Prioritization of Quality Principles for Health Apps Using the Kano Model: Survey Study

Background Health apps are often used without adequately taking aspects related to their quality under consideration. This may partially be due to inadequate awareness about necessary criteria and how to prioritize them when evaluating an app. Objective The aim of this study was to introduce a method for prioritizing quality attributes in the mobile health context. To this end, physicians were asked about their assessment of nine app quality principles relevant in health contexts and their responses were used as a basis for designing a method for app prioritization. Ultimately, the goal was to aid in making better use of limited resources (eg, time) by assisting with the decision as to the specific quality principles that deserve priority in everyday medical practice and those that can be given lower priority, even in cases where the overall principles are rated similarly. Methods A total of 9503 members of two German professional societies in the field of orthopedics were invited by email to participate in an anonymous online survey over a 1-month period. Participants were asked to rate a set of nine app quality principles using a Kano survey with functional and dysfunctional (ie, positively and negatively worded) questions. The evaluation was based on the work of Kano (baseline), supplemented by a self-designed approach. Results Among the 9503 invited members, 382 completed relevant parts of the survey (return rate of 4.02%). These participants were equally and randomly assigned to two groups (test group and validation group, n=191 each). Demographic characteristics did not significantly differ between groups (all P>.05). Participants were predominantly male (328/382, 85.9%) and older than 40 years (290/382, 75.9%). Given similar ratings, common evaluation strategies for Kano surveys did not allow for conclusive prioritization of the principles, and the same was true when using the more elaborate approach of satisfaction and dissatisfaction indices following the work of Timko. Therefore, an extended, so-called “in-line-of-sight” method was developed and applied for this evaluation. Modified from the Timko method, this approach is based on a “point of view” (POV) metric, which generates a ranking coefficient. Although the principles were previously almost exclusively rated as must-be (with the exception of resource efficiency), which was not conducive to their prioritization, the new method applied from the must-be POV resulted in identical rankings for the test and validation groups: (1) legal conformity, (2) content validity, (3) risk adequacy, (4) practicality, (5) ethical soundness, (6) usability, (7) transparency, (8) technical adequacy, and (9) resource efficiency. Conclusions Established survey methodologies based on the work of Kano predominantly seek to categorize the attributes to be evaluated. The methodology presented here is an interesting option for prioritization, and enables focusing on the most important criteria, thus saving valuable time when reviewing apps for use in the medical field, even with otherwise largely similar categorization results. The extent to which this approach is applicable beyond the scenario presented herein requires further investigation.

App-Based Relaxation Exercises for Patients With Chronic Neck Pain: Pragmatic Randomized Trial

Background Chronic neck pain is a highly prevalent condition. Learning a relaxation technique is recommended by numerous guidelines for chronic neck pain. Smartphone apps can provide relaxation exercises; however, their effectiveness, especially in a self-care setting, is unclear. Objective The aim of this pragmatic randomized trial is to evaluate whether app-based relaxation exercises, including audio-based autogenic training, mindfulness meditation, or guided imagery, are more effective in reducing chronic neck pain than usual care alone. Methods Smartphone owners aged 18 to 65 years with chronic (>12 weeks) neck pain and the previous week’s average neck pain intensity ≥4 on the Numeric Rating Scale (0=no pain to 10=worst possible pain) were randomized into either an intervention group to practice app-based relaxation exercises or a control group (usual care and app for data entry only). For both groups, the follow-up data were collected using app-based diaries and questionnaires. The primary outcome was the mean neck pain intensity during the first 3 months based on daily measurements. Secondary outcomes included neck pain based on weekly measurements, pain acceptance, neck pain–related stress, sick-leave days, pain medication intake, and adherence, which were all measured until the 6-month follow-up. For the primary analysis, analysis of covariance adjusted for baseline neck pain intensity was used. Results We screened 748 participants and enrolled 220 participants (mean age 38.9, SD 11.3 years; mean baseline neck pain 5.7, SD 1.3 points). The mean neck pain intensity in both groups decreased over 3 months; however, no statistically significant difference between the groups was found (intervention: 4.1 points, 95% CI 3.8-4.4; control: 3.8 points, 95% CI 3.5-4.1; group difference: 0.3 points, 95% CI −0.2 to 0.7; P=.23). In addition, no statistically significant between-group differences regarding neck pain intensity after 6 months, responder rate, pain acceptance, pain medication intake, or sick-leave days were observed. There were no serious adverse events that were considered related to the trial intervention. In week 12, only 40% (44/110) of the participants in the intervention group continued to practice the exercises with the app. Conclusions The study app did not effectively reduce chronic neck pain or keep the participants engaged in exercising in a self-care setting. Future studies on app-based relaxation interventions should take into account the most recent scientific findings for behavior change techniques. Trial Registration ClinicalTrials.gov NCT02019134; https://clinicaltrials.gov/ct2/show/NCT02019134 International Registered Report Identifier (IRRID) RR2-10.1186/1745-6215-15-490

