Novel Trial Design: CHIEF-HF.

BACKGROUND: The expense of clinical trials mandates new strategies to efficiently generate evidence and test novel therapies. In this context, we designed a decentralized, patient-centered randomized clinical trial leveraging mobile technologies, rather than in-person site visits, to test the efficacy of 12 weeks of canagliflozin for the treatment of heart failure, regardless of ejection fraction or diabetes status, on the reduction of heart failure symptoms. METHODS: One thousand nine hundred patients will be enrolled with a medical record-confirmed diagnosis of heart failure, stratified by reduced (≤40%) or preserved (>40%) ejection fraction and randomized 1:1 to 100 mg daily of canagliflozin or matching placebo. The primary outcome will be the 12-week change in the total symptom score of the Kansas City Cardiomyopathy Questionnaire. Secondary outcomes will be daily step count and other scales of the Kansas City Cardiomyopathy Questionnaire. RESULTS: The trial is currently enrolling, even in the era of the coronavirus disease 2019 (COVID-19) pandemic. CONCLUSIONS: CHIEF-HF (Canagliflozin: Impact on Health Status, Quality of Life and Functional Status in Heart Failure) is deploying a novel model of conducting a decentralized, patient-centered, randomized clinical trial for a new indication for canagliflozin to improve the symptoms of patients with heart failure. It can model a new method for more cost-effectively testing the efficacy of treatments using mobile technologies with patient-reported outcomes as the primary clinical end point of the trial. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04252287.

Can social isolation caused by physical distance in people with psychosis be overcome through a Phone Pal?

The current pandemic has forced many people into self-isolation and to practice social distancing. When people are physically isolated and distant from each other, technology may play a fundamental role by enabling social connection and reducing feelings of loneliness caused by this prolonged social isolation. In response to the COVID-19 pandemic, many mental health services worldwide have had to shift their routine face-to-face outpatient appointments to remote telepsychiatry encounters. The increased pressure on mental health services highlights the importance of community-led health-promotion interventions, which can contribute to preventing mental illness or their relapses, and to reduce the burden on health services. Patients with psychosis are particularly socially isolated, have sedentary lifestyles, and commonly face stigma and discrimination from the general population. At the same time, patients with psychosis value technology, are interested in, use and own smart-phones to digitally connect, and are satisfied with their use. Thus, among psychosocial interventions, a helpful resource may be "Phone Pal," a complex intervention which facilitates remote communication between volunteers and socially isolated patients with psychosis through different smart-phone tools. While "Phone Pal" has been originally developed for people with psychosis, it may also be useful to the wider population, helping to overcome the social isolation caused by physical distancing, particularly in these times of widespread isolation. "Phone Pal" may be a potential public health resource for society, providing important support to those that may need it the most, and possibly benefit most from it.

Implantable devices for heart failure monitoring.

Heart failure (HF) is associated with considerable morbidity and mortality. The increasing prevalence of HF and inpatient HF hospitalization has a considerable burden on healthcare cost and utilization. The recognition that hemodynamic changes in pulmonary artery pressure (PAP) and left atrial pressure precede the signs and symptoms of HF has led to interest in hemodynamic guided HF therapy as an approach to allow earlier intervention during a heart failure decompensation. Remote patient monitoring (RPM) utilizing telecommunication, cardiac implantable electronic device parameters and implantable hemodynamic monitors (IHM) have largely failed to demonstrate favorable outcomes in multicenter trials. However, one positive randomized clinical trial testing the CardioMEMS device (followed by Food and Drug Administration approval) has generated renewed interest in PAP monitoring in the HF population to decrease hospitalization and improve quality of life. The COVID-19 pandemic has also stirred a resurgence in the utilization of telehealth to which RPM using IHM may be complementary. The cost effectiveness of these monitors continues to be a matter of debate. Future iterations of devices aim to be smaller, less burdensome for the patient, less dependent on patient compliance, and less cumbersome for health care providers with the integration of artificial intelligence coupled with sophisticated data management and interpretation tools. Currently, use of IHM may be considered in advanced heart failure patients with the support of structured programs.

Application of telemedicine in the COVID-19 epidemic: An analysis of Gansu Province in China.

This paper analyzes the application of various telemedicine services in Gansu Province, China during the COVID-19 epidemic, and summarizes the experiences with these services. In addition, the satisfaction levels of patients and doctors with the application of telemedicine in COVID-19 were investigated, the deficiencies of telemedicine in Gansu were determined, and recommendations for modification were proposed. Coronavirus Disease 2019 (COVID-19) has broken out in China, and Gansu Province in Northwest of China has not been spared. To date, there are 91 local COVID-19 cases and 42 imported cases. 109 hospitals were selected as designated hospitals during the COVID-19 outbreak, and most of them were secondary hospitals. However, it was unsatisfactory that the ability of medical services is relatively low in most of secondary hospitals and primary hospitals. Therefore, we helped the secondary hospitals cope with COVID-19 by means of remote consultation, long-distance education, telemedicine question and answer (Q&A). Our practical experience shows that telemedicine can be widely used during the COVID-19 epidemic, especially in developing countries and areas with lagging medical standards.

