Digital Therapeutic Research Articles

Designing Digital Therapeutic Content Using Chronic Disease Data: A Focus on Improving Urinary Dysfunction.

In recent years, advancements in information and communication technologies, including artificial intelligence, big data, virtual reality, and augmented reality, have driven substantial growth in the field of digital medical diagnosis and treatment, thereby enhancing quality of life. Beginning in the mid-2010s with the advent of digital healthcare applications, and further accelerated by the impact of coronavirus disease 2019, digital therapeutic products have profoundly influenced society. Nevertheless, the expansion of digital therapeutics has encountered challenges associated with regulatory hurdles, differentiation from general digital healthcare, and the necessity for trustworthiness, which have contributed to a slower rate of progress. This study proposes a 3P content model-encompassing pre-education, prediction/diagnosis/treatment, and postmanagement-to increase the trustworthiness of digital therapeutics. The design of the 3P content model includes a fundamental structure that establishes networks with healthcare institutions, aiming to increase the reliability of data utilization and to facilitate integration with medical decision support systems. For case development, the study introduces a prototype of a mobile application that utilizes chronic disease urinary dysfunction data, demonstrating the cyclical structure inherent in the 3P content model.

Examining the Feasibility of Implementing Digital Mental Health Innovations Into Hospitals to Support Youth in Suicide Crisis: Interview Study With Young People and Health Professionals.

Hospitals are insufficiently resourced to appropriately support young people who present with suicidal crises. Digital mental health innovations have the potential to provide cost-effective models of care to address this service gap and improve care experiences for young people. However, little is currently known about whether digital innovations are feasible to integrate into complex hospital settings or how they should be introduced for sustainability. This qualitative study explored the potential benefits, barriers, and collective action required for integrating digital therapeutics for the management of suicidal distress in youth into routine hospital practice. Addressing these knowledge gaps is a critical first step in designing digital innovations and implementation strategies that enable uptake and integration. We conducted a series of semistructured interviews with young people who had presented to an Australian hospital for a suicide crisis in the previous 12 months and hospital staff who interacted with these young people. Participants were recruited from the community nationally via social media advertisements on the web. Interviews were conducted individually, and participants were reimbursed for their time. Using the Normalization Process Theory framework, we developed an interview guide to clarify the processes and conditions that influence whether and how an innovation becomes part of routine practice in complex health systems. Analysis of 29 interviews (n=17, 59% young people and n=12, 41% hospital staff) yielded 4 themes that were mapped onto 3 Normalization Process Theory constructs related to coherence building, cognitive participation, and collective action. Overall, digital innovations were seen as a beneficial complement to but not a substitute for in-person clinical services. The timing of delivery was important, with the agreement that digital therapeutics could be provided to patients while they were waiting to be assessed or shortly before discharge. Staff training to increase digital literacy was considered key to implementation, but there were mixed views on the level of staff assistance needed to support young people in engaging with digital innovations. Improving access to technological devices and internet connectivity, increasing staff motivation to facilitate the use of the digital therapeutic, and allowing patients autonomy over the use of the digital therapeutic were identified as other factors critical to integration. Integrating digital innovations into current models of patient care for young people presenting to hospital in acute suicide crises is challenging because of several existing resource, logistical, and technical barriers. Scoping the appropriateness of new innovations with relevant key stakeholders as early as possible in the development process should be prioritized as the best opportunity to preemptively identify and address barriers to implementation.

Digital Therapeutic Exercises Using Augmented Reality Glasses for Frailty Prevention among Older Adults.

The objective of this study was to investigate the effects of a digital therapeutic exercise platform for pre-frail or frail elderly individuals using augmented reality (AR) technology accessed through glasses. A tablet-based exercise program was utilized for the control group, and a non-inferiority assessment was employed. The participants included older adult women aged 65 years and older residing in Incheon, South Korea. A digital therapeutic exercise program involving AR glasses or tablet-based exercise was administered twice a week for 12 weeks, with gradually increasing exercise duration. Statistical analysis was conducted using the t-test and Wilcoxon rank sum test for non-inferiority assessment. In the primary efficacy assessment, regarding the change in lower limb strength, a non-inferior result was observed for the intervention group (mean change, 5.46) relative to the control group (mean change, 4.83), with a mean difference of 0.63 between groups (95% confidence interval, -2.33 to 3.58). Changes in body composition and physical fitness-related variables differed non-significantly between the groups. However, the intervention group demonstrated a significantly greater increase in cardiorespiratory endurance (p < 0.005) and a significantly larger decrease in the frailty index (p < 0.001). An AR-based digital therapeutic program significantly and positively contributed to the improvement of cardiovascular endurance and the reduction of indicators of aging among older adults. These findings underscore the value of digital therapeutics in mitigating the effects of aging.

