JMIR Publications

JMIR Human Factors

Making health care interventions and technologies usable, safe, and effective


Journal Description

JMIR Human Factors (JHF) is a new spin-off journal of JMIR, a leading open access eHealth journal (Impact Factor 2015: 4.532). 
JMIR Human Factors is a multidisciplinary journal with contributions from medical researchers, engineers, and social scientists.
JMIR Human Factors focuses on understanding how the behaviour and thinking of humans can influence and shape the design of health care interventions and technologies, and how the design can be evaluated and improved to make health care interventions and technologies usable, safe, and effective. JHF aspires to lead health care towards a culture of testing and safety by promoting and publishing reports rigorously evaluating the usability and human factors aspects in health care, as well as encouraging the development and debate on new methods in this emerging field. 
All articles are professionally copyedited and typeset, ready for indexing in PubMed/PubMed Central. Possible contributions include usability studies and heuristic evaluations, studies concerning ergonomics and error prevention, design studies for medical devices and healthcare systems/workflows, enhancing teamwork through Human Factors based teamwork training, measuring non-technical skills in staff like leadership, communication, situational awareness and teamwork, and healthcare policies and procedures to reduce errors and increase safety. Reviews, viewpoint papers and tutorials are as welcome as original research.

Editorial Board members are currently being recruited, please contact us if you are interested ( at


Recent Articles:

  • Man using computer and smart phone. Copyright: Image created by the authors using; URL: Image 1 source:, Image 2 source:; License: Licensed under Creative Commons Attribution 2.0..

    Design and Usability of a Heart Failure mHealth System: A Pilot Study


    Background: Despite the advances in mobile health (mHealth) systems, little is known about patients’ and providers’ experiences using a new mHealth system design. Objective: This study aimed to understand challenges and provide design considerations for a personalized mHealth system that could effectively support heart failure (HF) patients after they transition into the home environment. Methods: Following exploratory interviews with nurses and preventive care physicians, an mHealth system was developed. Patients were asked to measure their weight, blood pressure, and blood glucose (if they had diabetes). They were also instructed to enter symptoms, view notifications, and read messages on a mobile app that we developed. A Bluetooth-enabled weight scale, blood pressure monitor, glucometer, and mobile phone was provided after an introductory orientation and training session. HF nurses used a dashboard to view daily measurements for each patient and received text and email alerts when risk was indicated. Observations of usage, cases of deterioration, readmissions, and metrics related to system usability and quality of life outcomes were used to determine overall effectiveness of the system, whereas focus group sessions with patients were conducted to elicit participants’ feedback on the system’s design. Results: A total of 8 patients with HF participated over a 6-month period. Overall, the mean users’ satisfaction with the system ranked 73%, which was above average. Quality of life improvement was 3.6. Patients and nurses used the system on a regular basis and were able to successfully identify and manage 8 health deteriorations, of which 5 were completely managed remotely. Focus groups revealed that, on one hand, the system was beneficial and helped patients with: recording and tracking readings; receiving encouragement and reassurance from nurses; spotting and solving problems; learning from past experiences; and communication. On the other hand, findings also highlighted design issues and recommendations for future systems such as the need to communicate via other media, personalize symptom questions and messages, integrate other health tracking technologies, and provide additional methods to analyze and visualize their data. Conclusions: Understanding users’ experiences provides important design considerations that could complement existing design recommendations from the literature, and, when combined with physician and nurse requirements, have the potential to yield a feasible telehealth system that is effective in supporting HF self-care. Future studies will include these guidelines and use a larger sample size to validate the outcomes.

  • Image source: From Figure 11: Older adult users carrying out tasks using the user manual as a guide during the user testing.

