Prototyping Apps for the Management of Sleep, Fatigue, and Behavioral Health in Austere Far-Forward Environments: Development Study.

BACKGROUND: Military service inherently includes frequent periods of high-stress training, operational tempo, and sustained deployments to austere far-forward environments. These occupational requirements can contribute to acute and chronic sleep disruption, fatigue, and behavioral health challenges related to acute and chronic stress and disruption of team dynamics. To date, there is no centralized mobile health platform that supports self- and supervised detection, monitoring, and management of sleep and behavioral health issues in garrison and during and after deployments. OBJECTIVE: The objective of this study was to adapt a clinical decision support platform for use outside clinical settings, in garrison, and during field exercises by medics and soldiers to monitor and manage sleep and behavioral health in operational settings. METHODS: To adapt an existing clinical decision support digital health platform, we first gathered system, content, and context-related requirements for a sleep and behavioral health management system from experts. Sleep and behavioral health assessments were then adapted for prospective digital data capture. Evidence-based and operationally relevant educational and interventional modules were formatted for digital delivery. These modules addressed the management and mitigation of sleep, circadian challenges, fatigue, stress responses, and team communication. Connectivity protocols were adapted to accommodate the absence of cellular or Wi-Fi access in deployed settings. The resulting apps were then tested in garrison and during 2 separate field exercises. RESULTS: Based on identified requirements, 2 Android smartphone apps were adapted for self-monitoring and management for soldiers (Soldier app) and team supervision and intervention by medics (Medic app). A total of 246 soldiers, including 28 medics, received training on how to use the apps. Both apps function as expected under conditions of limited connectivity during field exercises. Areas for future technology enhancement were also identified. CONCLUSIONS: We demonstrated the feasibility of adapting a clinical decision support platform into Android smartphone-based apps to collect, save, and synthesize sleep and behavioral health data, as well as share data using adaptive data transfer protocols when Wi-Fi or cellular data are unavailable. The AIRE (Autonomous Connectivity Independent System for Remote Environments) prototype offers a novel self-management and supervised tool to augment capabilities for prospective monitoring, detection, and intervention for emerging sleep, fatigue, and behavioral health issues that are common in military and nonmilitary high-tempo occupations (eg, submarines, long-haul flights, space stations, and oil rigs) where medical expertise is limited.

The Effect of Tailored, Daily, Smartphone Feedback to Lifestyle Self-Monitoring on Weight Loss at 12 Months: the SMARTER Randomized Clinical Trial.

BACKGROUND: Self-monitoring (SM) is the centerpiece of behavioral weight loss treatment, but the efficacy of smartphone-delivered SM feedback (FB) has not been tested in large, long-term, randomized trials. OBJECTIVE: The aim of this study was to establish the efficacy of providing remote FB to diet, physical activity (PA), and weight SM on improving weight loss outcomes when comparing the SM plus FB (SM+FB) condition to the SM-only condition in a 12-month randomized controlled trial. The study was a single-site, population-based trial that took place in southwestern Pennsylvania, USA, conducted between 2018 and 2021. Participants were smartphone users age ≥18 years, able to engage in moderate PA, with a mean BMI between 27 and 43 kg/m2. METHODS: All participants received a 90-minute, one-to-one, in-person behavioral weight loss counseling session addressing behavioral strategies, establishing participants' dietary and PA goals, and instructing on use of the PA tracker (Fitbit Charge 2), smart scale, and diet SM app. Only SM+FB participants had access to an investigator-developed smartphone app that read SM data, in which an algorithm selected tailored messages sent to the smartphone up to 3 times daily. The SM-only participants did not receive any tailored FB based on SM data. The primary outcome was percent weight change from baseline to 12 months. Secondary outcomes included engagement with digital tools (eg, monthly percentage of FB messages opened and monthly percentage of days adherent to the calorie goal). RESULTS: Participants (N=502) were on average 45.0 (SD 14.4) years old with a mean BMI of 33.7 (SD 4.0) kg/m2. The sample was 79.5% female (n=399/502) and 82.5% White (n=414/502). At 12 months, retention was 78.5% (n=394/502) and similar by group (SM+FB: 202/251, 80.5%; SM: 192/251, 76.5%; P=.28). There was significant percent weight loss from baseline in both groups (SM+FB: -2.12%, 95% CI -3.04% to -1.21%, P<.001; SM: -2.39%, 95% CI -3.32% to -1.47%; P<.001), but no difference between the groups (-0.27%; 95% CI -1.57% to 1.03%; t =-0.41; P=.68). Similarly, 26.3% (66/251) of the SM+FB group and 29.1% (73/251) of the SM group achieved ≥5% weight loss (chi-square value=0.49; P=.49). A 1% increase in FB messages opened was associated with a 0.10 greater percent weight loss at 12 months (b=-0.10; 95% CI -0.13 to -0.07; t =-5.90; P<.001). A 1% increase in FB messages opened was associated with 0.12 greater percentage of days adherent to the calorie goal per month (b=0.12; 95% CI 0.07-0.17; F=22.19; P<.001). CONCLUSIONS: There were no significant between-group differences in weight loss; however, the findings suggested that the use of commercially available digital SM tools with or without FB resulted in a clinically significant weight loss in over 25% of participants. Future studies need to test additional strategies that will promote greater engagement with digital tools. TRIAL REGISTRATION: Clinicaltrials.gov NCT03367936; https://clinicaltrials.gov/ct2/show/NCT03367936.