The increasing use of digital therapeutics of insomnia and other sleep disorders: a systematic review

Abstract Background Chronic insomnia is a significant public health problem affecting 15% of the adult population worldwide. There have been few research trials on digital therapeutics (Dtx) for insomnia and other sleep initiation and maintenance disorders (ISMD), and even less real world evaluations of their efficacy. The aim of this review is to describe the digital therapeutic (Dtx) solutions that have been reported in the scientific literature to mitigate the impact of ISMD on individuals. Methods We conducted a systematic review of Dtx and insomnia-related literature (with no time limits) by searching MEDLINE/Pubmed and Scopus with appropriate terms to find relevant articles. We included only primary studies and exluded those on patients with diseases other than ISMD. We extracted study characteristics such as the paper title, journal, and publication year, and we categorized them by setting of the study, type of technology/device, type of treatment provided, primary outcome, and clinical results of the Dtx use for ISMD. Results The search identified 129 articles, of which 15 full-text articles were assessed and included in the review after duplicate removal and screening. Most of the selected articles were randomized controlled trials (RTCs 60%) and real-world studies (40%) published between 2016 and 2023, and using the following types of digital technologies: mobile apps (66%), web-based programs (7%), and mixed solutions (27%). We report that these digital solutions provide digital-Cognitive Behavioural Therapy (d-CBT 67%), mindfullness (13%) and other treatments (20%). Many scientific contributions use the Insomnia Severity Index (47%) and sleep latency (20%) as primary outcomes, and all the included studies report significant improvements in ISMD control. Conclusions Both evidence resulting from controlled trials and real-world data suggest that digital therapeutics can result in relatively high levels of engagement and clinically meaningful sleep improvements. Key messages • This review demonstrate that both RCTs and real-world evidence support the efficacy of digitally-provided treatments for mitigating the impact and improve outcomes of patients with insomnia. • In a ever evolving scenario, where new digital solutions and therapeutics continuously enter the market, it is mandatory to constantly monitor the efficacy and safety of such innovations.

Impact of a digital therapeutic on adult asthma

Abstract Background Asthma impacts 334 million people globally. Medication adherence is estimated at 50% worldwide. Digital therapeutics (DTx) may improve medication adherence and health outcomes. Methods Prospective, single cohort observational study of 104 adults with asthma managed on inhaled corticosteroids. Subjects had 90-day access to Aptar Digital Health respiratory platform: HeroTracker to monitor adherence, spirometer for lung function, and BreatheSmart mobile app with real-time alerts. Primary outcomes: asthma control, rescue medication use. Secondary outcomes: controller medication adherence, patient feedback. Results Subjects completed Asthma Control Test (ACT) at baseline (T0); 96% (N = 100) completed ACT at 90 days (T1). Between T0 and T1, ACT scores increased significantly (baseline: 16.5 ± 4.7; ΔT0 to T1: + 2.8, 95% CI (2.0, 3.6), p-value &amp;lt;0.001); rescue medication use decreased 44% ((95% CI: 14.1, 63.5), p-value = 0.008); adherence to controller medication decreased 10.7% ((95% CI: 6.4, 15.1), p-value &amp;lt;0.001). 82.5% of subjects reported platform very/somewhat easy to use, 97.5% rated spirometer very/somewhat easy to use, 92.5% reported alerts very/somewhat helpful. Platform rating mean score = 7.825/10 (1-10; 10=high). Conclusions DTx may improve asthma control and decrease rescue medication use. T1 medication adherence was 17% higher than global medication adherence. Patient feedback was positive.

