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A special issue of Healthcare (ISSN 2227-9032). This special issue belongs to the section "TeleHealth and Digital Healthcare".

Deadline for manuscript submissions: closed (31 August 2023) | Viewed by 20585

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Special Issue Editor

Dr. Grzegorz Bulaj

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Guest Editor

Department of Medicinal Chemistry, Skaggs Pharmacy Institute, University of Utah, Salt Lake City, UT 84112, USA
Interests: digital health technologies; digital therapeutics; drug-digital combination therapies; mHealth; self-management; chronic diseases; pain; epilepsy; depression

Special Issue Information

Dear Colleagues,

Digital transformation in healthcare has observed an emergence of digital therapeutics (DTx, mobile medical apps, software as medical device) formulated to treat specific medical conditions. Due to the ability of DTx to deliver just-in-time, patient-centered therapeutic content, the integration of DTx with pharmacotherapies can advance precision medicine beyond genomics, epigenomics, and pharmacogenomics. Examples of challenges in the adoption of DTx in healthcare include attrition rates, scalability, reimbursement, cybersecurity risks, and data governance. Research and clinical development of DTx are paralleled with advances in wearables for digital biomarkers and other digital health technologies. Studies on the clinical efficacy and cost effectiveness of digital therapies support the evidence-based implementation of DTx in healthcare systems.

A unique feature of DTx projects is their cross-disciplinary nature, spanning areas such as computer science and engineering, clinical development, healthcare, public health, cybersecurity, business, and regulatory affairs. This Special Issue welcomes articles covering diverse aspects of advancing DTx, from early development stages through to implementation into healthcare. The goal of this Special Issue is to provide a cross-disciplinary dialogue platform to share ideas and results related to DTx. We invite research articles, reviews, perspectives, and other types of articles, describing design, clinical evaluations (pilot studies and pivotal RCTs), cost effectiveness, and implementation of DTx.

Dr. Grzegorz Bulaj
Guest Editor

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Healthcare is an international peer-reviewed open access semimonthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2700 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

digital therapeutics
mHealth
clinical studies (pilot and pivotal)
effectiveness
healthcare
cost effectiveness
implementation and scalability
regulatory affairs
reimbursement
cybersecurity risks and privacy

Published Papers (10 papers)

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Research

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10 pages, 741 KiB

Open AccessArticle

Pre-Attentional Effects on Global Precedence Processing in Children with Autism Spectrum Disorder and Those with Typical Development on a Tablet-Based Modified Navon’s Paradigm Task

by Yumi Ju, Soyoung Kang, Jin-Wook Chung and Jeh-Kwang Ryu

Healthcare 2023, 11(3), 372; https://doi.org/10.3390/healthcare11030372 - 28 Jan 2023

Cited by 1 | Viewed by 1324

Abstract

This study aimed to characterize the pre-attentional effects on global precedence processing in children with autism spectrum disorder (ASD) and those with typical development (TD). A sample of 17 participants, comprising eight children with ASD and nine TD children, were recruited for the study. A tablet-based assessment utilizing a global and local visual processing paradigm task was developed to investigate the participant’s abilities. The task consisted of verbal instructions to locate and touch either a global or local figure, presented in five conditions: neutral, congruent, and incongruent. The percentage of correct answers and reaction time (RT) for each task were measured and analyzed statistically. Results revealed that children with ASD exhibited statistically significant differences in both the percentage of correct scores and RT among various conditions, while TD children displayed differences in RT but not in the percentage of correct answers. These findings suggest that conflicting processes affect both behavioral and cognitive processes in children with ASD, and that cognitive effort is still involved for children with TD, but does not affect behavioral processes. In children with ASD, the RT was the shortest in the congruent (report local figure) condition; in children with TD, the RT was the shortest in the congruent (report global figure) condition. This implies that children with TD exhibit a pre-attentive effect on global precedence processing, while children with ASD do not. These visual-processing-function characteristics may aid in screening for visual perception problems in children with ASD. Full article

(This article belongs to the Special Issue Digital Therapeutics in Healthcare)

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11 pages, 975 KiB

Open AccessArticle

Development of a Digital Healthcare Management System for Lower-Extremity Amputees: A Pilot Study

by Jin Hong Kim, Yu Ri Kim, Mi Hyang Han, Ji Young Lee, Ji Sung Kim, Yong Cheol Kang, Seong Jun Yoon, Yunhee Chang, Gangpyo Lee and Nam Soon Cho

