Dataset Information

Digital health care solution for proactive heart failure management with the Cordella Heart Failure System: results of the SIRONA first-in-human study.

ABSTRACT: Aims: Incorporation of remote monitoring of pulmonary artery pressure and vital signs has been demonstrated to reduce heart failure (HF) hospitalization and all-cause mortality in selected symptomatic HF patients. The aim of this study is to investigate the safety and accuracy of the new Cordella^TM Pulmonary Artery Pressure Sensor (Endotronix, Inc., Chicago, IL, USA) and the usability of the comprehensive Cordella^TM Heart Failure System (CHFS).

Methods and results: Multicentre, open-label, first-in-human, feasibility study to evaluate the CHFS and the safety and accuracy of the Cordella™ Pulmonary Artery Pressure Sensor in 15 patients with New York Heart Association class III HF. All patients were successfully implanted with the Cordella Pulmonary Artery Pressure Sensor, without sensor failure. No device system-related complications, defined as invasive treatment, device explant or death, occurred. The primary efficacy endpoint of a mean pulmonary artery pressure at 90?days was met in all but one patients with a cohort difference of 2.7?mmHg (Cordella Sensor 22.5?±?11.8?mmHg, Swan-Ganz catheter 25.2?±?8.5?mmHg). One patient did not go through the 90-day right heart catheterization for safety reasons. Patient adherence to daily measurement, transmission of vital signs and pulmonary artery pressure sensor readings were recorded 99% of the time.

Conclusion: The initial experience of the CHFS incorporating comprehensive vital signs and pulmonary artery pressure monitoring enables safe and accurate monitoring of HF status.

SUBMITTER: Mullens W

PROVIDER: S-EPMC7687200 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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Digital health care solution for proactive heart failure management with the Cordella Heart Failure System: results of the SIRONA first-in-human study.

Mullens Wilfried W Sharif Faisal F Dupont Matthias M Rothman Alexander M K AMK Wijns William W

European journal of heart failure 20200531 10

<h4>Aims</h4>Incorporation of remote monitoring of pulmonary artery pressure and vital signs has been demonstrated to reduce heart failure (HF) hospitalization and all-cause mortality in selected symptomatic HF patients. The aim of this study is to investigate the safety and accuracy of the new Cordella<sup>TM</sup> Pulmonary Artery Pressure Sensor (Endotronix, Inc., Chicago, IL, USA) and the usability of the comprehensive Cordella<sup>TM</sup> Heart Failure System (CHFS).<h4>Methods and results ...[more]

PMID: 32476191

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Project description:BackgroundThe management of heart failure (HF) is challenging because of the complexities in recommended therapies. Integrated disease management (IDM) is an effective model, promoting guideline-directed care, but the impact of IDM in the community setting requires further evaluation.MethodsA retrospective evaluation of community-based IDM. Patient characteristics were described, and outcomes using a pre- and post-intervention design were HF-related health-service use, quality of life, and concordance with guideline-directed medical therapy (GDMT).Results715 patients were treated in the program (2016 to 2023), 219 in a community specialist-care clinic, and 496 in 25 primary-care clinics. The overall cohort was predominantly male (60%), with a mean age of 73.5 years (± 10.7), and 60% with HF with reduced ejection fraction. In patients with ≥ 6 months of follow-up (n = 267), pre vs post annualized rates of HF-related acute health-service use decreased from 36.3 to 8.5 hospitalizations per 100 patients per year, P < 0.0001, from 31.8 to 13.1 emergency department visits per 100 patients per year, P < 0.0001, and from 152.8 to 110.0 urgent physician visits per 100 patients per year, P = 0.0001. The level of concordance with GDMT improved; the number of patients receiving triple therapy and quadruple therapy increased by 10.1% (95% confidence interval [CI], 2.4%,17.8%) and 19.6% (95% CI, 12.0%, 27.3%), respectively. Within these groups, optimal dosing was achieved in 42.5% (95% CI, 32.0%, 53.6%) and 35.0% (95% CI, 23.1%, 48.4%), respectively. In patients with at least one follow-up visit (n = 286), > 50% experienced a clinically relevant improvement in their quality of life.ConclusionsA community-based IDM program for HF, may reduce HF-related acute health-service use, improve quality of life and level of concordance with GDMT. These encouraging preliminary outcomes from a real-world program evaluation require confirmation in a randomized controlled trial.