Culturally tailored digital therapeutic for substance use disorders with urban Indigenous people in the United States: A randomized controlled study

IntroductionIndigenous people experience health disparities, including higher rates of substance use disorders (SUDs). Digital therapeutics are a growing platform for treatment services and have the potential to expand access to culturally responsive interventions for Indigenous people. As one of the first randomized controlled trials for SUDs for American Indian and Alaska Native (AI/AN) adults, the aim of this study was to pilot test the efficacy of a culturally tailored intervention among urban Indigenous adults. MethodsThe study used a randomized controlled parallel design of 12 weeks of treatment-as-usual (TAU) (n = 26) versus TAU + Therapeutic Education System-Native Version (TES-NAV) (n = 27) with follow-up assessments at end of treatment and week 24 in an urban outpatient addiction treatment program for Native American adults. TAU consisted of individual/group counseling and cultural activities. The TES-NAV arm comprised TAU + 26 self-directed culturally tailored digital skills-based modules grounded in the community reinforcement approach with contingency management for abstinence and module completion. Primary outcome was longest consecutive weeks of abstinence from drugs and heavy drinking measured using self-report (Timeline Followback) and urine alcohol and drug toxicology screen during 12 weeks of treatment. Secondary outcomes were percent days abstinence during and posttreatment, coping strategies, social connectedness, and substance use and sexual risk behaviors. ResultsThe study enrolled fifty-three (52.8 % male) AI/AN adults seeking treatment for a SUD. Although the study did not detect a benefit of TAU+TES-NAV over TAU on the primary outcome (Median = 2 consecutive weeks of abstinence for both arms) at end of treatment (treatment effect: Z = −0.78, p = 0.437), TAU+TES-NAV participants did demonstrate significantly greater percent days of abstinence at the week 24 follow-up (69.3 % versus 49.0 % for TAU; t = 2.08, p = 0.045) and significantly greater change in social connectedness mean score, baseline to week 12 (Z = −2.66, p = 0.011), compared to TAU. The study detected no differences between treatment arms for coping strategies or risk behaviors. ConclusionThe addition of TES-NAV to TAU did not significantly improve consecutive weeks of abstinence from drugs or heavy drinking; however, several secondary findings suggest promise for a culturally tailored digital therapeutic SUD intervention among urban Indigenous people. Clinical Trials.Gov registration#NCT03363256.

Economic Evaluation Associated With Clinical-Grade Mobile App-Based Digital Therapeutic Interventions: Systematic Review.

Digital therapeutics (DTx), a class of software-based clinical interventions, are promising new technologies that can potentially prevent, manage, or treat a spectrum of medical disorders and diseases as well as deliver unprecedented portability for patients and scalability for health care providers. Their adoption and implementation were accelerated by the need for remote care during the COVID-19 pandemic, and awareness about their utility has rapidly grown among providers, payers, and regulators. Despite this, relatively little is known about the capacity of DTx to provide economic value in care. This study aimed to systematically review and summarize the published evidence regarding the cost-effectiveness of clinical-grade mobile app-based DTx and explore the factors affecting such evaluations. A systematic review of economic evaluations of clinical-grade mobile app-based DTx was conducted following the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) 2020 guidelines. Major electronic databases, including PubMed, Cochrane Library, and Web of Science, were searched for eligible studies published from inception to October 28, 2022. Two independent reviewers evaluated the eligibility of all the retrieved articles for inclusion in the review. Methodological quality and risk of bias were assessed for each included study. A total of 18 studies were included in this review. Of the 18 studies, 7 (39%) were nonrandomized study-based economic evaluations, 6 (33%) were model-based evaluations, and 5 (28%) were randomized clinical trial-based evaluations. The DTx intervention subject to assessment was found to be cost-effective in 12 (67%) studies, cost saving in 5 (28%) studies, and cost-effective in 1 (6%) study in only 1 of the 3 countries where it was being deployed in the final study. Qualitative deficiencies in methodology and substantial potential for bias, including risks of performance bias and selection bias in participant recruitment, were identified in several included studies. This systematic review supports the thesis that DTx interventions offer potential economic benefits. However, DTx economic analyses conducted to date exhibit important methodological shortcomings that must be addressed in future evaluations to reduce the uncertainty surrounding the widespread adoption of DTx interventions. PROSPERO International Prospective Register of Systematic Reviews CRD42022358616; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022358616.