Enabling Research and Clinical Use of Patient-Generated Health Data (the mindLAMP Platform): Digital Phenotyping Study

Background There is a growing need for the integration of patient-generated health data (PGHD) into research and clinical care to enable personalized, preventive, and interactive care, but technical and organizational challenges, such as the lack of standards and easy-to-use tools, preclude the effective use of PGHD generated from consumer devices, such as smartphones and wearables. Objective This study outlines how we used mobile apps and semantic web standards such as HTTP 2.0, Representational State Transfer, JSON (JavaScript Object Notation), JSON Schema, Transport Layer Security (version 1.3), Advanced Encryption Standard-256, OpenAPI, HTML5, and Vega, in conjunction with patient and provider feedback to completely update a previous version of mindLAMP. Methods The Learn, Assess, Manage, and Prevent (LAMP) platform addresses the abovementioned challenges in enhancing clinical insight by supporting research, data analysis, and implementation efforts around PGHD as an open-source solution with freely accessible and shared code. Results With a simplified programming interface and novel data representation that captures additional metadata, the LAMP platform enables interoperability with existing Fast Healthcare Interoperability Resources–based health care systems as well as consumer wearables and services such as Apple HealthKit and Google Fit. The companion Cortex data analysis and machine learning toolkit offer robust support for artificial intelligence, behavioral feature extraction, interactive visualizations, and high-performance data processing through parallelization and vectorization techniques. Conclusions The LAMP platform incorporates feedback from patients and clinicians alongside a standards-based approach to address these needs and functions across a wide range of use cases through its customizable and flexible components. These range from simple survey-based research to international consortiums capturing multimodal data to simple delivery of mindfulness exercises through personalized, just-in-time adaptive interventions.

A Mobile App to Increase Fruit and Vegetable Acceptance Among Finnish and Polish Preschoolers: Randomized Trial

Background Early childhood education and care (ECEC) centers are ideal venues for food education. As smartphones and tablets are becoming increasingly popular in ECEC centers, technology can be used to deliver such pedagogical content. Evidence suggests that video games can affect fruit and vegetable (FV) consumption among 9- to 12-year-old children, but studies among preschoolers are scarce. Objective This paper describes the development of the Mole’s Veggie Adventures app and its effectiveness in increasing FV acceptance among Finnish and Polish preschoolers aged 3 to 6 years. Methods A multiprofessional team created an app to be used in ECEC centers in groups of 3 to 10 children. The app aimed to increase vegetable acceptance, and it was built using elements that support the development of self-regulation and social skills. Altogether, 7 Finnish and 4 Polish ECEC centers participated in the study. Before randomization, parents reported background factors and their children’s willingness to taste different FVs. The ECEC professionals in the intervention arm were instructed to use the app at least once a week during the 3- to 4-week intervention period. The main outcomes in this unblinded, cluster-randomized study were FV acceptance and relative FV acceptance. The first was calculated as a sum variable describing the children’s willingness to taste 25 different FVs, the second as FV acceptance divided by the number of FVs served. We used analysis of covariance to compare the FV acceptance and relative FV acceptance scores between the intervention and control groups at follow-up. Results A total of 221 children were included in the analysis. At follow-up, the intervention group (115/221, 52%) had higher FV acceptance scores (baseline adjusted difference of mean 7.22; 95% CI 1.41-13.03) than the control group (106/221, 48%). The intervention effect was parallel for relative FV acceptance scores (baseline adjusted difference of mean 0.28; 95% CI 0.05-0.52). Conclusions The Mole’s Veggie Adventures app has the potential to increase FV acceptance among preschoolers and can be a valuable tool in supporting food education in ECEC centers. Furthermore, the app can be feasibly incorporated into preschool routines in countries with different educational environments. Trial Registration ClinicalTrials.gov NCT05173311; https://tinyurl.com/4vfbh283