Project description:BackgroundHeart failure (HF) affects over 26 million people worldwide. Multidisciplinary management strategies that include symptom monitoring and patient self-care support reduce HF hospitalization and mortality rates. Ideally, HF follow-up and self-care support includes lifestyle-change recommendations and remote monitoring of weight and HF symptoms. Providing these via a digital solution may be ideal for improving HF disease outcomes and reducing the burden on providers and healthcare systems. This study's main objective was to assess the feasibility of a digital solution including remote monitoring, lifestyle-change, and self-care support for HF outpatients in Iceland.MethodsTwenty HF patients (mean age 57.5 years, 80% males) participated in an 8-week study. They were provided with a digital solution (SK-141), including lifestyle-change and disease self-care support, a remote symptom monitoring system, and a secure messaging platform between healthcare providers and patients. This feasibility study aimed to assess patient acceptability of this new intervention, retention rate, and to evaluate trends in clinical outcomes. To assess the acceptability of SK-141, participants completed a questionnaire about their experience after the 8-week study. Participants performed daily assigned activities (missions), including self-reporting symptoms. Clinical outcomes were assessed with the Hospital Anxiety and Depression Scale and the Kansas City Cardiomyopathy Questionnaire at the study's beginning and end with an online survey.ResultsOf the 24 patients invited, 20 were elected to participate. The retention rate of participants throughout the 8-week period was high (80%). At the end of the 8 weeks, thirteen participants completed a questionnaire about their experience and acceptability of the SK-141. They rated their experience positively including on questions whether they would recommend the solution to others (6.8 on a scale of 1-7), whether the solution had improved their life and well-being (5.7 on a scale of 1-7), and whether it was user friendly (5.5 on a scale of 1-7). Many of the clinical parameters studied exhibited a promising trend towards improvement over the 8-week period.ConclusionThe digital solution, SK-141, was very acceptable to patients and also showed promising clinical results in this small feasibility study. These results encourage us to conduct a longer, more extensive, adequately powered, randomized-controlled study to assess whether this digital solution can improve the quality of life and clinical outcomes among HF patients.

Project description:Aims and objectivesTo evaluate acceptability, efficiency, and quality of a new digital care management system in a residential aged care home (RACH).BackgroundImproving care quality and efficiency in RACH, while simultaneously upgrading data management, is a priority for communities and governments.DesignParticipatory action research with mixed methods data collection was employed to evaluate a digital care management system implemented at a 169-bed RACH. This paper reports qualitative findings of the 2-year evaluation.MethodsQualitative data were collected using focus groups with residents, visitors, nurses, managers, care workers, and consultants; resident/visitor and staff hallway interviews and responses to open-ended questions in online staff surveys. Data were analysed thematically under the four predetermined study objectives. Reporting adhered to COREQ guidelines.Results325 data captures from 88 participants, over seven data sources were coded. Findings indicate that the system was acceptable to both residents and staff due to perceptions of time-saving and improved quality of care. Increased efficiency was perceived through timeliness as well as reduced time spent retrieving and documenting information. Quality of care was improved through care scheduling individualised to resident needs, with reminders to avoid missed care. Relatives were reassured and activities were scheduled to loved one's preferences. The co-design implementation process was successful through commitment to quality from leadership teams and prioritising the focus on the holistic needs of the residents.ConclusionA strong emphasis on co-design with care staff in developing and implementing the digital care system contributed to a system that supported nursing and care work, facilitated reporting and documentation, and improved resident care and well-being including identification of missed care.Relevance to clinical practiceNurses, carers, administrators, and advocates can support the co-design creation of information systems that suit the workflow of an organisation and keep the focus on individualised models of care provision.