Conceptualizing socially-assistive robots as a digital therapeutic tool in healthcare.

Artificial Intelligence (AI)-driven Digital Health (DH) systems are poised to play a critical role in the future of healthcare. In 2021, $57.2 billion was invested in DH systems around the world, recognizing the promise this concept holds for aiding in delivery and care management. DH systems traditionally include a blend of various technologies, AI, and physiological biomarkers and have shown a potential to provide support for individuals with various health conditions. Digital therapeutics (DTx) is a more specific set of technology-enabled interventions within the broader DH sphere intended to produce a measurable therapeutic effect. DTx tools can empower both patients and healthcare providers, informing the course of treatment through data-driven interventions while collecting data in real-time and potentially reducing the number of patient office visits needed. In particular, socially assistive robots (SARs), as a DTx tool, can be a beneficial asset to DH systems since data gathered from sensors onboard the robot can help identify in-home behaviors, activity patterns, and health status of patients remotely. Furthermore, linking the robotic sensor data to other DH system components, and enabling SAR to function as part of an Internet of Things (IoT) ecosystem, can create a broader picture of patient health outcomes. The main challenge with DTx, and DH systems in general, is that the sheer volume and limited oversight of different DH systems and DTxs is hindering validation efforts (from technical, clinical, system, and privacy standpoints) and consequently slowing widespread adoption of these treatment tools.

Cutting-Edge Technologies for Digital Therapeutics: A Review and Architecture Proposals for Future Directions

Digital therapeutics, evidence-based treatments delivered through software programs, are revolutionizing healthcare by utilizing cutting-edge computing technologies. Unlike conventional medical treatment methods, digital therapeutics are based on multiple information technologies, from data collection to analysis algorithms, and treatment support approaches. In this research, we provide a comprehensive overview of the latest technologies involved in the development of digital therapeutics and highlight specific technologies necessary for the future growth of the rapidly evolving digital therapeutics market. Furthermore, we present a system design of digital therapeutics for depression, currently being developed by our research team, to provide a detailed explanation of the technical process. Digital therapeutics require various technical supports, such as collecting user data in a security-enhanced medical environment, processing and analyzing the collected data, and providing personalized treatment methods to the user. The findings from this research will enable digital therapeutic companies to enhance their product performance, consequently bolstering their market competitiveness. Additionally, the research can be further extended to explore applicable methodologies at different stages of digital therapeutic environments.

Leveraging machine learning to examine engagement with a digital therapeutic.

Digital Therapeutics (DTx) are evidence-based software-driven interventions for the prevention, management, and treatment of medical disorders or diseases. DTx offer the unique ability to capture rich objective data about when and how a patient engages with a treatment. Not only can one measure the quantity of patient interactions with a digital treatment with high temporal precision, but one can also assess the quality of these interactions. This is particularly useful for treatments such as cognitive interventions, where the specific manner in which a patient engages may impact likelihood of treatment success. Here, we present a technique for measuring the quality of user interactions with a digital treatment in near-real time. This approach produces evaluations at the level of a roughly four-minute gameplay session (mission). Each mission required users to engage in adaptive and personalized multitasking training. The training included simultaneous presentation of a sensory-motor navigation task and a perceptual discrimination task. We trained a machine learning model to classify user interactions with the digital treatment to determine if they were "using it as intended" or "not using it as intended" based on labeled data created by subject matter experts (SME). On a held-out test set, the classifier was able to reliably predict the SME-derived labels (Accuracy = .94; F1 Score = .94). We discuss the value of this approach and highlight exciting future directions for shared decision-making and communication between caregivers, patients and healthcare providers. Additionally, the output of this technique can be useful for clinical trials and personalized intervention.

A cognitive behavioral digital therapeutic for anxiety and depression in patients with cancer: A decentralized randomized controlled trial.