Dose–Response Effects of Patient Engagement on Health Outcomes in an mHealth Intervention: Secondary Analysis of a Randomized Controlled Trial

Background The dose–response relationship between patient engagement and long-term intervention effects in mobile health (mHealth) interventions are understudied. Studies exploring long-term and potentially changing relationships between patient engagement and health outcomes in mHealth interventions are needed. Objective This study aims to examine dose–response relationships between patient engagement and 3 psychosocial outcomes in an mHealth intervention, Run4Love, using repeated measurements of outcomes at baseline and 3, 6, and 9 months. Methods This study is a secondary analysis using longitudinal data from the Run4Love trial, a randomized controlled trial with 300 people living with HIV and elevated depressive symptoms to examine the effects of a 3-month mHealth intervention on reducing depressive symptoms and improving quality of life (QOL). We examined the relationships between patient engagement and depressive symptoms, QOL, and perceived stress in the intervention group (N=150) using 4–time-point outcome measurements. Patient engagement was assessed using the completion rate of course assignments and frequency of items completed. Cluster analysis was used to categorize patients into high- and low-engagement groups. Generalized linear mixed effects models were conducted to investigate the dose–response relationships between patient engagement and outcomes. Results The cluster analysis identified 2 clusters that were distinctively different from each other. The first cluster comprised 72 participants with good compliance to the intervention, completing an average of 74% (53/72) of intervention items (IQR 0.22). The second cluster comprised 78 participants with low compliance to the intervention, completing an average of 15% (11/72) of intervention items (IQR 0.23). Results of the generalized linear mixed effects models showed that, compared with the low-engagement group, the high-engagement group had a significant reduction in more depressive symptoms (β=−1.93; P=.008) and perceived stress (β=−1.72; P<.001) and an improved QOL (β=2.41; P=.01) over 9 months. From baseline to 3, 6, and 9 months, the differences in depressive symptoms between the 2 engagement groups were 0.8, 1.6, 2.3, and 3.7 points, respectively, indicating widening between-group differences over time. Similarly, between-group differences in QOL and perceived stress increased over time (group differences in QOL: 0.9, 1.9, 4.7, and 5.1 points, respectively; group differences in the Perceived Stress Scale: 0.9, 1.4, 2.3, and 3.0 points, respectively). Conclusions This study revealed a positive long-term dose–response relationship between patient engagement and 3 psychosocial outcomes among people living with HIV and elevated depressive symptoms in an mHealth intervention over 9 months using 4 time-point repeat measurement data. The high- and low-engagement groups showed significant and widening differences in depressive symptoms, QOL, and perceived stress at the 3-, 6-, and 9-month follow-ups. Future mHealth interventions should improve patient engagement to achieve long-term and sustained intervention effects. Trial Registration Chinese Clinical Trial Registry ChiCTR-IPR-17012606; https://www.chictr.org.cn/showproj.aspx?proj=21019

Personalized Reminders for Immunization Using Short Messaging Systems to Improve Human Papillomavirus Vaccination Series Completion: Parallel-Group Randomized Trial

