Background: Heart failure (HF) is a complex syndrome associated with high morbidity and mortality and increased healthcare utilisation. Patient education is key to improving health outcomes, achieved by promoting self-management to optimise medical management. Newer digital tools like text messaging and smartphone applications provide novel patient education approaches.
Objective: To partner with clinicians and people with lived experience of HF to identify the priority educational topic areas to inform the development and delivery of a bank of electronic-message driven tips ('e-TIPS') to support HF self-management.
Methods: We conducted three focus groups with cardiovascular clinicians, people with lived experience of HF and their caregivers, which consisted of two stages: Stage 1 - an exploratory qualitative study to identify the unmet educational needs of people living with HF (previously reported) and Stage 2 - a co-design feedback session to identify educational topic areas and inform the delivery of e-TIPS. This paper reports the findings of the co-design feedback session.
Results: We identified five key considerations in delivering e-TIPS and five relevant HF educational topics for their content. Key considerations in e-TIP delivery included: (i) Timing of the e-TIPS; (ii) Clear and concise e-TIPS; (iii) Embedding a feedback mechanism; (iv) Distinguishing actionable and non-actionable e-TIPS; and (v) Frequency of e-TIP delivery. Relevant educational topic areas included: (i) cardiovascular risk reduction; (ii) Self-management; (iii) Food and nutrition; (iv) Sleep hygiene; and (v) Mental health.
Conclusions: The findings from this co-design case study have provided a foundation for developing a bank of e-TIPS. These will now be evaluated for usability in the BANDAIDS e-TIPS, a single group, quasi-experimental study of a 24-week e-TIP program (personalised educational messages) delivered via Short Message Service (ACTRN12623000644662).
Clinicaltrial:
The majority of Black women with hypertension in the United States have smartphones or tablets and use social media, and many use wearable activity trackers and health or wellness apps, digital tools that can be used to support lifestyle changes and medication adherence.
Background: For a decade, despite results from many studies, telemedicine systems have suffered from a lack of recommendations for chronic heart failure (CHF) care because of variable study results. Another limitation is the hospital-based architecture of most telemedicine systems. Some systems use an algorithm based on daily weight, transcutaneous oxygen measurement, and heart rate to detect and treat acute heart failure (AHF) in patients with CHF as early on as possible.
Objective: The aim of this study is to determine the efficacy of a telemonitoring system in detecting clinical destabilization in real-life settings (out-of-hospital management) without generating too many false positive alerts.
Methods: All patients self-monitoring at home using the system after a congestive AHF event treated at a cardiology clinic in France between March 2020 and March 2021 with at least 75% compliance on daily measurements were included retrospectively. New-onset AHF was defined by the presence of at least 1 of the following criteria: transcutaneous oxygen saturation loss, defined as a transcutaneous oxygen measurement under 90%; rise of cardiac frequency above 110 beats per minute; weight gain of at least 2 kg; and symptoms of congestive AHF, described over the phone. An AHF alert was generated when the criteria reached our definition of new-onset acute congestive heart failure (HF).
Results: A total of 111 consecutive patients (n=70 men) with a median age of 76.60 (IQR 69.5-83.4) years receiving the telemonitoring system were included. Thirty-nine patients (35.1%) reached the HF warning level, and 28 patients (25%) had confirmed HF destabilization during follow-up. No patient had AHF without being detected by the telemonitoring system. Among incorrect AHF alerts (n=11), 5 patients (45%) had taken inaccurate measurements, 3 patients (27%) had supraventricular arrhythmia, 1 patient (9%) had a pulmonary bacterial infection, and 1 patient (9%) contracted COVID-19. A weight gain of at least 2 kg within 4 days was significantly associated with a correct AHF alert (P=.004), and a heart rate of more than 110 beats per minute was more significantly associated with an incorrect AHF alert (P=.007).
Conclusions: This single-center study highlighted the efficacy of the telemedicine system in detecting and quickly treating cardiac instability complicating the course of CHF by detecting new-onset AHF as well as supraventricular arrhythmia, thus helping cardiologists provide better follow-up to ambulatory patients.
Background: Heart failure (HF) is a burdensome condition and a leading cause of 30-day hospital readmissions in the United States. Clinical and social factors are key drivers of hospitalization. These 2 strategies, digital platforms and home-based social needs care, have shown preliminary effectiveness in improving adherence to clinical care plans and reducing acute care use in HF. Few studies, if any, have tested combining these 2 strategies in a single intervention.