Real time remote symptom monitoring during chemotherapy for cancer: European multicentre randomised controlled trial (eSMART).

OBJECTIVE: To evaluate effects of remote monitoring of adjuvant chemotherapy related side effects via the Advanced Symptom Management System (ASyMS) on symptom burden, quality of life, supportive care needs, anxiety, self-efficacy, and work limitations. DESIGN: Multicentre, repeated measures, parallel group, evaluator masked, stratified randomised controlled trial. SETTING: Twelve cancer centres in Austria, Greece, Norway, Republic of Ireland, and UK. PARTICIPANTS: 829 patients with non-metastatic breast cancer, colorectal cancer, Hodgkin's disease, or non-Hodgkin's lymphoma receiving first line adjuvant chemotherapy or chemotherapy for the first time in five years. INTERVENTION: Patients were randomised to ASyMS (intervention; n=415) or standard care (control; n=414) over six cycles of chemotherapy. MAIN OUTCOME MEASURES: The primary outcome was symptom burden (Memorial Symptom Assessment Scale; MSAS). Secondary outcomes were health related quality of life (Functional Assessment of Cancer Therapy-General; FACT-G), Supportive Care Needs Survey Short-Form (SCNS-SF34), State-Trait Anxiety Inventory-Revised (STAI-R), Communication and Attitudinal Self-Efficacy scale for cancer (CASE-Cancer), and work limitations questionnaire (WLQ). RESULTS: For the intervention group, symptom burden remained at pre-chemotherapy treatment levels, whereas controls reported an increase from cycle 1 onwards (least squares absolute mean difference -0.15, 95% confidence interval -0.19 to -0.12; P<0.001; Cohen's D effect size=0.5). Analysis of MSAS sub-domains indicated significant reductions in favour of ASyMS for global distress index (-0.21, -0.27 to -0.16; P<0.001), psychological symptoms (-0.16, -0.23 to -0.10; P<0.001), and physical symptoms (-0.21, -0.26 to -0.17; P<0.001). FACT-G scores were higher in the intervention group across all cycles (mean difference 4.06, 95% confidence interval 2.65 to 5.46; P<0.001), whereas mean scores for STAI-R trait (-1.15, -1.90 to -0.41; P=0.003) and STAI-R state anxiety (-1.13, -2.06 to -0.20; P=0.02) were lower. CASE-Cancer scores were higher in the intervention group (mean difference 0.81, 0.19 to 1.43; P=0.01), and most SCNS-SF34 domains were lower, including sexuality needs (-1.56, -3.11 to -0.01; P<0.05), patient care and support needs (-1.74, -3.31 to -0.16; P=0.03), and physical and daily living needs (-2.8, -5.0 to -0.6; P=0.01). Other SCNS-SF34 domains and WLQ were not significantly different. Safety of ASyMS was satisfactory. Neutropenic events were higher in the intervention group. CONCLUSIONS: Significant reduction in symptom burden supports the use of ASyMS for remote symptom monitoring in cancer care. A "medium" Cohen's effect size of 0.5 showed a sizable, positive clinical effect of ASyMS on patients' symptom experiences. Remote monitoring systems will be vital for future services, particularly with blended models of care delivery arising from the covid-19 pandemic. TRIAL REGISTRATION: Clinicaltrials.gov NCT02356081.

Chronic disease management in heart failure: focus on telemedicine and remote monitoring.

In the context of the COVID-19 pandemic, many barriers to telemedicine disappeared. Virtual visits and telemonitoring strategies became routine. Evidence is accumulating regarding the safety and efficacy of virtual visits to replace in-person visits. A structured approach to virtual encounters is recommended. Telemonitoring includes patient reported remote vital sign monitoring, information from wearable devices, cardiac implantable electronic devices and invasive remote hemodynamic monitoring. The intensity of the monitoring should match the risk profile of the patient. Attention to cultural and educational barriers is important to prevent disparities in telehealth implementation.

The Performance of Digital Monitoring Devices for Oxygen Saturation and Respiratory Rate in COPD: A Systematic Review.