    A Human-Centered Design Methodology to Enhance the Usability, Human Factors, and User Experience of Connected Health Systems: A Three-Phase Methodology


    Background: Design processes such as human-centered design, which involve the end user throughout the product development and testing process, can be crucial in ensuring that the product meets the needs and capabilities of the user, particularly in terms of safety and user experience. The structured and iterative nature of human-centered design can often present a challenge when design teams are faced with the necessary, rapid, product development life cycles associated with the competitive connected health industry. Objective: We wanted to derive a structured methodology that followed the principles of human-centered design that would allow designers and developers to ensure that the needs of the user are taken into account throughout the design process, while maintaining a rapid pace of development. In this paper, we present the methodology and its rationale before outlining how it was applied to assess and enhance the usability, human factors, and user experience of a connected health system known as the Wireless Insole for Independent and Safe Elderly Living (WIISEL) system, a system designed to continuously assess fall risk by measuring gait and balance parameters associated with fall risk. Methods: We derived a three-phase methodology. In Phase 1 we emphasized the construction of a use case document. This document can be used to detail the context of use of the system by utilizing storyboarding, paper prototypes, and mock-ups in conjunction with user interviews to gather insightful user feedback on different proposed concepts. In Phase 2 we emphasized the use of expert usability inspections such as heuristic evaluations and cognitive walkthroughs with small multidisciplinary groups to review the prototypes born out of the Phase 1 feedback. Finally, in Phase 3 we emphasized classical user testing with target end users, using various metrics to measure the user experience and improve the final prototypes. Results: We report a successful implementation of the methodology for the design and development of a system for detecting and predicting falls in older adults. We describe in detail what testing and evaluation activities we carried out to effectively test the system and overcome usability and human factors problems. Conclusions: We feel this methodology can be applied to a wide variety of connected health devices and systems. We consider this a methodology that can be scaled to different-sized projects accordingly.

  • App development. Image Source: Firmbee via Pixabay. Open source.

    Mobile Phone Apps for Smoking Cessation: Quality and Usability Among Smokers With Psychosis


    Background: Smoking is one of the top preventable causes of mortality in people with psychotic disorders such as schizophrenia. Cessation treatment improves abstinence outcomes, but access is a barrier. Mobile phone apps are one way to increase access to cessation treatment; however, whether they are usable by people with psychotic disorders, who often have special learning needs, is not known. Objective: Researchers reviewed 100 randomly selected apps for smoking cessation to rate them based on US guidelines for nicotine addiction treatment and to categorize them based on app functions. We aimed to test the usability and usefulness of the top-rated apps in 21 smokers with psychotic disorders. Methods: We identified 766 smoking cessation apps and randomly selected 100 for review. Two independent reviewers rated each app with the Adherence Index to US Clinical Practice Guideline for Treating Tobacco Use and Dependence. Then, smokers with psychotic disorders evaluated the top 9 apps within a usability testing protocol. We analyzed quantitative results using descriptive statistics and t tests. Qualitative data were open-coded and analyzed for themes. Results: Regarding adherence to practice guidelines, most of the randomly sampled smoking cessation apps scored poorly—66% rated lower than 10 out of 100 on the Adherence Index (Mean 11.47, SD 11.8). Regarding usability, three common usability problems emerged: text-dense content, abstract symbols on the homepage, and subtle directions to edit features. Conclusions: In order for apps to be effective and usable for this population, developers should utilize a balance of text and simple design that facilitate ease of navigation and content comprehension that will help people learn quit smoking skills.

  • Acute coronary syndrome patient booklet mortality statistics. Image sourced and copyright owned by authors.