Objective: This study aims to perform a pilot randomized controlled trial assessing the acceptability, feasibility, and preliminary effectiveness of a 30-day digitally-enabled community health worker (CHW) intervention in HF.
Methods: Adults hospitalized with a diagnosis of HF at an academic hospital were randomly assigned to receive digitally-enabled CHW care (intervention; digital platform +CHW) or CHW-enhanced usual care (control; CHW only) for 30 days after hospital discharge. Primary outcomes were feasibility (use of the platform) and acceptability (willingness to use the platform in the future). Secondary outcomes assessed preliminary effectiveness (30-day readmissions, emergency department visits, and missed clinic appointments).
Results: A total of 56 participants were randomized (control: n=31; intervention: n=25) and 47 participants (control: n=28; intervention: n=19) completed all trial activities. Intervention participants who completed trial activities wore the digital sensor on 78% of study days with mean use of 11.4 (SD 4.6) hours/day, completed symptom questionnaires on 75% of study days, used the blood pressure monitor 1.1 (SD 0.19) times/day, and used the digital weight scale 1 (SD 0.13) time/day. Of intervention participants, 100% responded very or somewhat true to the statement "If I have access to the [platform] moving forward, I will use it." Some (n=9, 47%) intervention participants indicated they required support to use the digital platform. A total of 19 (100%) intervention participants and 25 (89%) control participants had ≥5 CHW interactions during the 30-day study period. All intervention (n=19, 100%) and control (n=26, 93%) participants who completed trial activities indicated their CHW interactions were "very satisfying." In the full sample (N=56), fewer participants in the intervention group were readmitted 30 days after hospital discharge compared to the control group (n=3, 12% vs n=8, 26%; P=.12). Both arms had similar rates of missed clinic appointments and emergency department visits.
Conclusions: This pilot trial of a digitally-enabled CHW intervention for HF demonstrated feasibility, acceptability, and a clinically relevant reduction in 30-day readmissions among participants who received the intervention. Additional investigation is needed in a larger trial to determine the effect of this intervention on HF home management and clinical
Background: The key to reducing the immense morbidity and mortality burdens of cardiovascular diseases is to help people keep their blood pressure (BP) at safe levels. This requires that more people with hypertension be identified, diagnosed, and given tools to lower their BP. BP monitors are critical to hypertension diagnosis and management. However, there are characteristics of conventional BP monitors (oscillometric cuff sphygmomanometers) that hinder rapid and effective hypertension diagnosis and management. Calibration-free, software-only BP monitors that operate on ubiquitous mobile devices can enable on-demand BP monitoring, overcoming the hardware barriers of conventional BP monitors.
Objective: This study aims to investigate the accuracy of a contactless BP monitor software app for classifying the full range of clinically relevant BPs as hypertensive or nonhypertensive and to evaluate its accuracy for measuring the pulse rate (PR) and BP of people with BPs relevant to stage-1 hypertension.
Methods: The software app, known commercially as Lifelight, was investigated following the data collection and data analysis methodology outlined in International Organization for Standardization (ISO) 81060-2:2018/AMD 1:2020 "Non-invasive Sphygmomanometers-Part 2: Clinical investigation of automated measurement type." This validation study was conducted by the independent laboratory Element Materials Technology Boulder (formerly Clinimark). The study generated data from 85 people aged 18-85 years with a wide-ranging distribution of BPs specified in ISO 81060-2:2018/AMD 1:2020. At least 20% were required to have Fitzpatrick scale skin tones of 5 or 6 (ie, dark skin tones). The accuracy of the app's BP measurements was assessed by comparing its BP measurements with measurements made by dual-observer manual auscultation using the same-arm sequential method specified in ISO 81060-2:2018/AMD 1:2020. The accuracy of the app's PR measurements was assessed by comparing its measurements with concurrent electroencephalography-derived heart rate values.
Results: The app measured PR with an accuracy root-mean-square of 1.3 beats per minute and mean absolute error of 1.1 (SD 0.8) beats per minute. The sensitivity and specificity with which it determined that BPs exceeded the in-clinic systolic threshold for hypertension diagnosis were 70.1% and 71.7%, respectively. These rates are consistent with those reported for conventional BP monitors in a literature review by The National Institute for Health and Care Excellence. The app's mean error for measuring BP in the range of normotension and stage-1 hypertension (ie, 65/85, 76% of participants) was 6.5 (SD 12.9) mm Hg for systolic BP and 0.4 (SD 10.6) mm Hg for diastolic BP. Mean absolute error was 11.3 (SD 10.0) mm Hg and 8.6 (SD 6.8) mm Hg, respectively.