Healthcare access and delivery for individuals with chronic obstructive pulmonary disease (COPD) who live in remote areas or who are susceptible to contracting communicable diseases, such as COVID-19, may be a challenge. Telehealth and remote monitoring devices can be used to overcome this issue. However, the accuracy of these devices must be ensured before forming healthcare decisions based on their outcomes. Therefore, a systematic review was performed to synthesize the evidence on the reliability, validity and responsiveness of digital devices used for tracking oxygen saturation (SpO2) and/or respiratory rate (RR) in individuals with COPD, in remote settings. Three electronic databases were searched: MEDLINE (1996 to October 8, 2020), EMBASE (1996 to October 8, 2020) and CINAHL (1998 to October 8, 2020). Studies were included if they aimed to evaluate one or more measurement properties of a digital device measuring SpO2 or RR in individuals with COPD. Six-hundred and twenty-five articles were identified and after screening, 7 studies matched the inclusion criteria; covering 11 devices measuring SpO2 and/or RR. Studies reported on the reliability (n = 1), convergent validity (n = 1), concurrent validity (n = 2) and predictive validity (n = 2) of SpO2 devices and on the convergent validity (n = 1), concurrent validity (n = 1) and predictive validity (n = 1) of RR devices. SpO2 and RR devices were valid when compared against other respiration monitoring devices but were not precise in predicting exacerbation events. More well-designed measurement studies are needed to make firm conclusions about the accuracy of such devices.Supplemental data for this article is available online at https://doi.org/10.1080/15412555.2021.1945021 .

Changes in sleep phase and body weight of mobile health App users during COVID-19 mild lockdown in Japan.

OBJECTIVE AND METHOD: The stay-at-home order during the COVID-19 pandemic has restricted individuals' social behaviors, and therefore, effected their lifestyle including sleep, diet, and physical activity. Using the cross-sectional study design with a large sample size (N = 30,275) from the mobile health App users in Japan, we show age-dependent lifestyle changes during a nonpunitive "mild lockdown" (from April to May 2020). RESULTS: Sleep onset and offset were delayed on work-days but not on free-days with increased sleep duration and decreased social jetlag, and the changes were more evident in the younger population. Although average weight change was close to none because of the users' characteristic (95% of App users try to lose weight), we investigated an association between lifestyle change and body-weight change. Participants who reported advanced sleep phase during mild lockdown described a weight decrease. In contrast, the delayed sleep phase reported a weight gain. The results were significant after adjustment of confounding factors including physical activity and meal changes. CONCLUSIONS: Although there is cumulative evidence showing a relationship between late chronotype and obesity, it is still unclear about the potential benefit of the chronotype management to control body weight. Thus, to the best of our knowledge, this is the first study investigating the association between chronotype and weight changes by leveraging a large cohort.

Remote Reminiscence Using Immersive Virtual Reality May Be Efficacious for Reducing Anxiety in Patients with Mild Cognitive Impairment Even in COVID-19 Pandemic: A Case Report.

To prevent cognitive decline, non-pharmacological therapies such as reminiscence for mild cognitive impairment (MCI) are required, however, the use of nursing homes was limited due to coronavirus disease 2019 (COVID-19). Therefore, the demand for remote-care is increasing. We hypothesized that immersive virtual reality (iVR) could be used more effectively than conventional reminiscence for anxiety. We first examined the effectiveness and safety of reminiscence using iVR (iVR reminiscence session) in patients with MCI. After COVID-19 imposed restriction on visiting nursing homes, we conducted online iVR reminiscence session (remote iVR reminiscence session) and compared its effectiveness with that of interpersonal iVR reminiscence session (face-to-face iVR reminiscence session). The results of two elderly with MCI suggested that iVR reminiscence could reduce anxiety and the burden of care without serious side effects. The effects of remote iVR reminiscence might be almost as effective as those of face-to-face one.

Neighborhood Broadband and Use of Telehealth Among Older Adults: Cross-sectional Study of National Survey Data Linked With Census Data.

BACKGROUND: The COVID-19 pandemic has amplified the role of telehealth in health care delivery. Regional variation in internet access and telehealth use are well-documented, but the effect of neighborhood factors, including the pervasiveness of broadband internet, on older adults' telehealth usage in the context of internet access is not known. OBJECTIVE: This study aimed to investigate how individual and neighborhood characteristics, including the pervasiveness of neighborhood broadband internet subscription, are associated with engagement in telehealth among older adults with internet access. METHODS: In this cross-sectional study, we included 5117 community-living older adults aged ≥65 years, who participated in the 2017 National Health and Aging Trends Study with census tract-level data for participants' places of residence from the American Community Survey. RESULTS: Of an estimated 35.3 million community-living older adults, 21.1 million (59.7%) were internet users, and of this group, more than one-third (35.8%) engaged in telehealth. In a multivariable regression model adjusted for individual- and neighborhood-level factors, age, education, income, and the pervasiveness of neighborhood broadband internet subscription were associated with engagement in telehealth, while race, health, county metropolitan status, and neighborhood social deprivation were not. Among internet users, living in a neighborhood at the lowest (versus highest) tertile of broadband internet subscription was associated with being 40% less likely to engage in telehealth (adjusted odds ratio 0.61, 95% CI 0.42-0.87), all else equal. CONCLUSIONS: Neighborhood broadband internet stands out as a mutable characteristic that is consequential to engagement in telehealth.