Healthcare 2023, 11(1), 106; https://doi.org/10.3390/healthcare11010106 - 29 Dec 2022

Viewed by 1918

Abstract

The research, which was designed as a “pre- and post-single group” study, included patients with lower-limb amputation and aimed to evaluate the effectiveness of self-directed physical-strength training and cardiovascular exercise using a novel digital healthcare management service three times a week for 12 weeks. Muscle strength, thigh circumference, lipid profile and glycated hemoglobin levels, pulmonary function, quality of life, and physical activity level were evaluated before and after the intervention, while satisfaction was measured after the study. Among the 14 included patients, the proportion of adherence to the physical-strength training and physical-strengthening activity were 85.2% and 75.8%, respectively. The level of satisfaction with the digital healthcare management system was high. Significant changes were observed in the muscle-strength tests (dominant grip power and muscle strength of knee flexion and extension of the intact side), thigh circumference, and glycated hemoglobin levels. Further, the quality-of-life score showed improvement, although without significant differences. Individualized exercise management using the novel digital healthcare management system for lower-limb amputees could induce interest in self-care and promote physical activity and healthy behavior. Through this effect, we can expect a reduction in the incidence of cardiovascular diseases, diabetes mellitus, dyslipidemia, and severe injuries from falling. Full article

(This article belongs to the Special Issue Digital Therapeutics in Healthcare)

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27 pages, 1131 KiB

Open AccessArticle

Efficacy and Feasibility of the Minimal Therapist-Guided Four-Week Online Audio-Based Mindfulness Program ‘Mindful Senses’ for Burnout and Stress Reduction in Medical Personnel: A Randomized Controlled Trial

by Pavinee Luangapichart, Nattha Saisavoey and Natee Viravan

Healthcare 2022, 10(12), 2532; https://doi.org/10.3390/healthcare10122532 - 14 Dec 2022

Cited by 3 | Viewed by 1608

Abstract

Previous online mindfulness-based interventions for burnout and stress reduction in medical personnel had limited effect size and high dropout rate, so we developed a new online mindfulness program ‘Mindful Senses (MS)’ with aims to increase effect size and lower dropout rate. To test its efficacy and feasibility, ninety medical personnel with moderate or high levels of burnout and stress from across Thailand were recruited and randomly allocated into Group A and Group B equally. Group A read psychological self-help articles (PSA) and attended MS program through smartphone application during weeks 1–4. Group B read PSA during weeks 1–4 and attended MS program during weeks 9–12. Burnout, stress, anxiety, depression, mindfulness, and quality of life were measured at baseline, week 4, and week 8 for both groups, and at weeks 12 and 16 for Group B. Group x time interaction was analyzed by repeated-measures ANOVA. The results showed that, compared to PSA only, MS + PSA had statistically significant improvement of burnout, stress, anxiety, depression, mindfulness, and quality of life with moderate-to-very large effect sizes at week 4 (d = 1.33, 1.42, 1.04, 1.14, 0.70, and 1.03, respectively) and moderate-to-large effect sizes at week 8 (d = 0.84, 0.98, 0.73, 0.73, 0.66, and 0.94, respectively). The dropout rate was 4.4%. In conclusion, the MS program has potential to be an alternative intervention for medical personnel suffering from burnout and stress. Full article

(This article belongs to the Special Issue Digital Therapeutics in Healthcare)

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14 pages, 518 KiB

Open AccessArticle

Long-Term Clinical Outcomes of a Remote Digital Musculoskeletal Program: An Ad Hoc Analysis from a Longitudinal Study with a Non-Participant Comparison Group

by Anabela C. Areias, Fabíola Costa, Dora Janela, Maria Molinos, Robert G. Moulder, Jorge Lains, Justin K. Scheer, Virgílio Bento, Vijay Yanamadala and Fernando Dias Correia

Healthcare 2022, 10(12), 2349; https://doi.org/10.3390/healthcare10122349 - 23 Nov 2022

