = .03), while the control group did not. No differences were found between the telemonitoring and control groups in terms of hospitalization, mortality, or emergency department visits, but the trial was underpowered to detect differences in these metrics. Conclusions Our findings provide evidence of improved quality of life through improved self-care and clinical management from a mobile phone-based telemonitoring system. The use of the mobile phone-based system had high adherence and was feasible for patients, including the elderly and those with no experience with mobile phones. Trial Registration ClinicalTrials.gov NCT00778986

Effect of Home Blood Pressure Telemonitoring With Self-Care Support on Uncontrolled Systolic Hypertension in Diabetics

Lowering blood pressure reduces cardiovascular risk, yet hypertension is poorly controlled in diabetic patients. In a pilot study we demonstrated that a home blood pressure telemonitoring system, which provided self-care messages on the smartphone of hypertensive diabetic patients immediately after each reading, improved blood pressure control. Messages were based on care paths defined by running averages of transmitted readings. The present study tests the systems effectiveness in a randomized, controlled trial in diabetic patients with uncontrolled systolic hypertension. Of 244 subjects screened for eligibility, 110 (45%) were randomly allocated to the intervention (n=55) or control (n=55) group, and 105 (95.5%) completed the 1-year outcome visit. In the intention-to-treat analysis, mean daytime ambulatory systolic blood pressure, the primary end point, decreased significantly only in the intervention group by 9.1±15.6 mmHg (SD; P<0.0001), and the mean between-group difference was 7.1±2.3 mmHg (SE; P<0.005). Furthermore, 51% of intervention subjects achieved the guideline recommended target of <130/80 mmHg compared with 31% of control subjects (P<0.05). These improvements were obtained without the use of more or different antihypertensive medications or additional clinic visits to physicians. Providing self-care support did not affect anxiety but worsened depression on the Hospital Anxiety and Depression Scale (baseline, 4.1±3.76; exit, 5.2±4.30; P=0.014). This study demonstrated that home blood pressure telemonitoring combined with automated self-care support reduced the blood pressure of diabetic patients with uncontrolled systolic hypertension and improved hypertension control. Home blood pressure monitoring alone had no effect on blood pressure. Promoting patient self-care may have negative psychological effects.

mHealth consumer apps: the case for user-centered design.

mHealth applications, or “apps” as they are more commonly known, offer the opportunity to improve healthcare delivery and clinical outcomes. The ability to monitor patients remotely can enable patient risk-factor management and improve treatment compliance, thus allowing early detection of medical complications and ultimately preventing unnecessary hospitalizations. In addition to enhancing the delivery of care, one of the most significant opportunities that mHealth offers is in the consumer health domain, allowing patients to actively engage in and self manage their condition. Mobile phones also allow for the design of timely interventions based on user behavior. mHealth-mediated behavioral interventions can produce cognitive, behavioral, emotional, and social health-oriented responses. As such, mHealth apps are particularly appropriate for problems where treatments depend on patient behavioral change, such as those related to smoking, obesity, diabetes, and other chronic conditions. Despite the many potential benefits of mHealth apps, pilot studies aimed at evaluating the effectiveness of mHealth interventions have yielded mixed results. Furthermore, a quarter of all app downloads are used only once. Consumers often do not return to applications that do not immediately engage them, therefore undermining the intervention’s potential effectiveness. Regrettably, there is no simple formula for designing engaging and effective mHealth apps. Currently, many electronic health (eHealth) and mHealth interventions are designed on the basis of existing healthcare system constructs and may not be as effective as those that involve end users in the design process. Moreover, designers often base their designs on assumptions that are not validated with primary user input. The resulting systems may lack key features, and subsequent evaluations of the effectiveness of the interventions may be compromised. For this reason, we employ the user-centered design (UCD) process—an evidence-based approach informed by the needs and understanding of a specific end-user group. In our experience, designing mHealth and other apps, UCD plays a key role in achieving user engagement, thus improving the likelihood of the intervention’s effectiveness. The World Health Organization agrees, and advises that user evaluation be incorporated into the mHealth project lifecycle to ensure effective outcomes. mHealth Consumer Apps The Case for User-Centered Design

A game plan: Gamification design principles in mHealth applications for chronic disease management:

Effective chronic disease management is essential to improve positive health outcomes, and incentive strategies are useful in promoting self-care with longevity. Gamification, applied with mHealth (mobile health) applications, has the potential to better facilitate patient self-management. This review article addresses a knowledge gap around the effective use of gamification design principles, or mechanics, in developing mHealth applications. Badges, leaderboards, points and levels, challenges and quests, social engagement loops, and onboarding are mechanics that comprise gamification. These mechanics are defined and explained from a design and development perspective. Health and fitness applications with gamification mechanics include: bant which uses points, levels, and social engagement, mySugr which uses challenges and quests, RunKeeper which uses leaderboards as well as social engagement loops and onboarding, Fitocracy which uses badges, and Mango Health, which uses points and levels. Specific design considerations are explored, an example of the efficacy of a gamified mHealth implementation in facilitating improved self-management is provided, limitations to this work are discussed, a link between the principles of gaming and gamification in health and wellness technologies is provided, and suggestions for future work are made. We conclude that gamification could be leveraged in developing applications with the potential to better facilitate self-management in persons with chronic conditions.

