Dataset Information

Designing meaningful outcome parameters using mobile technology: a new mobile application for telemonitoring of patients with heart failure.

ABSTRACT:

Aims

Health data captured by commercially available smart devices may represent meaningful patient-reported outcome measures (PROMs) in heart failure (HF) patients. The purpose of this study was to test this hypothesis by evaluating the feasibility of a new telemonitoring concept for patients following initial HF hospitalization.

Methods and results

We designed a cardio patient monitoring platform (CPMP) that comprised mobile iOS-based applications for patients' smartphone/smartwatch and the equivalent application on a physicians' tablet. It allowed for safe and continuous data transmission of self-measured physiological parameters, activity data, and patient-reported symptoms. In a prospective feasibility trial with 692 patient days from 10 patients hospitalized for newly diagnosed HF with reduced ejection fraction (mean left ventricular ejection fraction (LVEF) 26.5 ± 9.8%), we examined the CPMP during the first 2 months following discharge (69 ± 15 observation days per patient). The mean daily step count recorded by the mobile devices emerged as a promising new PROM. Its 14 day average increased over the study period (3612 ± 3311 steps/day at study inclusion and 7069 ± 5006 steps/day at end of study; P < 0.0001). It is unique for continuously reflecting real-life activity and correlated significantly with traditional surrogate parameters of cardiac performance including LVEF (r = 0.44; 95% CI 0.07-0.71; P = 0.0232), 6 min walk test (r = 0.67; 95% CI 0.38-0.84; P = 0.0002), and scores in health-related quality of life questionnaires.

Conclusions

We provide the first patient monitoring platform for HF patients that relies on commercially available iOS/watchOS-based devices. Our study suggests it is ready for implementation as a tool for recording meaningful PROMs in future HF trials and telemonitoring.

SUBMITTER: Werhahn SM

PROVIDER: S-EPMC6487706 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

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Publications

Designing meaningful outcome parameters using mobile technology: a new mobile application for telemonitoring of patients with heart failure.

Werhahn Stefanie Maria SM Dathe Henning H Rottmann Thorsten T Franke Thomas T Vahdat Dan D Hasenfuß Gerd G Seidler Tim T

ESC heart failure 20190313 3

<h4>Aims</h4>Health data captured by commercially available smart devices may represent meaningful patient-reported outcome measures (PROMs) in heart failure (HF) patients. The purpose of this study was to test this hypothesis by evaluating the feasibility of a new telemonitoring concept for patients following initial HF hospitalization.<h4>Methods and results</h4>We designed a cardio patient monitoring platform (CPMP) that comprised mobile iOS-based applications for patients' smartphone/smartwa ...[more]

PMID: 30868756

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Project description:Previous trials of telemonitoring for heart failure management have reported inconsistent results, largely due to diverse intervention and study designs. Mobile phones are becoming ubiquitous and economical, but the feasibility and efficacy of a mobile phone-based telemonitoring system have not been determined.The objective of this trial was to investigate the effects of a mobile phone-based telemonitoring system on heart failure management and outcomes.One hundred patients were recruited from a heart function clinic and randomized into telemonitoring and control groups. The telemonitoring group (N = 50) took daily weight and blood pressure readings and weekly single-lead ECGs, and answered daily symptom questions on a mobile phone over 6 months. Readings were automatically transmitted wirelessly to the mobile phone and then to data servers. Instructions were sent to the patients' mobile phones and alerts to a cardiologist's mobile phone as required.Baseline questionnaires were completed and returned by 94 patients, and 84 patients returned post-study questionnaires. About 70% of telemonitoring patients completed at least 80% of their possible daily readings. The change in quality of life from baseline to post-study, as measured with the Minnesota Living with Heart Failure Questionnaire, was significantly greater for the telemonitoring group compared to the control group (P = .05). A between-group analysis also found greater post-study self-care maintenance (measured with the Self-Care of Heart Failure Index) for the telemonitoring group (P = .03). Brain natriuretic peptide (BNP) levels, self-care management, and left ventricular ejection fraction (LVEF) improved significantly for both groups from baseline to post-study, but did not show a between-group difference. However, a subgroup within-group analysis using the data from the 63 patients who had attended the heart function clinic for more than 6 months revealed the telemonitoring group had significant improvements from baseline to post-study in BNP (decreased by 150 pg/mL, P = .02), LVEF (increased by 7.4%, P = .005) and self-care maintenance (increased by 7 points, P = .05) and management (increased by 14 points, P = .03), while the control group did not. No differences were found between the telemonitoring and control groups in terms of hospitalization, mortality, or emergency department visits, but the trial was underpowered to detect differences in these metrics.Our findings provide evidence of improved quality of life through improved self-care and clinical management from a mobile phone-based telemonitoring system. The use of the mobile phone-based system had high adherence and was feasible for patients, including the elderly and those with no experience with mobile phones.ClinicalTrials.gov NCT00778986.