    Negotiating Tensions Between Theory and Design in the Development of Mailings for People Recovering From Acute Coronary Syndrome


    Background: Taking all recommended secondary prevention cardiac medications and fully participating in a formal cardiac rehabilitation program significantly reduces mortality and morbidity in the year following a heart attack. However, many people who have had a heart attack stop taking some or all of their recommended medications prematurely and many do not complete a formal cardiac rehabilitation program. Objective: The objective of our study was to develop a user-centered, theory-based, scalable intervention of printed educational materials to encourage and support people who have had a heart attack to use recommended secondary prevention cardiac treatments. Methods: Prior to the design process, we conducted theory-based interviews and surveys with patients who had had a heart attack to identify key determinants of secondary prevention behaviors. Our interdisciplinary research team then partnered with a patient advisor and design firm to undertake an iterative, theory-informed, user-centered design process to operationalize techniques to address these determinants. User-centered design requires considering users’ needs, goals, strengths, limitations, context, and intuitive processes; designing prototypes adapted to users accordingly; observing how potential users respond to the prototype; and using those data to refine the design. To accomplish these tasks, we conducted user research to develop personas (archetypes of potential users), developed a preliminary prototype using behavior change theory to map behavior change techniques to identified determinants of medication adherence, and conducted 2 design cycles, testing materials via think-aloud and semistructured interviews with a total of 11 users (10 patients who had experienced a heart attack and 1 caregiver). We recruited participants at a single cardiac clinic using purposive sampling informed by our personas. We recorded sessions with users and extracted key themes from transcripts. We held interdisciplinary team discussions to interpret findings in the context of relevant theory-based evidence and iteratively adapted the intervention accordingly. Results: Through our iterative development and testing, we identified 3 key tensions: (1) evidence from theory-based studies versus users’ feelings, (2) informative versus persuasive communication, and (3) logistical constraints for the intervention versus users’ desires or preferences. We addressed these by (1) identifying root causes for users’ feelings and addressing those to better incorporate theory- and evidence-based features, (2) accepting that our intervention was ethically justified in being persuasive, and (3) making changes to the intervention where possible, such as attempting to match imagery in the materials to patients’ self-images. Conclusions: Theory-informed interventions must be operationalized in ways that fit with user needs. Tensions between users’ desires or preferences and health care system goals and constraints must be identified and addressed to the greatest extent possible. A cluster randomized controlled trial of the final intervention is currently underway.

  • App Prototype Home Screen. Image sourced and copyright owned by authors.

    A Self-Regulation Theory–Based Asthma Management Mobile App for Adolescents: A Usability Assessment


    Background: Self-regulation theory suggests people learn to influence their own behavior through self-monitoring, goal-setting, feedback, self-reward, and self-instruction, all of which smartphones are now capable of facilitating. Several mobile apps exist to manage asthma; however, little evidence exists about whether these apps employ user-centered design processes that adhere to government usability guidelines for mobile apps. Objective: Building upon a previous study that documented adolescent preferences for an asthma self-management app, we employed a user-centered approach to assess the usability of a high-fidelity wireframe for an asthma self-management app intended for use by adolescents with persistent asthma. Methods: Individual interviews were conducted with adolescents (ages 11-18 years) with persistent asthma who owned a smartphone (N=8). Adolescents were asked to evaluate a PDF app wireframe consisting of 76 screen shots displaying app features, including log in and home screen, profile setup, settings and info, self-management features, and graphical displays for charting asthma control and medication. Preferences, comments, and suggestions for each set of screen shots were assessed using the audio-recorded interviews. Two coders reached consensus on adolescent evaluations of the following aspects of app features: (1) usability, (2) behavioral intentions to use, (3) confusing aspects, and (4) suggestions for improvement. Results: The app wireframe was generally well received, and several suggestions for improvement were recorded. Suggestions included increased customization of charts and notifications, reminders, and alerts. Participants preferred longitudinal data about asthma control and medication use to be displayed using line graphs. All participants reported that they would find an asthma management app like the one depicted in the wireframe useful for managing their asthma. Conclusions: Early stage usability tests guided by government usability guidelines ( revealed areas for improvement for an asthma self-management app for adolescents. Addressing these areas will be critical to developing an engaging and effective asthma self-management app that is capable of improving adolescent asthma outcomes.