Patient-Perceived Barriers to the Adoption of Nocturnal Home Hemodialysis

BACKGROUND AND OBJECTIVES Nocturnal home hemodialysis (NHHD) has been shown to improve clinical outcomes, although adoption has been limited. Given the known benefits, an understanding of the barriers to adoption is needed. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS Patient-perceived barriers were studied through a cross-sectional survey of prevalent hemodialysis patients using validated instruments, study-specific questions, and ethnographic interviews. Fifty-six of 66 NHHD patients and 153 of 199 conventional hemodialysis (CHD) patients were included in the survey. Twenty interviews were conducted with NHHD, CHD, and predialysis patients. RESULTS Compared with CHD patients, NHHD patients had higher perceived physical health scores (Short Form 12 [SF-12]: 41.47 +/- 10.9 versus 34.73 +/- 10.6, P < 0.0001), but had similar mental health scores (47.30 +/- 11.1[NHHD] versus 45.27 +/- 11.3[CHD]), P = 0.25). Despite having similar measures of education and perceived social support as NHHD patients, CHD patients had a low interest (1.68 [out of 5] +/- 1.26) in adopting NHHD. The major barriers perceived by CHD patients were lack of self-efficacy in performing the therapy, lack of confidence in self-cannulation, and length of time on current therapy. Similar themes emerged from the qualitative analysis as well as: burden on family members and fear of a catastrophic event. CONCLUSIONS Patient-perceived barriers are primarily fears of self-cannulation, a catastrophic event, and the burden on family. These findings should form the basis of screening patients for interest in NHHD and serve to mitigate these concerns.

Perceptions and experiences of heart failure patients and clinicians on the use of mobile phone-based telemonitoring.

Background Previous trials of heart failure telemonitoring systems have produced inconsistent findings, largely due to diverse interventions and study designs. Objectives The objectives of this study are (1) to provide in-depth insight into the effects of telemonitoring on self-care and clinical management, and (2) to determine the features that enable successful heart failure telemonitoring. Methods Semi-structured interviews were conducted with 22 heart failure patients attending a heart function clinic who had used a mobile phone-based telemonitoring system for 6 months. The telemonitoring system required the patients to take daily weight and blood pressure readings, weekly single-lead ECGs, and to answer daily symptom questions on a mobile phone. Instructions were sent to the patient’s mobile phone based on their physiological values. Alerts were also sent to a cardiologist’s mobile phone, as required. All clinicians involved in the study were also interviewed post-trial (N = 5). The interviews were recorded, transcribed, and then analyzed using a conventional content analysis approach. Results The telemonitoring system improved patient self-care by instructing the patients in real-time how to appropriately modify their lifestyle behaviors. Patients felt more aware of their heart failure condition, less anxiety, and more empowered. Many were willing to partially fund the use of the system. The clinicians were able to manage their patients’ heart failure conditions more effectively, because they had physiological data reported to them frequently to help in their decision-making (eg, for medication titration) and were alerted at the earliest sign of decompensation. Essential characteristics of the telemonitoring system that contributed to improved heart failure management included immediate self-care and clinical feedback (ie, teachable moments), how the system was easy and quick to use, and how the patients and clinicians perceived tangible benefits from telemonitoring. Some clinical concerns included ongoing costs of the telemonitoring system and increased clinical workload. A few patients did not want to be watched long-term while some were concerned they might become dependent on the system. Conclusions The success of a telemonitoring system is highly dependent on its features and design. The essential system characteristics identified in this study should be considered when developing telemonitoring solutions. Key Words

Self-care and quality of life of heart failure patients at a multidisciplinary heart function clinic.