1507 Background: Patients with cancer often experience clinically elevated levels of distress, including anxiety and depression. Psychological interventions, such as Cognitive Behavioral Stress Management (CBSM), have evidenced benefits on distress, quality of life, and long-term health outcomes, however, they are not widely available or easily accessible. Digitizing these interventions may be a means of democratizing access to cancer-focused and empirically-supported mental health care. Methods: This double-blind randomized controlled trial (RCT) compared the impact of a 10-module digitized CBSM app [attune] vs. a health education control app [cerena] on anxiety and depression symptoms in patients with cancer (n=449). Patients with non-metastatic (stage I-III) and hematological cancers who were receiving or recently (≤6 months) completed systemic treatment and reported a PROMIS-A T-Score &gt;60 were recruited to participate in this decentralized clinical trial through a nationwide online advertising campaign. The pre-specified primary outcome was change in anxiety symptoms (PROMIS-A) across conditions over time (week 0, 4, 8, and 12) in the intention-to-treat population analyzed using a linear mixed effects model with repeated measures. Secondary outcomes included change in depression symptoms (PROMIS-D) and global impression of change in anxiety and depression (PGI-C). Results: Patients in the study were 80.6% female, 76.5% white, and the mean (SD; range) age was 52.44 (11.46; 25-80) years. Compared to the control, attune participants showed significantly greater reductions in anxiety (β=-0.03; p=0.019) and depression (β=-0.02; p=0.042) symptoms over 12-weeks, and at end-of-study (week 12) there was a greater proportion of attune participants in the PROMIS-A (χ2=7.13; p=0.004) and PROMIS-D (χ2=3.53; p=0.035) mild-none symptom severity category. There were also significant group differences in PGI-C, with attune participants more likely to report ‘much’ or ‘very much’ improvement in their anxiety (χ2=31.76; p&lt;0.001) and depression symptoms (χ2=19.70; p&lt;0.001). Conclusions: Digital therapeutics have the potential to improve access to empirically supported psychological treatments for symptoms of anxiety and depression in patients with cancer. In this decentralized, double-blind RCT, we show that compared with a visually and functionally similar sham app, patients who used attune had significantly greater reductions in anxiety and depression symptoms over time. Moreover, at the end of the study, participants who used attune were significantly more likely to report their anxiety and depression symptoms were ‘much’ or ‘very much’ improved, indicating clinically meaningful change. Future work aims to explore implementation strategies to maximize benefit and accessibility of this cancer-specific digital therapeutic. Clinical trial information: NCT05227898 .

HPR157 Payer Perspectives on Health Insurance Coverage for Digital Therapeutics in the United States

The purpose of this study was to qualitatively evaluate factors affecting health insurance coverage and reimbursement of digital therapeutic (DTx) products by United States payers and coverage decision-makers.

The adoption and sustainability of digital therapeutics in justice systems: A pilot feasibility study.

This study explored whether participants with substance use disorder (SUD) would adopt and use a smart-phone app with a cognitive behavioral therapy program, weekly Brief Addiction Monitor (BAM) assessments, daily check-ins, tools to track sobriety and treatment, and other patient-centered resources. In addition, participants with SUD could access a social worker and peer support specialists. The study sought participants from two groups: those referred by a justice-related agency and participants who responded to outreach from the Addiction Policy Forum (APF). The Connections smart-phone app was offered to both groups. The study examined use of the app and social worker/peer recovery support services by participants who downloaded and used the app; those referred by a justice-related agency and those who self-referred through APF. The app provided primary data, including socio-demographics, referral status, dates of use, activities completed, and BAM scores. The app was offered to 1973 participants, 40% of whom downloaded it. Three groups emerged from among the 350 who used the app: those who used only the cognitive behavioral aspects of the app, those who used only the recovery support services offered, and those who used both the app and recovery support services. Looking at the two referral groups, the justice-referred group preferred telehealth recovery support services with the social worker; the self-referred group used the app and the app plus the recovery support services equally. Scores on the BAM improved across time. Justice-referred participants' protective behaviors improved more than those of the self-referred participants while self-referred participants' risk behaviors improved more than those of justice-referred participants. Older participants were more likely to use the app, and to report fewer risky behaviors, as measured by the BAM. Use of a digital therapeutic appears to support recovery of participants with SUD although many clients need and want the integration of social worker-driven recovery support services. Basically, the app can be an extension to personal services, but many people with SUD (particularly during COVID-19) crave human interaction. It also appears that those who seek assistance on their own, rather than being referred by a justice-related agency, may be more likely to benefit from digital therapeutics such as the Connections app.