Background Completion rates among adolescents who initiate the human papillomavirus (HPV) vaccine 3-dose series are low. SMS text message vaccine reminders are effective, but less is known about the best types for HPV series completion or the ability to assess and target vaccine decision-making stage. Objective The aim of this study is to compare the effectiveness of HPV vaccine series completion in minority adolescents who received precision and educational versus conventional SMS text message reminders. Methods Enrolled parents of adolescents aged 9-17 years who received the first HPV vaccine dose at 1 of the 4 academic-affiliated community health clinics in New York City were randomized 1:1 to 1 of the 2 parallel, unblinded arms: precision SMS text messages (which included stage-targeted educational information, next dose due date, and site-specific walk-in hours) or conventional SMS text messages without educational information. Randomization was stratified according to gender, age, and language. The primary outcome was series completion within 12 months. In post hoc analysis, enrollees were compared with concurrent nonenrollees and historical controls. Results Overall, 956 parents were enrolled in the study. The precision (475 families) and conventional (481 families) SMS text message arms had similarly high series completion rates (344/475, 72.4% vs 364/481, 75.7%). A total of 42 days after the first dose, two-thirds of families, not initially in the preparation stage, moved to preparation or vaccinated stage. Those in either SMS text message arm had significantly higher completion rates than nonenrollees (708/1503, 47.1% vs 679/1503, 45.17%; P<.001). Even after removing those needing only 2 HPV doses, adolescents receiving any SMS text messages had higher completion rates than historical controls (337/2823, 11.93% vs 981/2823, 34.75%; P<.001). A population-wide effect was seen from 2014 to 2016, above historical trends. Conclusions SMS text message reminders led to timely HPV vaccine series completion in a low-income, urban, minority study population and also led to population-wide effects. Educational information did not provide an added benefit to this population. Trial Registration ClinicalTrials.gov NCT02236273; https://clinicaltrials.gov/ct2/show/NCT02236273

A Wearable Activity Tracker Intervention With and Without Weekly Behavioral Support Emails to Promote Physical Activity Among Women Who Are Overweight or Obese: Randomized Controlled Trial

Background Physical activity (PA) plays a fundamental role in combating the current obesity epidemic; however, most women who are overweight or obese are generally physically inactive. Wearable activity tracker interventions can help increase the PA levels in this population. Supplementing such interventions with behavioral support emails may further improve their effectiveness, but this remains to be confirmed. Objective This study aims to determine if adding behavioral support emails to a wearable activity tracker intervention can further increase PA levels among women who are overweight or obese in comparison to a wearable activity tracker–only intervention and a control condition. Methods Women with a BMI ≥25 kg/m2 who were not meeting the Canadian PA guidelines for aerobic and strength training were randomized into 1 of 3 groups. Group 1 received 6 weekly behavioral support emails, a wearable activity tracker, and a copy of the Canadian PA guidelines. Group 2 received a wearable activity tracker and a copy of the Canadian PA guidelines, and group 3 (control condition) received a copy of the Canadian PA guidelines. Self-reported data for walking and moderate to vigorous intensity PA were collected preintervention (week 0; prerandomization), postintervention (7 weeks postrandomization), and at follow-up (21 weeks postrandomization) and analyzed as metabolic equivalent of task minutes per week. In addition, potential mechanisms of behavior change (ie, basic psychological needs satisfaction and motivational regulations) were assessed for within- and between-group differences at all 3 time points. Data were analyzed using nonparametric statistical tests. Results A total of 49 women were recruited; data from 47 women (mean age 37.57 years, SD 11.78 years; mean BMI 31.69 kg/m2, SD 5.97 kg/m2) were available for analysis. Group 1 reported a significant increase in walking from preintervention to postintervention (χ22=7.5; P=.02) but not in moderate to vigorous intensity PA (P=.24). Group 1 also reported significant increases in perceptions of competence from preintervention to follow-up (χ22=7.6; P=.02) and relatedness from preintervention to follow-up (χ22=8.7; P=.005). Increases in perceived autonomy were observed for group 2 (χ22=7.0) and group 3 (χ22=10.6). There were no significant changes in the motivational regulations within the groups. The difference between the groups was not significant for any outcome variable. Conclusions The results suggest that adding behavioral support emails to a wearable activity tracker intervention may help to increase time spent walking and perceptions of competence and relatedness for PA among women who are overweight or obese. Trial Registration ClinicalTrials.gov NCT03601663; http://clinicaltrials.gov/ct2/show/NCT03601663