Cited by 4 | Viewed by 2103

Abstract

Digital solutions have emerged as an alternative to conventional physiotherapy, particularly for chronic musculoskeletal pain (CMP) management; however, its long-term effects remain largely unexplored. This study focuses on patients reporting CMP, assessing 1-year clinical outcomes after a multimodal digital care program (DCP) versus non-participants, who enrolled in the program but never engaged in a single exercise session or partook of the educational content made available to them. In this longitudinal study ad-hoc analysis, pain and functionality outcomes at 1-year reassessment were studied, focusing on the odds of reaching minimal clinically important difference (MCID) and, overall average reduction in both outcomes. Healthcare utilization was additionally studied within the same period. From 867 individuals allocated to the study, 460 completed the 1-year reassessment (intervention group: 310; comparison group: 150). The intervention group presented sustained and greater pain reduction until 1-year reassessment than the comparison group, reflecting greater odds ratio of achieving the MCID both in pain and functionality (1.90 95% CI: 1.27–2.86, p = 0.002 and 2.02 95% CI: 1.31–3.12, p = 0.001, respectively). A lower healthcare utilization during the 1-year follow-up was observed in the intervention group than in the comparison group. This study suggests that a digital CMP program may have a lasting impact on improved pain and functionality in patients with CMP. Full article

(This article belongs to the Special Issue Digital Therapeutics in Healthcare)

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15 pages, 413 KiB

Open AccessArticle

Comparative Analysis of Quality of Life of Patients with Dermatological Problems: Teledermatology Versus Face-to-Face Dermatology

by Remedios Lopez-Liria, Antonio Lopez-Villegas, Maria Angeles Valverde-Martinez, Mercedes Perez-Heredia, Francisco Antonio Vega-Ramirez, Salvador Peiro and Cesar Leal-Costa

Healthcare 2022, 10(11), 2172; https://doi.org/10.3390/healthcare10112172 - 30 Oct 2022

Cited by 4 | Viewed by 1085

Abstract

The health-related quality of life (HRQoL) of the patients cared for with teledermatology (TD) services was analyzed as compared with face-to-face dermatology (F-F/D) at the hospital. This study was a controlled, non-blinded, intra-level, and multicenter randomized clinical trial, with a 6-month follow-up. A total of 450 patients were randomly assigned to two different groups. The Spanish version of the generic EuroQol-5-dimensions-5-Levels (EQ-5D-5L) questionnaire and the specific Skindex-29 questionnaire were used at 0 and 6 months. The number of primary care visits (2.24 TD; 1.68 F-F/D) and number of hospital visits (0.01 TD; 1.48 F-F/D) were statistically significant. It was observed that from month 0 onwards, the users included in the F-F/D group self-perceived a lower HRQoL than the users included in the TD group (Skindex-29 total: p ≤ 0.00; EQ-5D-5L VAS = p ≤ 0.00; EQ-5D-5L utilities = p ≤ 0.00). At the end of the study, the patients included in the F-F/D group still obtained lower scores in their perception of HRQoL, as compared to those included in the other type of follow-up (Skindex-29 total: p ≤ 0.00; EQ-5D-5L VAS = p ≤ 0.00; EQ-5D-5L utilities = p ≤ 0.00). TD was an effective diagnosis and follow-up tool. At the end of the study period, the HRQoL of the patients in both groups was significantly higher as compared to their baseline levels. Additionally, both the general and specific HRQoL perceived by the TD patients was higher than the F-F/D group from the start of the study. Full article

(This article belongs to the Special Issue Digital Therapeutics in Healthcare)

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16 pages, 1357 KiB

Open AccessEditor’s ChoiceArticle

Digital Care Programs for Chronic Hip Pain: A Prospective Longitudinal Cohort Study

by Dora Janela, Fabíola Costa, Anabela C. Areias, Maria Molinos, Robert G. Moulder, Jorge Lains, Virgílio Bento, Justin K. Scheer, Vijay Yanamadala, Steven P. Cohen and Fernando Dias Correia

Healthcare 2022, 10(8), 1595; https://doi.org/10.3390/healthcare10081595 - 22 Aug 2022

Cited by 4 | Viewed by 2499

Abstract

Chronic hip pain is a cause of disability worldwide. Digital interventions (DI) may promote access while providing proper management. This single-arm interventional study assesses the clinical outcomes and engagement of a completely remote multimodal DI in patients with chronic hip pain. This home-based DI consisted of exercise (with real-time biofeedback), education, and cognitive-behavioral therapy. Outcomes were calculated between baseline and program end, using latent growth curve analysis. Primary outcome was the Hip Disability and Osteoarthritis Outcome Score (HOOS). Secondary outcomes were pain, intent to undergo surgery, mental health, productivity, patient engagement (exercise sessions frequency), and satisfaction. Treatment response was assessed using a 30% pain change cut-off. A completion rate of 74.2% (396/534), alongside high patient engagement (2.9 exercise sessions/week, SD 1.1) and satisfaction (8.7/10, SD 1.6) were observed. Significant improvements were observed across all HOOS sub-scales (14.7–26.8%, p < 0.05), with 66.8% treatment responders considering pain. Marked improvements were observed in surgery intent (70.1%), mental health (54%), and productivity impairment (60.5%) (all p < 0.001). The high engagement and satisfaction reported after this DI, alongside the clinical outcome improvement, support the potential of remote care in the management of chronic hip conditions. Full article