Implementation and workflow strategies for integrating digital therapeutics for alcohol use disorders into primary care: a qualitative study

BackgroundAlcohol use disorders (AUD) are prevalent and often go untreated. Patients are commonly screened for AUD in primary care, but existing treatment programs are failing to meet demand. Digital therapeutics include novel mobile app-based treatment approaches which may be cost-effective treatment options to help fill treatment gaps. The goal of this study was to identify implementation needs and workflow design considerations for integrating digital therapeutics for AUD into primary care.MethodsWe conducted qualitative interviews with clinicians, care delivery leaders, and implementation staff (n = 16) in an integrated healthcare delivery system in the United States. All participants had experience implementing digital therapeutics for depression or substance use disorders in primary care. Interviews were designed to gain insights into adaptations needed to optimize existing clinical processes, workflows, and implementation strategies for use with alcohol-focused digital therapeutics. Interviews were recorded and transcribed and then analyzed using a rapid analysis process and affinity diagramming.ResultsQualitative themes were well represented across health system staff roles. Participants were enthusiastic about digital therapeutics for AUD, anticipated high patient demand for such a resource, and made suggestions for successful implementation. Key insights regarding the implementation of digital therapeutics for AUD and unhealthy alcohol use from our data include: (1) implementation strategy selection must be driven by digital therapeutic design and target population characteristics, (2) implementation strategies should seek to minimize burden on clinicians given the large numbers of patients with AUD who are likely to be interested in and eligible for digital therapeutics, and (3) digital therapeutics should be offered alongside many other treatment options to accommodate individual patients’ AUD severity and treatment goals. Participants also expressed confidence that previous implementation strategies used with other digital therapeutics such as clinician training, electronic health record supports, health coaching, and practice facilitation would be effective for the implementation of digital therapeutics for AUD.ConclusionsThe implementation of digital therapeutics for AUD would benefit from careful consideration of the target population. Optimal integration requires tailoring workflows to meet anticipated patient volume and designing workflow and implementation strategies to meet the unique needs of patients with varying AUD severity.

Fitterfly Diabetes CGM Digital Therapeutics Program for Glycemic Control and Weight Management in People With Type 2 Diabetes Mellitus: Real-world Effectiveness Evaluation.

Digital therapeutic platforms facilitate health care through patient-centered strategies based on multidisciplinary teams and shared decision-making. Such platforms can be used for developing a dynamic model of diabetes care delivery, which can help in improving glycemic control by promoting long-term behavior changes in people with diabetes. This study aims to evaluate the real-world effectiveness of the Fitterfly Diabetes CGM digital therapeutics program for improving glycemic control in people with type 2 diabetes mellitus (T2DM) after the completion of 90 days in the program. We analyzed deidentified data of 109 participants in the Fitterfly Diabetes CGM program. This program was delivered through the Fitterfly mobile app coupled with continuous glucose monitoring (CGM) technology. This program consists of 3 phases: the first phase is observation, wherein the patient's CGM readings are observed for 7 days (week 1); the second phase is the intervention; and the third phase aims at sustaining the lifestyle modification introduced during the second phase. The primary outcome of our study was the change in the participants' hemoglobin A1c (HbA1c) levels after program completion. We also evaluated the changes in participant weight and BMI after the program, changes in the CGM metrics in the initial 2 weeks of the program, and the effects of participant engagement in the program on improving their clinical outcomes. At the end of the 90 days of the program, the mean HbA1c levels, weight, and BMI of the participants were significantly reduced by 1.2% (SD 1.6%), 2.05 (SD 2.84) kg, and 0.74 (SD 1.02) kg/m2 from baseline values of 8.4% (SD 1.7%), 74.45 (SD 14.96) kg, and 27.44 (SD 4.69) kg/m2 in week 1, respectively (P<.001). The average blood glucose levels and time above range values showed a significant mean reduction by 16.44 (SD 32.05) mg/dL and 8.7% (SD 17.1%) in week 2 from week 1 baseline values of 152.90 (SD 51.63) mg/dL and 36.7% (SD 28.4%), respectively (P<.001 for both). Time in range values significantly improved by 7.1% (SD 16.7%) from a baseline value of 57.5% (SD 25%) in week 1 (P<.001). Of all the participants, 46.9% (50/109) showed HbA1c reduction ≥1% and 38.5% (42/109) showed weight loss ≥4%. The average number of times the mobile app was opened by each participant during the program was 108.80 (SD 127.91) times. Our study shows that participants in the Fitterfly Diabetes CGM program showed a significant improvement in their glycemic control and reduction in weight and BMI. They also showed a high level of engagement with the program. Weight reduction was significantly associated with higher participant engagement with the program. Thus, this digital therapeutic program can be considered as an effective tool for improving glycemic control in people with T2DM.