An Intelligent Individualized Cardiovascular App for Risk Elimination (iCARE) for Individuals With Coronary Heart Disease: Development and Usability Testing Analysis

Background Death and disability from coronary heart disease (CHD) can be largely reduced by improving risk factor management. However, adhering to evidence-based recommendations is challenging and requires interventions at the level of the patient, provider, and health system. Objective The aim of this study was to develop an Intelligent Individualized Cardiovascular App for Risk Elimination (iCARE) to facilitate adherence to health behaviors and preventive medications, and to test the usability of iCARE. Methods We developed iCARE based on a user-centered design approach, which included 4 phases: (1) function design, (2) iterative design, (3) expert inspections and walkthroughs of the prototypes, and (4) usability testing with end users. The usability testing of iCARE included 2 stages: stage I, which included a task analysis and a usability evaluation (January to March 2019) of the iCARE patient app using the modified Health Information Technology Usability Survey (Health-ITUES); and stage II (June 2020), which used the Health-ITUES among end users who used the app for 6 months. The end users were individuals with a confirmed diagnosis of CHD from 2 university-affiliated hospitals in Beijing, China. Results iCARE consists of a patient app, a care provider app, and a cloud platform. It has a set of algorithms that trigger tailored feedback and can send individualized interventions based on data from initial assessment and health monitoring via manual entry or wearable devices. For stage I usability testing, 88 hospitalized patients (72% [63/88] male; mean age 60 [SD 9.9] years) with CHD were included in the study. The mean score of the usability testing was 90.1 (interquartile range 83.3-99.0). Among enrolled participants, 90% (79/88) were satisfied with iCARE; 94% (83/88) and 82% (72/88) reported that iCARE was useful and easy to use, respectively. For stage II usability testing, 61 individuals with CHD (85% [52/61] male; mean age 53 [SD 8.2] years) who were from an intervention arm and used iCARE for at least six months were included. The mean total score on usability testing based on the questionnaire was 89.0 (interquartile distance: 77.0-99.5). Among enrolled participants, 89% (54/61) were satisfied with the use of iCARE, 93% (57/61) perceived it as useful, and 70% (43/61) as easy to use. Conclusions This study developed an intelligent, individualized, evidence-based, and theory-driven app (iCARE) to improve patients’ adherence to health behaviors and medication management. iCARE was identified to be highly acceptable, useful, and easy to use among individuals with a diagnosis of CHD. Trial Registration Chinese Clinical Trial Registry ChiCTR-INR-16010242; https://tinyurl.com/2p8bkrew

Long-Term Effectiveness of a Decision Support App (Pink Journey) for Women Considering Breast Reconstruction Surgery: Pilot Randomized Controlled Trial