(This article belongs to the Special Issue Digital Therapeutics in Healthcare)

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9 pages, 477 KiB

Open AccessCase Report

Using Immersive Virtual Reality Distraction to Reduce Fear and Anxiety before Surgery

by Araceli Flores, Hunter G. Hoffman, Maria Vicenta Navarro-Haro, Azucena Garcia-Palacios, Barbara Atzori, Sylvie Le May, Wadee Alhalabi, Mariana Sampaio, Miles R. Fontenot and Keira P. Mason

Healthcare 2023, 11(19), 2697; https://doi.org/10.3390/healthcare11192697 - 9 Oct 2023

Viewed by 1732

Abstract

Presurgical anxiety is very common and is often treated with sedatives. Minimizing or avoiding sedation reduces the risk of sedation-related adverse events. Reducing sedation can increase early cognitive recovery and reduce time to discharge after surgery. The current case study is the first to explore the use of interactive eye-tracked VR as a nonpharmacologic anxiolytic customized for physically immobilized presurgery patients. Method: A 44-year-old female patient presenting for gallbladder surgery participated. Using a within-subject repeated measures design (treatment order randomized), the participant received no VR during one portion of her preoperative wait and interactive eye-tracked virtual reality during an equivalent portion of time in the presurgery room. After each condition (no VR vs. VR), the participant provided subjective 0–10 ratings and state–trait short form Y anxiety measures of the amount of anxiety and fear she experienced during that condition. Results: As predicted, compared to treatment as usual (no VR), the patient reported having 67% lower presurgical anxiety during VR. She also experienced “strong fear” (8 out of 10) during no VR vs. “no fear” (0 out of 10) during VR. She reported a strong sense of presence during VR and zero nausea. She liked VR, she had fun during VR, and she recommended VR to future patients during pre-op. Interactive VR distraction with eye tracking was an effective nonpharmacologic technique for reducing anticipatory fear and anxiety prior to surgery. The results add to existing evidence that supports the use of VR in perioperative settings. VR technology has recently become affordable and more user friendly, increasing the potential for widespread dissemination into medical practice. Although case studies are scientifically inconclusive by nature, they help identify new directions for future larger, carefully controlled studies. VR sedation is a promising non-drug fear and anxiety management technique meriting further investigation. Full article

(This article belongs to the Special Issue Digital Therapeutics in Healthcare)

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46 pages, 886 KiB

Open AccessStudy Protocol

Monitoring and Predicting Health Status in Neurological Patients: The ALAMEDA Data Collection Protocol

by Alexandru Sorici, Lidia Băjenaru, Irina Georgiana Mocanu, Adina Magda Florea, Panagiotis Tsakanikas, Athena Cristina Ribigan, Ludovico Pedullà and Anastasia Bougea

Healthcare 2023, 11(19), 2656; https://doi.org/10.3390/healthcare11192656 - 29 Sep 2023

Viewed by 1012

Abstract

(1) Objective: We explore the predictive power of a novel stream of patient data, combining wearable devices and patient reported outcomes (PROs), using an AI-first approach to classify the health status of Parkinson’s disease (PD), multiple sclerosis (MS) and stroke patients (collectively named PMSS). (2) Background: Recent studies acknowledge the burden of neurological disorders on patients and on the healthcare systems managing them. To address this, effort is invested in the digital transformation of health provisioning for PMSS patients. (3) Methods: We introduce the data collection journey within the ALAMEDA project, which continuously collects PRO data for a year through mobile applications and supplements them with data from minimally intrusive wearable devices (accelerometer bracelet, IMU sensor belt, ground force measuring insoles, and sleep mattress) worn for 1–2 weeks at each milestone. We present the data collection schedule and its feasibility, the mapping of medical predictor variables to wearable device capabilities and mobile application functionality. (4) Results: A novel combination of wearable devices and smartphone applications required for the desired analysis of motor, sleep, emotional and quality-of-life outcomes is introduced. AI-first analysis methods are presented that aim to uncover the prediction capability of diverse longitudinal and cross-sectional setups (in terms of standard medical test targets). Mobile application development and usage schedule facilitates the retention of patient engagement and compliance with the study protocol. Full article