Conclusions: A calibration-free, software-only medi
Background: Although telemedicine has been proven to have significant potential for improving care for patients with cardiac problems, there remains a substantial risk of introducing disparities linked to the use of digital technology, especially for older or socially vulnerable subgroups.
Objective: We investigated factors influencing adherence to a telemedicine-delivered health education intervention in patients with ischemia, emphasizing demographic and socioeconomic considerations.
Methods: We conducted a descriptive, observational, prospective cohort study in consecutive patients referred to our cardiology center for acute coronary syndrome, from February 2022 to January 2023. Patients were invited to join a web-based health educational meeting (WHEM) after hospital discharge, as part of a secondary prevention program. The WHEM sessions were scheduled monthly and used a teleconference software program for remote synchronous videoconferencing, accessible through a standard computer, tablet, or smartphone based on patient preference or availability.
Results: Out of the 252 patients (median age 70, IQR 61.0-77.3 years; n=189, 75% male), 98 (38.8%) declined the invitation to participate in the WHEM. The reasons for nonacceptance were mainly challenges in handling digital technology (70/98, 71.4%), followed by a lack of confidence in telemedicine as an integrative tool for managing their medical condition (45/98, 45.9%), and a lack of internet-connected devices (43/98, 43.8%). Out of the 154 patients who agreed to participate in the WHEM, 40 (25.9%) were unable to attend. Univariable logistic regression analysis showed that the presence of a caregiver with digital proficiency and a higher education level was associated with an increased likelihood of attendance to the WHEM, while the converse was true for increasing age and female sex. After multivariable adjustment, higher education level (odds ratio [OR] 2.26, 95% CI 1.53-3.32; P<.001) and caregiver with digital proficiency (OR 12.83, 95% CI 5.93-27.75; P<.001) remained independently associated with the outcome. The model discrimination was good even when corrected for optimism (optimism-corrected C-index=0.812), as was the agreement between observed and predicted probability of participation (optimism-corrected calibration intercept=0.010 and slope=0.948).
Conclusions: This study identifies a notable lack of suitability for a specific cohort of patients with ischemia to participate in our telemedicine intervention, emphasizing the risk of digital marginalization for a significant portion of the population. Addressing low digital literacy rates among patients or their informal caregivers and overcoming cultural bias against remote care were identified as critical issues in our study findings to facilitate the broader adoption of telemedicine as an inclusive tool in health care.
Background: Patients with heart failure (HF) are the most commonly readmitted group of adult patients in Germany. Most patients with HF are readmitted for noncardiovascular reasons. Understanding the relevance of HF management outside the hospital setting is critical to understanding HF and factors that lead to readmission. Application of machine learning (ML) on data from statutory health insurance (SHI) allows the evaluation of large longitudinal data sets representative of the general population to support clinical decision-making.
Objective: This study aims to evaluate the ability of ML methods to predict 1-year all-cause and HF-specific readmission after initial HF-related admission of patients with HF in outpatient SHI data and identify important predictors.
Methods: We identified individuals with HF using outpatient data from 2012 to 2018 from the AOK Baden-Württemberg SHI in Germany. We then trained and applied regression and ML algorithms to predict the first all-cause and HF-specific readmission in the year after the first admission for HF. We fitted a random forest, an elastic net, a stepwise regression, and a logistic regression to predict readmission by using diagnosis codes, drug exposures, demographics (age, sex, nationality, and type of coverage within SHI), degree of rurality for residence, and participation in disease management programs for common chronic conditions (diabetes mellitus type 1 and 2, breast cancer, chronic obstructive pulmonary disease, and coronary heart disease). We then evaluated the predictors of HF readmission according to their importance and direction to predict readmission.
Results: Our final data set consisted of 97,529 individuals with HF, and 78,044 (80%) were readmitted within the observation period. Of the tested modeling approaches, the random forest approach best predicted 1-year all-cause and HF-specific readmission with a C-statistic of 0.68 and 0.69, respectively. Important predictors for 1-year all-cause readmission included prescription of pantoprazole, chronic obstructive pulmonary disease, atherosclerosis, sex, rurality, and participation in disease management programs for type 2 diabetes mellitus and coronary heart disease. Relevant features for HF-specific readmission included a large number of canonical HF comorbidities.