Project description:BackgroundPoor self-management of heart failure (HF) contributes to devastating health consequences. Our innovative sensor-controlled digital game (SCDG) integrates data from sensors to trigger game rewards, progress, and feedback based on the real-time behaviors of individuals with HF.ObjectiveThe aim of this study is to compare daily weight monitoring and physical activity behavior adherence by older adults using an SCDG intervention versus a sensors-only intervention in a feasibility randomized controlled trial.MethodsEnglish-speaking adults with HF aged 55 years or older who owned a smartphone and could walk unassisted were recruited from Texas and Oklahoma from November 2019 to August 2020. Both groups were given activity trackers and smart weighing scales to track behaviors for 12 weeks. The feasibility outcomes of recruitment, retention, intervention engagement, and satisfaction were assessed. In addition to daily weight monitoring and physical activity adherence, the participants' knowledge, functional status, quality of life, self-reported HF behaviors, motivation to engage in behaviors, and HF-related hospitalization were also compared between the groups at baseline and at 6, 12, and 24 weeks.ResultsA total of 38 participants with HF-intervention group (IG; 19/38, 50%) and control group (CG; 19/38, 50%)-were enrolled in the study. Of the 38 participants, 18 (47%) were women, 18 (47%) were aged 65 years or older, 21 (55%) had been hospitalized with HF in the past 6 months, and 29 (76%) were White. Furthermore, of these 38 participants, 31 (82%)-IG (15/19, 79%) and CG (16/19, 84%)-had both weight monitoring and physical activity data at the end of 12 weeks, and 27 (71%)-IG (14/19, 74%) and CG (13/19, 68%)-participated in follow-up assessments at 24 weeks. For the IG participants who installed the SCDG app (15/19, 79%), the number of days each player opened the game app was strongly associated with the number of days the player engaged in weight monitoring (r=0.72; P=.04) and the number of days with physical activity step data (r=0.9; P<.001). The IG participants who completed the satisfaction survey (13/19, 68%) reported that the SCDG was easy to use. Trends of improvement in daily weight monitoring and physical activity in the IG, as well as within-group improvements in HF functional status, quality of life, knowledge, self-efficacy, and HF hospitalization in both groups, were observed in this feasibility trial.ConclusionsPlaying an SCDG on smartphones was feasible and acceptable for older adults with HF for motivating daily weight monitoring and physical activity. A larger efficacy trial of the SCDG intervention will be needed to validate trends of improvement in daily weight monitoring and physical activity behaviors.Trial registrationClinicalTrials.gov NCT03947983; https://clinicaltrials.gov/ct2/show/NCT03947983.

Project description:BackgroundHeart failure (HF) is the leading cause of hospitalization among older adults in the United States. There are substantial racial and geographic disparities in HF outcomes, with patients living in southern US states having a mortality rate 69% higher than the national average. Self-management behaviors, particularly daily weight monitoring and physical activity, are extremely important in improving HF outcomes; however, patients typically have particularly low adherence to these behaviors. With the rise of digital technologies to improve health outcomes and motivate health behaviors, sensor-controlled digital games (SCDGs) have become a promising approach. SCDGs, which leverage sensor-connected technologies, offer the benefits of being portable and scalable and allowing for continuous observation and motivation of health behaviors in their real-world contexts. They are also becoming increasingly popular among older adults and offer an immersive and accessible way to measure self-management behaviors and improve adherence. No SCDGs have been designed for older adults or evaluated to test their outcomes.ObjectiveThis randomized clinical trial aims to assess the efficacy of a SCDG in integrating the behavioral data of participants with HF from weight scale and activity tracker sensors to activate game progress, rewards, and feedback and, ultimately, to improve adherence to important self-management behaviors.MethodsA total of 200 participants with HF, aged ≥45 years, will be recruited and randomized into 2 groups: the SCDG playing group (intervention group) and sensor-only group (control group). Both groups will receive a weight scale, physical activity tracker, and accompanying app, whereas only the intervention group will play the SCDG. This design, thereby, assesses the contributions of the game. All participants will complete a baseline survey as well as posttests at 6 and 12 weeks to assess the immediate effect of the intervention. They will also complete a third posttest at 24 weeks to assess the maintenance of behavioral changes. Efficacy and benefits will be assessed by measuring improvements in HF-related proximal outcomes (self-management behaviors of daily weight monitoring and physical activity) and distal outcomes (HF hospitalization, quality of life, and functional status) between baseline and weeks 6, 12, and 24. The primary outcome measured will be days with weight monitoring, for which this design provides at least 80% power to detect differences between the 2 groups.ResultsRecruitment began in the fall of 2022, and the first patient was enrolled in the study on November 7, 2022. Recruitment of the last participant is expected in quarter 1 of 2025. Publication of complete results and data from this study is expected in 2026.ConclusionsThis project will generate insight and guidance for scalable and easy-to-use digital gaming solutions to motivate persistent adherence to HF self-management behaviors and improve health outcomes among individuals with HF.Trial registrationClinicalTrials.gov NCT05056129; https://clinicaltrials.gov/ct2/show/NCT05056129.International registered report identifier (irrid)DERR1-10.2196/45801.

Dataset Information

Digital health care solution for proactive heart failure management with the Cordella Heart Failure System: results of the SIRONA first-in-human study.

Publications

Digital health care solution for proactive heart failure management with the Cordella Heart Failure System: results of the SIRONA first-in-human study.

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