Clinical Feasibility of a Just-in-Time Adaptive Intervention App (iREST) as a Behavioral Sleep Treatment in a Military Population: Feasibility Comparative Effectiveness Study.

BACKGROUND: Although evidence-based cognitive behavioral sleep treatments have been shown to be safe and effective, these treatments have limited scalability. Mobile health tools can address this scalability challenge. iREST, or interactive Resilience Enhancing Sleep Tactics, is a mobile health platform designed to provide a just-in-time adaptive intervention (JITAI) in the assessment, monitoring, and delivery of evidence-based sleep recommendations in a scalable and personalized manner. The platform includes a mobile phone-based patient app linked to a clinician portal. OBJECTIVE: The first aim of the pilot study was to evaluate the effectiveness of JITAI using the iREST platform for delivering evidence-based sleep interventions in a sample of military service members and veterans. The second aim was to explore the potential effectiveness of this treatment delivery form relative to habitual in-person delivery. METHODS: In this pilot study, military service members and veterans between the ages of 18 and 60 years who reported clinically significant service-related sleep disturbances were enrolled as participants. Participants were asked to use iREST for a period of 4 to 6 weeks during which time they completed a daily sleep/wake diary. Through the clinician portal, trained clinicians offered recommendations consistent with evidence-based behavioral sleep treatments on weeks 2 through 4. To explore potential effectiveness, self-report measures were used, including the Insomnia Severity Index (ISI), the Pittsburgh Sleep Quality Index (PSQI), and the PSQI Addendum for Posttraumatic Stress Disorder. RESULTS: A total of 27 participants completed the posttreatment assessments. Between pre- and postintervention, clinically and statistically significant improvements in primary and secondary outcomes were detected (eg, a mean reduction on the ISI of 9.96, t26=9.99, P<.001). At posttreatment, 70% (19/27) of participants met the criteria for treatment response and 59% (16/27) achieved remission. Comparing these response and remission rates with previously published results for in-person trials showed no significant differences. CONCLUSION: Participants who received evidence-based recommendations from their assigned clinicians through the iREST platform showed clinically significant improvements in insomnia severity, overall sleep quality, and disruptive nocturnal disturbances. These findings are promising, and a larger noninferiority clinical trial is warranted.

Pilot feasibility of an mHealth system for conducting ecological momentary assessment of mood-related symptoms following traumatic brain injury.

OBJECTIVE: This study assessed pilot feasibility and validity of a mobile health (mHealth) system for tracking mood-related symptoms after traumatic brain injury (TBI). DESIGN: A prospective, repeated measures design was used to assess compliance with daily ecological momentary assessments (EMA) conducted via a smartphone application over an 8-week period. METHODS: An mHealth system was developed specifically for individuals with TBI and utilized previously validated tools for depressive and anxiety symptoms (Patient Health Questionnaire-9, Generalized Anxiety Disorder-7). Feasibility was assessed in 20 community-dwelling adults with TBI via an assessment of compliance, satisfaction and usability of the smartphone applications. The authors also developed and implemented a clinical patient safety management mechanism for those endorsing suicidality. RESULTS: Participants correctly completed 73.4% of all scheduled assessments, demonstrating good compliance. Daily assessments took <2 minutes to complete. Participants reported high satisfaction with smartphone applications (6.3 of 7) and found them easy to use (6.2 of 7). Comparison of assessments obtained via telephone-based interview and EMA demonstrated high correlations (r = 0.81-0.97), supporting the validity of conducting these assessments via smartphone application in this population. CONCLUSIONS: EMA conducted via smartphone demonstrates initial feasibility among adults with TBI and presents numerous opportunities for long-term monitoring of mood-related symptoms in real-world settings.