  • Time spent on the Internet and eHealth literacy. Image source: Author: Copyright: CC0 License Public Domain.

    eHealth Literacy: Predictors in a Population With Moderate-to-High Cardiovascular Risk


    Background: Electronic health (eHealth) literacy is a growing area of research parallel to the ongoing development of eHealth interventions. There is, however, little and conflicting information regarding the factors that influence eHealth literacy, notably in chronic disease. We are similarly ill-informed about the relationship between eHealth and health literacy, 2 related yet distinct health-related literacies. Objective: The aim of our study was to investigate the demographic, socioeconomic, technology use, and health literacy predictors of eHealth literacy in a population with moderate-to-high cardiovascular risk. Methods: Demographic and socioeconomic data were collected from 453 participants of the CONNECT (Consumer Navigation of Electronic Cardiovascular Tools) study, which included age, gender, education, income, cardiovascular-related polypharmacy, private health care, main electronic device use, and time spent on the Internet. Participants also completed an eHealth Literacy Scale (eHEALS) and a Health Literacy Questionnaire (HLQ). Univariate analyses were performed to compare patient demographic and socioeconomic characteristics between the low (eHEALS<26) and high (eHEALS≥26) eHealth literacy groups. To then determine the predictors of low eHealth literacy, multiple-adjusted generalized estimating equation logistic regression model was used. This technique was also used to examine the correlation between eHealth literacy and health literacy for 4 predefined literacy themes: navigating resources, skills to use resources, usefulness for oneself, and critical evaluation. Results: The univariate analysis showed that patients with lower eHealth literacy were older (68 years vs 66 years, P=.01), had lower level of education (P=.007), and spent less time on the Internet (P<.001). However, multiple-adjusted generalized estimating equation logistic regression model demonstrated that only the time spent on the Internet (P=.01) was associated with the level of eHealth literacy. Regarding the comparison between the eHEALS items and HLQ scales, a positive linear relationship was found for the themes “usefulness for oneself” (P=.049) and “critical evaluation” (P=.01). Conclusions: This study shows the importance of evaluating patients’ familiarity with the Internet as reflected, in part, by the time spent on the Internet. It also shows the importance of specifically assessing eHealth literacy in conjunction with a health literacy assessment in order to assess patients’ navigational knowledge and skills using the Internet, specific to the use of eHealth applications.

  • Woman taking child's temperature with thermometer. Image created and copyright owned by authors.

    Considerations for an Access-Centered Design of the Fever Thermometer in Low-Resource Settings: A Literature Review


    Background: The lack of adequate information about fever in low-resource settings, its unreliable self-assessment, and poor diagnostic practices may result in delayed care and under-or-overdiagnosis of diseases such as malaria. The mismatches of existing fever thermometers in the context of use imply that the diagnostic tools and connected services need to be studied further to address the challenges of fever-related illnesses and their diagnostics. Objective: This study aims to inform a product-service system approach to design a reliable and accessible fever thermometer and connected services, as well as contribute to the identification of innovative opportunities to improve health care in low-resource settings. Methods: To determine what factors impede febrile people seeking health care to access adequate fever diagnostics, a literature search was conducted in Google Scholar and PubMed with relevant keywords. Next, these factors were combined with a patient journey model to design a new product-service system for fever diagnostics in low-resource settings. Results: In total, 37 articles were reviewed. The five As framework was used to categorize the identified barriers. The results indicate that there is a poor distribution of reliable fever diagnostic practices among remote communities. This paper speaks to the global public health and design communities. Three complementary considerations are discussed that support the idea of a more holistic approach to the design of fever diagnostics: (1) understanding of the fever diagnostics patient journey, (2) identifying user groups of the thermometers in a specific health care system, and (3) assessing different needs and interests of the different users. Conclusions: Access to basic, primary health care may be enhanced with better information and technology design made through the involvement of system users.

  • Electronic Health Literacy. Image sourced and copyright owned by authors.