(This article belongs to the Special Issue Digital Therapeutics in Healthcare)

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15 pages, 664 KiB

Open AccessEditor’s ChoiceSystematic Review

Digital Health for Patients Undergoing Cardiac Surgery: A Systematic Review

by Kevin A. Wu, Sameer Kunte, Shashank Rajkumar, Vishal Venkatraman, Grace Kim, Samantha Kaplan, Syed Omar Anwar-Hashmi, Julie Doberne, Tom C. Nguyen and Shivanand P. Lad

Healthcare 2023, 11(17), 2411; https://doi.org/10.3390/healthcare11172411 - 28 Aug 2023

Cited by 2 | Viewed by 1410

Abstract

Digital health interventions have shown promise in improving patient outcomes and experiences in various healthcare settings. However, their effectiveness in the context of cardiac surgery remains uncertain. This systematic review aims to evaluate the existing evidence on the use of digital health interventions for patients undergoing cardiac surgery. A comprehensive search of PubMed MEDLINE, Elsevier EMBASE, Elsevier Scopus databases, and ClinicalTrials.gov was conducted to identify relevant studies published up to the present. Studies that examined the effects of digital health interventions, including mobile applications and web-based interventions, on perioperative care and patient outcomes in cardiac surgery were included. The data were extracted and synthesized to provide a comprehensive overview of the findings. The search yielded 15 studies composed of 4041 patients, analyzing the feasibility and implementation of mobile or internet applications for patients undergoing cardiac surgery. The studies included the use of mobile applications (ManageMySurgery, SeamlessMD, mHeart, Telediaglog, ExSed, Soulage Tavie, Heart Health application, and Mayo Clinic Health Connection) and web-based interventions (Heartnet and Active Heart). The findings indicated that these digital health interventions were associated with improved patient engagement, satisfaction, and reduced healthcare utilization. Patients reported finding the interventions helpful in their recovery process, and there was evidence of enhanced symptom monitoring and timely intervention. The completion rates of modules varied depending on the phase of care, with higher engagement observed during the acute phase. Interest in using digital health applications was expressed by patients, regardless of age, gender, or complexity of the cardiac defect. The results demonstrated that web-based interventions resulted in improvements in mental health, quality of life, and eHealth literacy. This systematic review highlights the potential benefits of digital health interventions in the context of cardiac surgery. Further research, including randomized controlled trials, is needed to establish the effectiveness, feasibility, and generalizability of digital health interventions in cardiac surgery. Full article

(This article belongs to the Special Issue Digital Therapeutics in Healthcare)

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18 pages, 3182 KiB

Open AccessPerspective

Digital Therapeutics (DTx) Expand Multimodal Treatment Options for Chronic Low Back Pain: The Nexus of Precision Medicine, Patient Education, and Public Health

by Aarushi Rohaj and Grzegorz Bulaj

Healthcare 2023, 11(10), 1469; https://doi.org/10.3390/healthcare11101469 - 18 May 2023

Cited by 5 | Viewed by 4063

Abstract

Digital therapeutics (DTx, software as a medical device) provide personalized treatments for chronic diseases and expand precision medicine beyond pharmacogenomics-based pharmacotherapies. In this perspective article, we describe how DTx for chronic low back pain (CLBP) can be integrated with pharmaceutical drugs (e.g., NSAIDs, opioids), physical therapy (PT), cognitive behavioral therapy (CBT), and patient empowerment. An example of an FDA-authorized DTx for CLBP is RelieVRx, a prescription virtual reality (VR) app that reduces pain severity as an adjunct treatment for moderate to severe low back pain. RelieVRx is an immersive VR system that delivers at-home pain management modalities, including relaxation, self-awareness, pain distraction, guided breathing, and patient education. The mechanism of action of DTx is aligned with recommendations from the American College of Physicians to use non-pharmacological modalities as the first-line therapy for CLBP. Herein, we discuss how DTx can provide multimodal therapy options integrating conventional treatments with exposome-responsive, just-in-time adaptive interventions (JITAI). Given the flexibility of software-based therapies to accommodate diverse digital content, we also suggest that music-induced analgesia can increase the clinical effectiveness of digital interventions for chronic pain. DTx offers opportunities to simultaneously address the chronic pain crisis and opioid epidemic while supporting patients and healthcare providers to improve therapy outcomes. Full article

(This article belongs to the Special Issue Digital Therapeutics in Healthcare)

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