Conclusions: While many of the predictors we identified were known to be relevant comorbidities for HF, we also uncovered several novel associations. Disease management programs have widely been shown to be effective at managing chronic disease; however, our results indicate that in the short term they may be useful for targeting patients with HF with comorbidity at increased risk of readmission. Our results also show that living in a more rural location increases the risk of readmission. Overall, factors beyond comorbid disease were relevant for risk of HF read
Background: Heart failure (HF) contributes greatly to morbidity, mortality, and health care costs worldwide. Hospital readmission rates are tracked closely and determine federal reimbursement dollars. No current modality or technology allows for accurate measurement of relevant HF parameters in ambulatory, rural, or underserved settings. This limits the use of telehealth to diagnose or monitor HF in ambulatory patients.
Objective: This study describes a novel HF diagnostic technology using audio recordings from a standard mobile phone.
Methods: This prospective study of acoustic microphone recordings enrolled convenience samples of patients from 2 different clinical sites in 2 separate areas of the United States. Recordings were obtained at the aortic (second intercostal) site with the patient sitting upright. The team used recordings to create predictive algorithms using physics-based (not neural networks) models. The analysis matched mobile phone acoustic data to ejection fraction (EF) and stroke volume (SV) as evaluated by echocardiograms. Using the physics-based approach to determine features eliminates the need for neural networks and overfitting strategies entirely, potentially offering advantages in data efficiency, model stability, regulatory visibility, and physical insightfulness.
Results: Recordings were obtained from 113 participants. No recordings were excluded due to background noise or for any other reason. Participants had diverse racial backgrounds and body surface areas. Reliable echocardiogram data were available for EF from 113 patients and for SV from 65 patients. The mean age of the EF cohort was 66.3 (SD 13.3) years, with female patients comprising 38.3% (43/113) of the group. Using an EF cutoff of ≤40% versus >40%, the model (using 4 features) had an area under the receiver operating curve (AUROC) of 0.955, sensitivity of 0.952, specificity of 0.958, and accuracy of 0.956. The mean age of the SV cohort was 65.5 (SD 12.7) years, with female patients comprising 34% (38/65) of the group. Using a clinically relevant SV cutoff of <50 mL versus >50 mL, the model (using 3 features) had an AUROC of 0.922, sensitivity of 1.000, specificity of 0.844, and accuracy of 0.923. Acoustics frequencies associated with SV were observed to be higher than those associated with EF and, therefore, were less likely to pass through the tissue without distortion.
Conclusions: This work describes the use of mobile phone auscultation recordings obtained with unaltered cellular microphones. The analysis reproduced the estimates of EF and SV with impressive accuracy. This technology will be further developed into a mobile app that could bring screening and monitoring of HF to several clinical settings, such as home or telehealth, rural, remote, and underserved areas across the globe. This would bring high-quality diagnostic methods to patient
Background: Behavior change support systems (BCSSs) have the potential to help people maintain healthy lifestyles and aid in the self-management of coronary heart disease (CHD). The Persuasive Systems Design (PSD) model is a framework for designing and evaluating systems designed to support lifestyle modifications and health behavior change using information and communication technology. However, evidence for the underlying design principles behind BCSSs for CHD has not been extensively reported in the literature.
Objective: This scoping review aims to identify existing health BCSSs for CHD, report the characteristics of these systems, and describe the persuasion context and persuasive design principles of these systems based on the PSD framework.
Methods: Using the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) guidelines, 3 digital databases (Scopus, Web of Science, and MEDLINE) were searched between 2010 to 2022. The major inclusion criteria for studies were in accordance with the PICO (Population, Intervention, Comparison, and Outcome) approach.
Results: Searches conducted in the databases identified 1195 papers, among which 30 were identified as eligible for the review. The most interesting characteristics of the BCSSs were the predominant use of primary task support principles, followed by dialogue support and credibility support and the sparing use of social support principles. Theories of behavior change such as the Social Cognitive Theory and Self-Efficacy Theory were used often to underpin these systems. However, significant trends in the use of persuasive system features on par with behavior change theories could not be established from the reviewed studies. This points to the fact that there is still no theoretical consensus on how best to design interventions to promote behavior change in patients with CHD.
Conclusions: Our results highlight key software features for designing BCSSs for the prevention and management of CHD. We encourage designers of behavior change interventions to evaluate the techniques that contributed to the success of the intervention. Future research should focus on evaluating the effectiveness of the interventions, persuasive design principles, and behavior change theories using research methodologies such as meta-analysis.
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