Background Various kinds of breast reconstruction (BR) options, including implants and autologous, and surgery techniques, including traditional and endoscope assisted, can be used to perform surgery. All options have their own advantages and disadvantages. Women decide on an option depending on the values and preferences they emphasize. Lacking knowledge about BR or having decision difficulties during the treatment decision process makes women experience more decision regret, psychological distress, and poor body image. Delivering decision support with a values clarification exercise using eHealth approaches would be beneficial for patient outcomes. Objective This study aims to examine the effects of a decision support app on decision-making quality and psychological morbidity for women considering BR surgery. Methods This randomized controlled trial included women who were over 20 years of age and were newly diagnosed with breast cancer and candidates for mastectomy. Women having an option for breast conservation were excluded. After being referred from the outpatient physician, the women provided consent and completed the baseline assessment. Women allocated to the control group (CG) received usual care and were provided with a pamphlet with information about types of surgery and the advantages and disadvantages of different surgery types. Women allocated to the intervention group (IG) were given the same pamphlet and guided to use the Pink Journey app to support their decision. Then they were also prompted to discuss the opinions with their significant others. Finally, the decision-making process of using the app was printed out for women that they could take home. Decision conflict, anxiety, and depression were measured at baseline. At 1 week after the intervention (T1) and at 1 month (T2), 8 months (T3), and 12 months (T4) after surgery, the women completed decision conflict, decision regret, anxiety, depression, and body image scales. An intention-to-treat analysis was performed. Results From February 2018 to July 2019, 96 women were randomly assigned to the CG (n=48) or the IG (n=48). Results revealed that body image distress declined significantly for the IG but increased for the CG. The interaction of time and group also reached significance, indicating a significant decrease in body image distress from baseline in the IG compared with the CG after the 12th month (T4) follow-up (β=–2.25, standard error=1.01, P=.027). However, there was no significant difference in decision conflict (P=.21-.87), decision regret (P=.44-.55), anxiety (P=.26-.33), and depression (P=.20-.75), indicating that the decrease in these outcomes in the IG was not greater than those in the CG. Conclusions Although we found no effect on decision conflict, decision regret, anxiety, and depression, a decision aid that combines surgery information and values clarification can help women reduce their body image distress. Trial Registration ClinicalTrials.gov NCT04190992; https://clinicaltrials.gov/ct2/show/NCT04190992

Evaluation of a Language Translation App in an Undergraduate Medical Communication Course: Proof-of-Concept and Usability Study

Background Language barriers in medical encounters pose risks for interactions with patients, their care, and their outcomes. Because human translators, the gold standard for mitigating language barriers, can be cost- and time-intensive, mechanical alternatives such as language translation apps (LTA) have gained in popularity. However, adequate training for physicians in using LTAs remains elusive. Objective A proof-of-concept pilot study was designed to evaluate the use of a speech-to-speech LTA in a specific simulated physician-patient situation, particularly its perceived usability, helpfulness, and meaningfulness, and to assess the teaching unit overall. Methods Students engaged in a 90-min simulation with a standardized patient (SP) and the LTA iTranslate Converse. Thereafter, they rated the LTA with six items—helpful, intuitive, informative, accurate, recommendable, and applicable—on a 7-point Likert scale ranging from 1 (don’t agree at all) to 7 (completely agree) and could provide free-text responses for four items: general impression of the LTA, the LTA’s benefits, the LTA’s risks, and suggestions for improvement. Students also assessed the teaching unit on a 6-point scale from 1 (excellent) to 6 (insufficient). Data were evaluated quantitatively with mean (SD) values and qualitatively in thematic content analysis. Results Of 111 students in the course, 76 (68.5%) participated (59.2% women, age 20.7 years, SD 3.3 years). Values for the LTA’s being helpful (mean 3.45, SD 1.79), recommendable (mean 3.33, SD 1.65) and applicable (mean 3.57, SD 1.85) were centered around the average of 3.5. The items intuitive (mean 4.57, SD 1.74) and informative (mean 4.53, SD 1.95) were above average. The only below-average item concerned its accuracy (mean 2.38, SD 1.36). Students rated the teaching unit as being excellent (mean 1.2, SD 0.54) but wanted practical training with an SP plus a simulated human translator first. Free-text responses revealed several concerns about translation errors that could jeopardize diagnostic decisions. Students feared that patient-physician communication mediated by the LTA could decrease empathy and raised concerns regarding data protection and technical reliability. Nevertheless, they appreciated the LTA’s cost-effectiveness and usefulness as the best option when the gold standard is unavailable. They also reported wanting more medical-specific vocabulary and images to convey all information necessary for medical communication. Conclusions This study revealed the feasibility of using a speech-to-speech LTA in an undergraduate medical course. Although human translators remain the gold standard, LTAs could be valuable alternatives. Students appreciated the simulated teaching and recognized the LTA’s potential benefits and risks for use in real-world clinical settings. To optimize patients’ and health care professionals’ experiences with LTAs, future investigations should examine specific design options for training interventions and consider the legal aspects of human-machine interaction in health care settings.