Project description:BackgroundSmall studies suggest that telemonitoring may improve heart-failure outcomes, but its effect in a large trial has not been established.MethodsWe randomly assigned 1653 patients who had recently been hospitalized for heart failure to undergo either telemonitoring (826 patients) or usual care (827 patients). Telemonitoring was accomplished by means of a telephone-based interactive voice-response system that collected daily information about symptoms and weight that was reviewed by the patients' clinicians. The primary end point was readmission for any reason or death from any cause within 180 days after enrollment. Secondary end points included hospitalization for heart failure, number of days in the hospital, and number of hospitalizations.ResultsThe median age of the patients was 61 years; 42.0% were female, and 39.0% were black. The telemonitoring group and the usual-care group did not differ significantly with respect to the primary end point, which occurred in 52.3% and 51.5% of patients, respectively (difference, 0.8 percentage points; 95% confidence interval [CI], -4.0 to 5.6; P=0.75 by the chi-square test). Readmission for any reason occurred in 49.3% of patients in the telemonitoring group and 47.4% of patients in the usual-care group (difference, 1.9 percentage points; 95% CI, -3.0 to 6.7; P=0.45 by the chi-square test). Death occurred in 11.1% of the telemonitoring group and 11.4% of the usual care group (difference, -0.2 percentage points; 95% CI, -3.3 to 2.8; P=0.88 by the chi-square test). There were no significant differences between the two groups with respect to the secondary end points or the time to the primary end point or its components. No adverse events were reported.ConclusionsAmong patients recently hospitalized for heart failure, telemonitoring did not improve outcomes. The results indicate the importance of a thorough, independent evaluation of disease-management strategies before their adoption. (Funded by the National Heart, Lung, and Blood Institute; ClinicalTrials.gov number, NCT00303212.).

Project description:Previous trials of heart failure telemonitoring systems have produced inconsistent findings, largely due to diverse interventions and study designs.The objectives of this study are (1) to provide in-depth insight into the effects of telemonitoring on self-care and clinical management, and (2) to determine the features that enable successful heart failure telemonitoring.Semi-structured interviews were conducted with 22 heart failure patients attending a heart function clinic who had used a mobile phone-based telemonitoring system for 6 months. The telemonitoring system required the patients to take daily weight and blood pressure readings, weekly single-lead ECGs, and to answer daily symptom questions on a mobile phone. Instructions were sent to the patient's mobile phone based on their physiological values. Alerts were also sent to a cardiologist's mobile phone, as required. All clinicians involved in the study were also interviewed post-trial (N = 5). The interviews were recorded, transcribed, and then analyzed using a conventional content analysis approach.The telemonitoring system improved patient self-care by instructing the patients in real-time how to appropriately modify their lifestyle behaviors. Patients felt more aware of their heart failure condition, less anxiety, and more empowered. Many were willing to partially fund the use of the system. The clinicians were able to manage their patients' heart failure conditions more effectively, because they had physiological data reported to them frequently to help in their decision-making (eg, for medication titration) and were alerted at the earliest sign of decompensation. Essential characteristics of the telemonitoring system that contributed to improved heart failure management included immediate self-care and clinical feedback (ie, teachable moments), how the system was easy and quick to use, and how the patients and clinicians perceived tangible benefits from telemonitoring. Some clinical concerns included ongoing costs of the telemonitoring system and increased clinical workload. A few patients did not want to be watched long-term while some were concerned they might become dependent on the system.The success of a telemonitoring system is highly dependent on its features and design. The essential system characteristics identified in this study should be considered when developing telemonitoring solutions.

Project description:BACKGROUND:Seniors with chronic diseases such as heart failure have complex care needs. They are vulnerable to their condition deteriorating and, without timely intervention, may require multiple emergency department visits and/or repeated hospitalizations. Upon discharge, the transition from the emergency department to home can be a vulnerable time for recovering patients with disruptions in the continuity of care. Remote monitoring of heart failure patients using home telemonitoring, coupled with clear communication protocols between health care professionals, can be effective in increasing the safety and quality of care for seniors with heart failure discharged from the emergency department. OBJECTIVE:The aim of the Telehealth for Emergency-Community Continuity of Care Connectivity via Home Telemonitoring (TEC4Home) study is to generate evidence through a programmatic evaluation and a clinical trial to determine how home telemonitoring may improve care and increase patient safety during the transition of care and determine how it is best implemented to support patients with heart failure within this context. METHODS:This 4-year project consists of 3 studies to comprehensively evaluate the outcomes and effectiveness of TEC4Home. Study 1 is a feasibility study with 90 patients recruited from 2 emergency department sites to test implementation and evaluation procedures. Findings from the feasibility study will be used to refine protocols for the larger trial. Study 2 is a cluster randomized controlled trial that will include 30 emergency department sites and 900 patients across British Columbia. The primary outcome of the randomized controlled trial will be emergency department revisits and hospital readmission rates. Secondary outcomes include health care resource utilization/costs, communication between members of the care team, and patient quality of life. Study 3 will run concurrently to study 2 and test the effectiveness of predictive analytic software to detect patient deterioration sooner. RESULTS:It is hypothesized that TEC4Home will be a cost-effective strategy to decrease 90-day emergency department revisits and hospital admission rates and improve comfort and quality of life for seniors with heart failure. The results from this project will also help establish an innovation pathway for rapid and rigorous introduction of innovation into the health system. CONCLUSIONS:While there is some evidence about the effectiveness of home telemonitoring for some patients and conditions, the TEC4Home project will be one of the first protocols that implements and evaluates the technology for patients with heart failure as they transition from the emergency department to home care. The results from this research are expected to inform the full scale and spread of the home monitoring approach throughout British Columbia and Canada and to other chronic diseases. CLINICALTRIAL:ClinicalTrials.gov NCT02821065; https://clinicaltrials.gov/ct2/show/NCT02821065 (Archived by WebCite at http://www.webcitation.org/6ml2iwKax).

Dataset Information

Designing meaningful outcome parameters using mobile technology: a new mobile application for telemonitoring of patients with heart failure.

Aims

Methods and results

Conclusions

Publications

Designing meaningful outcome parameters using mobile technology: a new mobile application for telemonitoring of patients with heart failure.

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