Usability and reliability of a remotely administered adult autism assessment, the autism diagnostic observation schedule (ADOS) module 4.

INTRODUCTION: The Autism Diagnostic Observation Schedule (ADOS) Module 4 is an autism assessment designed for verbally fluent adolescents and adults. Because of a shortage of available clinical expertise, it can be difficult for adults to receive a proper autism spectrum disorder (ASD) diagnostic assessment. A potential option to address this shortage is remote assessment. The objective of this study was to examine the feasibility, usability, and reliability of administering the ADOS Module 4 remotely using the Versatile and Integrated System for Telerehabilitation (VISYTER). MATERIALS AND METHODS: VISYTER consists of computer stations at the client site and clinician site for video communication and a Web portal for managing and coordinating the assessment process. Twenty-three adults with an ASD diagnosis participated in a within-subject crossover design study in which both a remote ADOS and a face-to-face ADOS were administered. After completing the remote ADOS, participants completed a satisfaction survey. RESULTS: Participant satisfaction with the remote ADOS delivery system was high. The kappa value was greater than 0.61 on 21 of 31 ADOS items. There was substantial agreement on ADOS classification (i.e., diagnosis) between assessments delivered face-to-face versus assessments delivered remotely (interclass coefficient=0.92). Non-agreement may have been due to outside factors or practice effect despite a washout period. CONCLUSIONS: The results of this study demonstrate that an autism assessment designed to be delivered face to face can be administered remotely using an integrated Web-based system with high levels of usability and reliability.

An integrated telehealth system for remote administration of an adult autism assessment.

We developed a telehealth system to administer an autism assessment remotely. The remote assessment system integrates videoconferencing, stimuli presentation, recording, image and video presentation, and electronic assessment scoring into an intuitive software platform. This is an advancement over existing technologies used in telemental health, which currently require several devices. The number of children, adolescents, and adults with autism spectrum disorders (ASDs) has increased dramatically over the past 20 years and is expected to continue to increase in coming years. In general, there are not many clinicians trained in either the diagnosis or treatment of adults with ASD. Given the number of adults with autism in need, a remote assessment system can potentially provide a solution to the lack of trained clinicians. The goal is to make the remote assessment system as close to face-to-face assessment as possible, yet versatile enough to support deployment in underserved areas. The primary challenge to achieving this goal is that the assessment requires social interaction that appears natural and fluid, so the remote system needs to be able to support fluid natural interaction. For this study we developed components to support this type of interaction and integrated these components into a system capable of supporting the entire autistic assessment protocol. We then implemented the system and evaluated the system on real patients. The results suggest that we have achieved our goal in developing a system with high-quality interaction that is easy to use.

Effect of tailored, daily feedback with lifestyle self-monitoring on weight loss: The SMARTER randomized clinical trial.

OBJECTIVE: This study aimed to test the efficacy of self-monitoring and feedback (SM+FB) versus SM without FB (SM) in a behavioral weight-loss intervention at 6 months. METHODS: This was a randomized clinical trial. Eligibility criteria included the following: ≥18 years of age, BMI ≥ 27 and ≤43, smartphone user, and ability to engage in moderate physical activity. All participants received a 90-minute 1:1 counseling session, a Fitbit Charge 2, and a digital scale for SM. SM+FB participants were provided access to a customized smartphone application that provided three daily FB messages. The primary outcome was percentage of weight change from 0 to 6 months. RESULTS: The sample (N = 502) was 45 (SD 14.4) years old, BMI was 33.7 (SD 4.00) kg/m2 , 79.5% of participants were female (n = 399), and 84.3% were White (n = 423). At 6 months, there was 85.86% retention and a significant percentage of weight change in both groups (SM+FB: -3.16%, 95% CI: -3.85% to -2.47%, p < 0.0001; SM: -3.20%, 95% CI: -3.86% to -2.54%, p < 0.0001) but no significant between-group mean difference (-0.04%, 95% CI: -0.99% to 0.91%, p = 0.940). A ≥5% weight loss was achieved by 31.9% of the SM+FB group and 28.3% of the SM group. CONCLUSIONS: There was no significant between-group difference in weight loss at 6 months.

The SMARTER Trial: Design of a trial testing tailored mHealth feedback to impact self-monitoring of diet, physical activity, and weight.