    Perceived and Performed eHealth Literacy: Survey and Simulated Performance Test


    Background: Electronic health (eHealth) literacy of consumers is essential in order to improve information and communication technology (ICT) use for health purposes by ordinary citizens. However, performed eHealth literacy is seldom studied. Therefore, the present study assessed perceived and performed eHealth literacy using the recent conceptualization of health literacy skills. Objective: The aim of this paper was to examine the association between perceived and performed eHealth literacies. Methods: In total, 82 Israeli adults participated in the study, all 50 years and older, with a mean age of 67 (SD 11). Of the participants, 60% (49/82) were women and 72% (59/82) had a post-secondary education. The participants were first surveyed and then tested in a computer simulation of health-related Internet tasks. Performed, perceived (eHealth Literacy Scale, eHEALS), and evaluated eHealth literacy were assessed, and performed eHealth literacy was also recorded and re-evaluated later. Performance was scored for successful completion of tasks, and was also assessed by two researchers for motivation, confidence, and amount of help provided. Results: The skills of accessing, understanding, appraising, applying, and generating new information had decreasing successful completion rates. Generating new information was least correlated with other skills. Perceived and performed eHealth literacies were moderately correlated (r=.34, P=.01) while facets of performance (ie, digital literacy and eHealth literacy) were highly correlated (r=.82, P<.001). Participants low and high in performed eHealth literacy were significantly different: low performers were older and had used the Internet for less time, required more assistance, and were less confident in their conduct than high performers. Conclusions: The moderate association between perceived and performed eHealth literacy indicates that the latter should be assessed separately. In as much, the assessment of performed eHealth literacy in clinical settings should entail the structuring of tasks as well as shortening and automatizing the assessment.

  • Longleat Maze. Image Source: Author: Niki Odolphie from Frome, England. Copyright: Creative Commons Attribution 2.0 Generic license.

    Designing eHealth Applications to Reduce Cognitive Effort for Persons With Severe Mental Illness: Page Complexity, Navigation Simplicity, and Comprehensibility


    Background: eHealth technologies offer great potential for improving the use and effectiveness of treatments for those with severe mental illness (SMI), including schizophrenia and schizoaffective disorder. This potential can be muted by poor design. There is limited research on designing eHealth technologies for those with SMI, others with cognitive impairments, and those who are not technology savvy. We previously tested a design model, the Flat Explicit Design Model (FEDM), to create eHealth interventions for individuals with SMI. Subsequently, we developed the design concept page complexity, defined via the design variables we created of distinct topic areas, distinct navigation areas, and number of columns used to organize contents and the variables of text reading level, text reading ease (a newly added variable to the FEDM), and the number of hyperlinks and number of words on a page. Objective: The objective of our study was to report the influence that the 19 variables of the FEDM have on the ability of individuals with SMI to use a website, ratings of a website’s ease of use, and performance on a novel usability task we created termed as content disclosure (a measure of the influence of a homepage’s design on the understanding user’s gain of a website). Finally, we assessed the performance of 3 groups or dimensions we developed that organize the 19 variables of the FEDM, termed as page complexity, navigational simplicity, and comprehensibility. Methods: We measured 4 website usability outcomes: ability to find information, time to find information, ease of use, and a user’s ability to accurately judge a website’s contents. A total of 38 persons with SMI (chart diagnosis of schizophrenia or schizoaffective disorder) and 5 mental health websites were used to evaluate the importance of the new design concepts, as well as the other variables in the FEDM. Results: We found that 11 of the FEDM’s 19 variables were significantly associated with all 4 usability outcomes. Most other variables were significantly related to 2 or 3 of these usability outcomes. With the 5 tested websites, 7 of the 19 variables of the FEDM overlapped with other variables, resulting in 12 distinct variable groups. The 3 design dimensions had acceptable coefficient alphas. Both navigational simplicity and comprehensibility were significantly related to correctly identifying whether information was available on a website. Page complexity and navigational simplicity were significantly associated with the ability and time to find information and ease-of-use ratings. Conclusions: The 19 variables and 3 dimensions (page complexity, navigational simplicity, and comprehensibility) of the FEDM offer evidence-based design guidance intended to reduce the cognitive effort required to effectively use eHealth applications, particularly for persons with SMI, and potentially others, including those with cognitive impairments and limited skills or experience with technology. The new variables we examined (topic areas, navigational areas, columns) offer additional and very simple ways to improve simplicity.