Background:Multidisciplinary heart function clinics aim to improve self-care through patient education and to provide clinical management. Objective:The objectives of the present study were to investigate the self-care and quality of life of patients attending a multidisciplinary heart function clinic and to explore the relationship between self-care and quality of life. Methods:One hundred outpatients attending a multidisciplinary heart function clinic were asked to complete a questionnaire. The questionnaire included the Self-care of Heart Failure Index (SCHFI) and the Minnesota Living With Heart Failure Questionnaire, which were used to assess self-care behavior and quality of life, respectively. Self-care practices and perceived barriers were also assessed through semistructured interviews with each patient. Results:The returned questionnaires (n = 94) were used to compute the following SCHFI maintenance, management, and confidence scores: 60.8 (SD, 19.3), 62.0 (SD, 20.7), and 55.9 (SD, 19.7), respectively. Higher SCHFI scores indicate better self-care. None of the self-care dimensions reached the self-care adequacy cut point of 70. The average score on the Minnesota Living With Heart Failure Questionnaire was 49.9 (SD, 25.4), indicating a moderate health-related quality of life. Lower ejection fraction, older age, and better quality of life were associated with better self-care. Determinants of better quality of life were older age, better functional capacity, higher self-care confidence, and fewer comorbidities. The patient interviews revealed that better quality of life is associated with higher self-care confidence and barriers to self-care caused anxiety to the patients. The self-care barriers were found to include lack of self-care education, financial constraints, lack of perceived benefit, and low self-efficacy. Conclusions:Patients attending a large multidisciplinary Canadian heart failure clinic do not perform adequate self-care as measured with the SCHFI and report only a moderate quality of life. Increasing self-care through education and tools that target self-care barriers are required and may help improve quality of life.

Attitudes of heart failure patients and health care providers towards mobile phone-based remote monitoring.

Background Mobile phone-based remote patient monitoring systems have been proposed for heart failure management because they are relatively inexpensive and enable patients to be monitored anywhere. However, little is known about whether patients and their health care providers are willing and able to use this technology. Objective The objective of our study was to assess the attitudes of heart failure patients and their health care providers from a heart function clinic in a large urban teaching hospital toward the use of mobile phone-based remote monitoring. Methods A questionnaire regarding attitudes toward home monitoring and technology was administered to 100 heart failure patients (94/100 returned a completed questionnaire). Semi-structured interviews were also conducted with 20 heart failure patients and 16 clinicians to determine the perceived benefits and barriers to using mobile phone-based remote monitoring, as well as their willingness and ability to use the technology. Results The survey results indicated that the patients were very comfortable using mobile phones (mean rating 4.5, SD 0.6, on a five-point Likert scale), even more so than with using computers (mean 4.1, SD 1.1). The difference in comfort level between mobile phones and computers was statistically significant (P< .001). Patients were also confident in using mobile phones to view health information (mean 4.4, SD 0.9). Patients and clinicians were willing to use the system as long as several conditions were met, including providing a system that was easy to use with clear tangible benefits, maintaining good patient-provider communication, and not increasing clinical workload. Clinicians cited several barriers to implementation of such a system, including lack of remuneration for telephone interactions with patients and medicolegal implications. Conclusions Patients and clinicians want to use mobile phone-based remote monitoring and believe that they would be able to use the technology. However, they have several reservations, such as potential increased clinical workload, medicolegal issues, and difficulty of use for some patients due to lack of visual acuity or manual dexterity.

Developing healthcare rule-based expert systems: Case study of a heart failure telemonitoring system

BACKGROUND The use of expert systems to generate automated alerts and patient instructions based on telemonitoring data could enable increased self-care and improve clinical management. However, of great importance is the development of the rule set to ensure safe and clinically relevant alerts and instructions are sent. The purpose of this work was to develop a rule-based expert system for a heart failure mobile phone-based telemonitoring system, to evaluate the expert system, and to generalize the lessons learned from the development process for use in other healthcare applications. METHODS Semi-structured interviews were conducted with 10 heart failure clinicians to inform the development of a draft heart failure rule set for alerts and patient instructions. The draft rule set was validated and refined with 9 additional interviews with heart failure clinicians. Finally, the clinical champion of the project vetted the rule set. The concerns voiced by the clinicians during the interviews were noted, and methods to mitigate these concerns were employed. The rule set was then evaluated as part of a 6-month randomized controlled trial of a mobile phone-based heart failure telemonitoring system (n=50 for each of the telemonitoring and control groups). RESULTS The developed expert system generated alerts and instructions based on the patients weight, blood pressure, heart rate, and symptoms. During the trial, 1620 alerts were generated, which led to various clinical actions including 105 medication changes/instructions. The findings from the trial indicated the rule set was associated with improved quality of life and self-care. CONCLUSIONS A rule set was developed with extensive input by heart failure clinicians. The results from the trial indicated the rule set was associated with significantly increased self-care and improved the clinical management of heart failure. The developed rule set can be used as a basis for other heart failure telemonitoring systems, but should be validated and modified as necessary. In addition, the process used to develop the rule set can be generalized and applied to create robust and complete rule sets for other healthcare expert systems.