BACKGROUND: Self-monitoring food intake and physical activity (PA) is positively related to weight loss and the addition of feedback (FB) messages has been shown to reinforce behavior change. Moreover, the more immediate the delivery of reinforcing FB messages, the more likely they will promote the desired behaviors. PURPOSE: Describe design and rationale of SMARTER, a National Institute of Heart, Lung, and Blood (NHLBI)-sponsored randomized, controlled trial, which compares the differential efficacy of two weight loss treatments among 530 adults, ages 18 and older. METHODS: Single-site, 2-group design trial with subjects randomized 1:1 to either: 1) self-monitoring (SM), where participants self-monitor diet, PA, and weight using a commercial smartphone application (app); or 2) SM + FB, where participants self-monitor and receive real-time, tailored feedback (FB) as pop-up messages up to 3 times/day for 12 months. Daily FB messages address diet and PA behaviors and a weekly FB message addresses self-weighing. We hypothesize that subjects assigned to SM + FB will show greater weight loss at 6 and 12 months and greater sustained engagement in the program than the SM group, measured by adherence to the study's lifestyle and SM protocol. We will explore temporal relationships of the frequency, timing, and type of FB delivered and subsequent lifestyle behaviors through examination of serially collected real-time SM (diet, PA, weight) data over 12 months. CONCLUSIONS: If efficacious, this fully scalable intervention could be efficiently translated and disseminated to reach large numbers of individuals through commercial apps at lower cost than existing in-person weight loss programs.

Development of a Just-in-Time Adaptive mHealth Intervention for Insomnia: Usability Study.

BACKGROUND: Healthy sleep is a fundamental component of physical and brain health. Insomnia, however, is a prevalent sleep disorder that compromises functioning, productivity, and health. Therefore, developing efficient treatment delivery methods for insomnia can have significant societal and personal health impacts. Cognitive behavioral therapy for insomnia (CBTI) is the recommended first-line treatment of insomnia but access is currently limited for patients, since treatment must occur in specialty sleep clinics, which suffer from an insufficient number of trained clinicians. Smartphone-based interventions offer a promising means for improving the delivery of CBTI. Furthermore, novel features such as real-time monitoring and assessment, personalization, dynamic adaptations of the intervention, and context awareness can enhance treatment personalization and effectiveness, and reduce associated costs. Ultimately, this "Just in Time Adaptive Intervention" for insomnia-an intervention approach that is acceptable to patients and clinicians, and is based on mobile health (mHealth) platform and tools-can significantly improve patient access and clinician delivery of evidence-based insomnia treatments. OBJECTIVE: This study aims to develop and assess the usability of a Just in Time Adaptive Intervention application platform called iREST ("interactive Resilience Enhancing Sleep Tactics") for use in behavioral insomnia interventions. iREST can be used by both patients and clinicians. METHODS: The development of iREST was based on the Iterative and Incremental Development software development model. Requirement analysis was based on the case study's description, workflow and needs, clinician inputs, and a previously conducted BBTI military study/implementation of the Just in Time Adaptive Intervention architecture. To evaluate the usability of the iREST mHealth tool, a pilot usability study was conducted. Additionally, this study explores the feasibility of using an off-the-shelf wearable device to supplement the subjective assessment of patient sleep patterns. RESULTS: The iREST app was developed from the mobile logical architecture of Just in Time Adaptive Intervention. It consists of a cross-platform smartphone app, a clinician portal, and secure 2-way communications platform between the app and the portal. The usability study comprised 19 Active Duty Service Members and Veterans between the ages of 18 and 60. Descriptive statistics based on in-app questionnaires indicate that on average, 12 (mean 12.23, SD 8.96) unique devices accessed the clinician portal per day for more than two years, while the app was rated as "highly usable", achieving a mean System Usability Score score of 85.74 (SD 12.37), which translates to an adjective rating of "Excellent". The participants also gave high scores on "ease of use and learnability" with an average score of 4.33 (SD 0.65) on a scale of 1 to 5. CONCLUSIONS: iREST provides a feasible platform for the implementation of Just in Time Adaptive Intervention in mHealth-based and remote intervention settings. The system was rated highly usable and its cross-platformness made it readily implemented within the heavily segregated smartphone market. The use of wearables to track sleep is promising; yet the accuracy of this technology needs further improvement. Ultimately, iREST demonstrates that mHealth-based Just in Time Adaptive Intervention is not only feasible, but also works effectively.