Assessing the Unmet Clinical Need and Opportunity for Digital Therapeutic Intervention in Schizophrenia: Perspective From People With Schizophrenia

AbstractIntroductionRecent research has highlighted the increasing ubiquity of smartphone ownership as well as the feasibility of digital interventions within schizophrenia. Digital therapeutics, a subset of digital interventions, have established standards for efficacy and safety and are subject to regulatory oversight as Software as a Medical Device. Here, we present data from a survey that assessed the opportunity and expectations that people with schizophrenia have for a digital therapeutic designed to be delivered on top of antipsychotic pharmacotherapy.MethodsSeventy-five people with schizophrenia completed a 10-item survey. Participants were between 22 and 55 years of age, reported no hospitalizations or medication changes within the past 3 months, and were currently seeing a psychiatrist. For each question, participants were asked to rank responses to provide a clear understanding of their preferences.ResultsPatients with schizophrenia reported the survey items that most impacted their daily life were: difficulty meeting new people (17%) and difficulty setting goals/completing activities in daily life and not being productive in their free time (both at 13%). The greatest unmet treatment needs reported by people with schizophrenia were: improving social skills (19%); reducing distress related to disease (19%); and being more productive in their free time (13%). In terms of expectations for what a digital therapeutic would include, the items reported as most important were: sharing progress with providers (13%); teaching ways to deal with symptoms (13%); and helping to set and achieve goals (12%).ConclusionMany of the top unmet needs that people with schizophrenia identified can be uniquely targeted by a digital therapeutic that augments their ongoing standard of care.FundingBoehringer Ingelheim International GmbH and CLICK Therapeutics, Inc.

STARS Adjunct Trial: Evidence for the Effectiveness of a Digital Therapeutic as Adjunct to Treatment With Medication in Pediatric ADHD

AbstractBackgroundTreatment of attention deficit hyperactivity disorder (ADHD) includes pharmacological and non-pharmacological interventions, both of which have demonstrated short-term efficacy. While efficacious, there are limitations to both modalities of treatment. Due partly to these limitations, there has been considerable interest in additional approaches to augmenting ADHD management. Digital therapeutics may offer improved access, minimal side effects, and low potential for abuse, while providing targeted treatment options for improving cognitive functions such as attention. AKL-T01 (EndeavorRx®) is the first and only FDA-cleared nonpharmacological prescription digital therapeutic delivered through a video game interface for the treatment of ADHD.ObjectiveThe objective is to summarize the data from a clinical trial in support of FDA clearance using AKL-T01 adjunctively in children currently taking stimulant medication for ADHD.MethodsThe STARS-Adjunct Trial was a multicenter, 12-week, open-label study of AKL-T01 in 206 children aged 8 to 14 years with a confirmed diagnosis of primarily inattentive or combined-type ADHD. The study included two cohorts: (1) subjects currently treated with ADHD medication (n=130) and (2) subjects not on any ADHD medication (n=76). Subjects had an ADHD Impairment Rating Scale (IRS) score ≥3 at baseline, and both cohorts used AKL-T01 for approximately 25 minutes per day, 5 days per week, over two 4-week treatment periods separated by a 4-week treatment pause.ResultsAKL-T01 significantly improved (lowered) ADHD-related impairment as measured with the IRS (clinician rated) after the first 4-week treatment in both cohorts (P&lt; 0.001). Results show that effects persist during a 4-week treatment pause and further improve with a second 4-week treatment period. A majority of parents and children indicated a perceived improvement in ability to pay attention after the trial. Most common device-related adverse events were decreased frustration tolerance, headache, and irritability which ranged from mild to moderate. No serious adverse events were reported.ConclusionsThis study adds to and extends the clinical evidence base for AKL-T01, a video game-based treatment for improving attentional functioning in 8–12-year-old children with ADHD. Continued evaluation of the effects of AKL-T01 on other important aspects of functioning, like academic and social functioning, health utilization, and health outcomes, would continue to add to the evidence base that the effects observed in this and previous studies have substantial clinical and functional impact.FundingAkili Interactive

Home blood pressure-lowering effect of digital therapeutics in hypertension: impact of body weight and salt intake.

