Dataset Information

Telemonitoring in patients with heart failure.

ABSTRACT: Small studies suggest that telemonitoring may improve heart-failure outcomes, but its effect in a large trial has not been established.We 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.The 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.Among 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.).

SUBMITTER: Chaudhry SI

PROVIDER: S-EPMC3237394 | biostudies-literature | 2010 Dec

REPOSITORIES: biostudies-literature

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Telemonitoring in patients with heart failure.

Chaudhry Sarwat I SI Mattera Jennifer A JA Curtis Jeptha P JP Spertus John A JA Herrin Jeph J Lin Zhenqiu Z Phillips Christopher O CO Hodshon Beth V BV Cooper Lawton S LS Krumholz Harlan M HM

The New England journal of medicine 20101116 24

<h4>Background</h4>Small studies suggest that telemonitoring may improve heart-failure outcomes, but its effect in a large trial has not been established.<h4>Methods</h4>We 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 ...[more]

PMID: 21080835

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Project description:The use of telemonitoring is a promising approach to optimizing outcomes in the treatment of heart failure (HF) for patients living in the community. HF telemonitoring interventions, however, have not been tested for use with individuals residing in disparity communities.The current study describes the results of a community based participatory research approach to adapting a telemonitoring HF intervention so that it is acceptable and feasible for use with a lower-income, Black and Hispanic patient population. The study uses the ADAPT-ITT framework to engage key community stakeholders in the process of adapting the intervention in the context of two consecutive focus groups. In addition, data from a third focus group involving HF telemonitoring patient participants was also conducted. All three focus group discussions were audio recorded and professionally transcribed and lasted approximately two hours each. Structural coding was used to mark responses to topical questions in the interview guide.This is the first study to describe the formative process of a community-based participatory research study aimed at optimizing telehealth utilization among African-American and Latino patients from disparity communities. Two major themes emerged from qualitative analyses of the focus group data. The first theme that arose involved suggested changes to the equipment that would maximize usability. Subthemes identified included issues that reflect the patient populations targeted, such as Spanish translation, font size and medical jargon. The second theme that arose involved suggested changes to the RCT study structure in order to maximize participant engagement. Subthemes also identified issues that reflect concerns of the targeted patient populations, such as the provision of reassurances regarding identity protection to undocumented patients in implementing an intervention that utilizes a camera, and that their involvement in telehealth monitoring would not replace their clinic care, which for many disparity patients is their only connection to medical care.The adaptation, based on the analysis of the data from the three focus groups, resulted in an intervention that is acceptable and feasible for HF patients residing in disparity communities.NCT02196922 ; ClinicalTrials.gov (US National Institutes of Health).

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.

Dataset Information

Telemonitoring in patients with heart failure.

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Telemonitoring in patients with heart failure.

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