  • Structured Rounding Tools. Image sourced and copyright owned by authors.

    Impact of Structured Rounding Tools on Time Allocation During Multidisciplinary Rounds: An Observational Study


    Background: Recent research has shown evidence of disproportionate time allocation for patient communication during multidisciplinary rounds (MDRs). Studies have shown that patients discussed later during rounds receive lesser time. Objective: The aim of our study was to investigate whether disproportionate time allocation effects persist with the use of structured rounding tools. Methods: Using audio recordings of rounds (N=82 patients), we compared time allocation and communication breakdowns between a problem-based Subjective, Objective, Assessment, and Plan (SOAP) and a system-based Handoff Intervention Tool (HAND-IT) rounding tools. Results: We found no significant linear dependence of the order of patient presentation on the time spent or on communication breakdowns for both structured tools. However, for the problem-based tool, there was a significant linear relationship between the time spent on discussing a patient and the number of communication breakdowns (P<.05)––with an average of 1.04 additional breakdowns with every 120 seconds in discussion. Conclusions: The use of structured rounding tools potentially mitigates disproportionate time allocation and communication breakdowns during rounds, with the more structured HAND-IT, almost completely eliminating such effects. These results have potential implications for planning, prioritization, and training for time management during MDRs.

  • Hearing impairment. Image Source: Author: Clker-Free-Vector-Images. Copyright: CC0 Public Domain.

    Exploration of Deaf People’s Health Information Sources and Techniques for Information Delivery in Cape Town: A Qualitative Study for the Design and...


    Background: Many cultural and linguistic Deaf people in South Africa face disparity when accessing health information because of social and language barriers. The number of certified South African Sign Language interpreters (SASLIs) is also insufficient to meet the demand of the Deaf population in the country. Our research team, in collaboration with the Deaf communities in Cape Town, devised a mobile health app called SignSupport to bridge the communication gaps in health care contexts. We consequently plan to extend our work with a Health Knowledge Transfer System (HKTS) to provide Deaf people with accessible, understandable, and accurate health information. We conducted an explorative study to prepare the groundwork for the design and development of the system. Objectives: To investigate the current modes of health information distributed to Deaf people in Cape Town, identify the health information sources Deaf people prefer and their reasons, and define effective techniques for delivering understandable information to generate the groundwork for the mobile health app development with and for Deaf people. Methods: A qualitative methodology using semistructured interviews with sensitizing tools was used in a community-based codesign setting. A total of 23 Deaf people and 10 health professionals participated in this study. Inductive and deductive coding was used for the analysis. Results: Deaf people currently have access to 4 modes of health information distribution through: Deaf and other relevant organizations, hearing health professionals, personal interactions, and the mass media. Their preferred and accessible sources are those delivering information in signed language and with communication techniques that match Deaf people’s communication needs. Accessible and accurate health information can be delivered to Deaf people by 3 effective techniques: using signed language including its dialects, through health drama with its combined techniques, and accompanying the information with pictures in combination with simple text descriptions. Conclusions: We can apply the knowledge gained from this exploration to build the groundwork of the mobile health information system. We see an opportunity to design an HKTS to assist the information delivery during the patient-health professional interactions in primary health care settings. Deaf people want to understand the information relevant to their diagnosed disease and its self-management. The 3 identified effective techniques will be applied to deliver health information through the mobile health app.