Lockdown, slow down: impact of the COVID-19 pandemic on physical activity-an observational study.

AIMS: In response to the COVID-19 pandemic, the UK was placed under strict lockdown measures on 23 March 2020. The aim of this study was to quantify the effects on physical activity (PA) levels using data from the prospective Triage-HF Plus Evaluation study. METHODS: This study represents a cohort of adult patients with implanted cardiac devices capable of measuring activity by embedded accelerometery via a remote monitoring platform. Activity data were available for the 4 weeks pre-implementation and post implementation of 'stay at home' lockdown measures in the form of 'minutes active per day' (min/day). RESULTS: Data were analysed for 311 patients (77.2% men, mean age 68.8, frailty 55.9%. 92.2% established heart failure (HF) diagnosis, of these 51.2% New York Heart Association II), with comorbidities representative of a real-world cohort.Post-lockdown, a significant reduction in median PA equating to 20.8 active min/day was seen. The reduction was uniform with a slightly more pronounced drop in PA for women, but no statistically significant difference with respect to age, body mass index, frailty or device type. Activity dropped in the immediate 2-week period post-lockdown, but steadily returned thereafter. Median activity week 4 weeks post-lockdown remained significantly lower than 4 weeks pre-lockdown (p≤0.001). CONCLUSIONS: In a population of predominantly HF patients with cardiac devices, activity reduced by approximately 20 min active per day in the immediate aftermath of strict COVID-19 lockdown measures. TRIAL REGISTRATION NUMBER: NCT04177199.

Digital Therapeutics in Parkinson's Disease: Practical Applications and Future Potential.

Digital therapeutics, treatments delivered remotely and enabled by modern technology, facilitate the provision of personalized, evidence-based, interdisciplinary interventions to manage the complexities associated with Parkinson's disease. In the context of the COVID-19 pandemic, the need for digital therapeutics has arguably never been greater. However, despite new advances in technology and a heightened interest due to the pandemic, digital therapeutics remain underdeveloped and underutilized. In this paper, we briefly review practical applications and emerging advances in digital therapeutic platforms that target motor and non-motor signs and healthy lifestyle behaviors such as regular exercise, a healthful diet and optimal sleep hygiene habits. Future applications which could transform personalized self-management and patient care are presented. Opportunities, drawbacks and barriers to access are discussed.

Telehealth Demand Trends During the COVID-19 Pandemic in the Top 50 Most Affected Countries: Infodemiological Evaluation.

BACKGROUND: The COVID-19 pandemic has led to urgent calls for the adoption of telehealth solutions. However, public interest and demand for telehealth during the pandemic remain unknown. OBJECTIVE: We used an infodemiological approach to estimate the worldwide demand for telehealth services during COVID-19, focusing on the 50 most affected countries and comparing the demand for such services with the level of information and communications technology (ICT) infrastructure available. METHODS: We used Google Trends, the Baidu Index (China), and Yandex Keyword Statistics (Russia) to extract data on worldwide and individual countries' telehealth-related internet searches from January 1 to July 7, 2020, presented as relative search volumes (RSV; range 0-100). Daily COVID-19 cases and deaths were retrieved from the World Health Organization. Individual countries' ICT infrastructure profiles were retrieved from the World Economic Forum Report. RESULTS: Across the 50 countries, the mean RSV was 18.5 (SD 23.2), and the mean ICT index was 62.1 (SD 15.0). An overall spike in worldwide telehealth-related RSVs was observed from March 11, 2020 (RSV peaked to 76.0), which then tailed off in June-July 2020 (mean RSV for the period was 25.8), but remained higher than pre-March RSVs (mean 7.29). By country, 42 (84%) manifested increased RSVs over the evaluation period, with the highest observed in Canada (RSV=100) and the United States (RSV=96). When evaluating associations between RSV and the ICT index, both the United States and Canada demonstrated high RSVs and ICT scores (≥70.3). In contrast, European countries had relatively lower RSVs (range 3.4-19.5) despite high ICT index scores (mean 70.3). Several Latin American (Brazil, Chile, Colombia) and South Asian (India, Bangladesh, Pakistan) countries demonstrated relatively higher RSVs (range 13.8-73.3) but low ICT index scores (mean 44.6), indicating that the telehealth demand outstrips the current ICT infrastructure. CONCLUSIONS: There is generally increased interest and demand for telehealth services across the 50 countries most affected by COVID-19, highlighting the need to scale up telehealth capabilities, during and beyond the pandemic.