Lifestyle modifications, including body weight reduction and salt restriction, help reduce blood pressure (BP). This study investigated the effects of body mass index (BMI) and salt intake on home BP reductions in unmedicated patients with hypertension receiving guideline-based lifestyle modification from doctors (control group) or with the addition of a digital therapeutics intervention. Data from the HERB Digital Hypertension 1 (HERB-DH1) pivotal trial were analyzed. Home BP was measured for 7 days before each study visit (baseline, and 4/8/12 weeks). Body weight was measured at each visit and salt intake questionnaire was answered at baseline and 12 weeks. This analysis included 302 patients with sufficient home BP monitoring data (digital therapeutics: 156; control group: 146). The reduction in morning home SBP from baseline to 12 weeks was significantly greater in the digital therapeutics vs. control group for patients with baseline BMI ≥ 25 kg/m2 and higher salt intake group (self-reported salt intake score ≥ 14) (-5.1 mmHg, p < 0.01). Patients in the digital therapeutics group who experienced a reduction in BMI and an improvement in salt intake score during the 12-week study also had a significantly greater reduction in morning home SBP compared with patients in the control group (-7.2 mmHg, p < 0.01). The digital therapeutic intervention reduced home BP the most in unmedicated patients with hypertension with high baseline BMI and salt intake score. Those with improvements in both BMI and salt intake during the digital therapeutics intervention achieved the greatest reduction in home BP vs. control.Clinical trial registration: Japan Registry of Clinical Trials (jRCT2032190148).

Developing Digital Therapeutics for Chronic Pain in Primary Care: A Qualitative Human-Centered Design Study of Providers' Motivations and Challenges.

Digital therapeutics are growing as a solution to manage pain for patients; yet, they are underused in primary care where over half of the patients with chronic pain seek care. Little is known about how to successfully engage primary care providers in recommending digital therapeutics to their patients. Exploring provider motivations in chronic pain management would potentially help to improve their engagement and inform the development of digital therapeutics. This study examined primary care providers' motivations for chronic pain management, including their strategies and challenges, to inform the future development of chronic pain-related digital therapeutics tailored to primary care settings. We conducted qualitative semistructured interviews with health care providers recruited from 3 primary care clinics in Washington and 1 clinic in Colorado between July and October 2021. The sample (N=11) included 7 primary care physicians, 2 behavioral health providers, 1 physician assistant, and 1 nurse. Most providers worked in clinics affiliated with urban academic health systems. Guided by the human-centered design approach and Christensen's Job-to-be-Done framework, we asked providers their goals and priorities in chronic pain management, their experiences with challenges and strategies used to care for patients, and their perceptions of applying digital therapeutics in clinical practice. Transcripts were analyzed using a thematic analysis approach. We found that primary care providers were motivated but challenged to strengthen the patient-provider alliance, provide team-based care, track and monitor patients' progress, and address social determinants of health in chronic pain management. Specifically, providers desired additional resources to improve patient-centered communication, pain education and counseling, and goal setting with patients. Providers also requested greater accessibility to multidisciplinary care team consultations and nonpharmacological pain treatments. When managing chronic pain at the population level, providers need infrastructure and systems to systematically track and monitor patients' pain and provide wraparound health and social services for underserved patients. Recommendations on digital therapeutic features that might address provider challenges in achieving these motivations were discussed. Given the findings, to engage primary care providers, digital therapeutics for chronic pain management need to strengthen the patient-provider alliance, increase access to nonpharmacological treatment options, support population health tracking and management, and provide equitable reach. Leveraging digital therapeutics in a feasible, appropriate, and acceptable way to aid primary care providers in chronic pain management may require multimodal features that address provider motivations at an individual care and clinic or system level.

Using Digital Health Technology to Prevent and Treat Diabetes.

Using Digital Health Technology to Prevent and Treat Diabetes.