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    Integrating Patient-Generated Health Data Into Clinical Care Settings or Clinical Decision-Making: Lessons Learned From Project HealthDesign


    Background: Patient-generated health data (PGHD) are health-related data created or recorded by patients to inform their self-care and understanding about their own health. PGHD is different from other patient-reported outcome data because the collection of data is patient-driven, not practice- or research-driven. Technical applications for assisting patients to collect PGHD supports self-management activities such as healthy eating and exercise and can be important for preventing and managing disease. Technological innovations (eg, activity trackers) are making it more common for people to collect PGHD, but little is known about how PGHD might be used in outpatient clinics. Objective: The objective of our study was to examine the experiences of health care professionals who use PGHD in outpatient clinics. Methods: We conducted an evaluation of Project HealthDesign Round 2 to synthesize findings from 5 studies funded to test tools designed to help patients collect PGHD and share these data with members of their health care team. We conducted semistructured interviews with 13 Project HealthDesign study team members and 12 health care professionals that participated in these studies. We used an immersion-crystallization approach to analyze data. Our findings provide important information related to health care professionals’ attitudes toward and experiences with using PGHD in a clinical setting. Results: Health care professionals identified 3 main benefits of PGHD accessibility in clinical settings: (1) deeper insight into a patient’s condition; (2) more accurate patient information, particularly when of clinical relevance; and (3) insight into a patient’s health between clinic visits, enabling revision of care plans for improved health goal achievement, while avoiding unnecessary clinic visits. Study participants also identified 3 areas of consideration when implementing collection and use of PGHD data in clinics: (1) developing practice workflows and protocols related to PGHD collection and use; (2) data storage, accessibility at the point of care, and privacy concerns; and (3) ease of using PGHD data. Conclusions: PGHD provides value to both patients and health care professionals. However, more research is needed to understand the benefit of using PGHD in clinical care and to identify the strategies and clinic workflow needs for optimizing these tools.

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  • Evaluation of a mobile phone app to support patient self-management of diabetes and hypertension in a FQHC

    Date Submitted: Mar 16, 2017

    Open Peer Review Period: Mar 17, 2017 - Mar 31, 2017

    Background: Thousands of mobile phone (mHealth) applications (apps) have been developed to support patient’s self-management of health conditions. Despite reporting improved outcomes, many studies...

    Background: Thousands of mobile phone (mHealth) applications (apps) have been developed to support patient’s self-management of health conditions. Despite reporting improved outcomes, many studies of mHealth apps are not adequately powered, have poor rates of retention, or have a high risk of bias in randomizing participants. mHealth technologies appear to hold promise for improving the self-management of chronic conditions across populations. Objective: The aim of this study was to evaluate the usability and clinical effectiveness of a commercial mHealth app used in the context of routine primary care practice in improving clinical outcomes for patients aged 18+ in a Federally Qualified Health Center (FQHC) with a uncontrolled diabetes and/or hypertension who had seen their provider within the past 6 months and/or were scheduled for an upcoming appointment. Methods: We used a quasi-experimental research design using a convenience sample recruited in person and by telephone in which the intervention group enrolled in the app and the comparison group did not. An a priori power analysis indicated we needed at least 64 patients per study group in order to have an effect size (Cohen’s d) of 0.5, desired statistical power level of .8. Clinical staff communicated with enrolled patients through the app as patients worked toward set goals. Results: Despite vigorous recruitment efforts, the trial was suspended due to low enrollment, and inconsistent participation by enrolled patients. To evaluate usability, we interviewed staff and enrolled patients using a published framework that addresses usability in user, task, and interface dimensions for the development of e-Health. Both groups noted that the app was “one more thing” to attend to, and that the app was not integrated with patients’ electronic health record. Conclusions: This brief trial underscores pitfalls in the utilization of mHealth apps for patients in FQHCs. Effective use of mHealth tools requires a good fit between the app, the treatment approach, and user characteristics, such as technological aptitude and motivation for change. Unlike similar trials, our treatment approach was routine primary care, and did not include clinical staff with dedicated time to work specifically with the patients using the app, an unreimbursed activity, but one that might meet with better results. Clinical Trial: None