BackgroundPrevious 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.ObjectiveThe objective of this trial was to investigate the effects of a mobile phone-based telemonitoring system on heart failure management and outcomes.MethodsOne 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.ResultsBaseline 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.ConclusionsOur 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.Trial RegistrationClinicalTrials.gov NCT00778986
Reviews have repeatedly noted important methodological issues in the conduct and reporting of cluster randomized controlled trials (C-RCTs). These reviews usually focus on whether the intracluster correlation was explicitly considered in the design and analysis of the C-RCT. However, another important aspect requiring special attention in C-RCTs is the risk for imbalance of covariates at baseline. Imbalance of important covariates at baseline decreases statistical power and precision of the results. Imbalance also reduces face validity and credibility of the trial results. The risk of imbalance is elevated in C-RCTs compared to trials randomizing individuals because of the difficulties in recruiting clusters and the nested nature of correlated patient-level data. A variety of restricted randomization methods have been proposed as way to minimize risk of imbalance. However, there is little guidance regarding how to best restrict randomization for any given C-RCT. The advantages and limitations of different allocation techniques, including stratification, matching, minimization, and covariate-constrained randomization are reviewed as they pertain to C-RCTs to provide investigators with guidance for choosing the best allocation technique for their trial.
Volume 9November 18, 2002 Document Number 7 Purpose(1) The purpose of this paper is to construct a comprehensive framework of research dissemination and utilization that is useful for both health policy and clinical decision-making.
Organizational performance remains an elusive concept despite its importance to health care organizations' (HCOs') management and analysis. This paper uses Parsons' social system action theory to develop a comprehensive theoretically grounded framework by which to overcome the current fragmented approach to HCO performance management. The Parsonian perspective focuses on four fundamental functions that an HCO needs to ensure its survival. Organizational performance is determined by the dynamic equilibrium resulting from the continual interaction of, and interchange among, these four functions. The alignment interchanges allow the creation of bridges between traditional models of organizational performance that are usually used as independent and competing models. The attraction of the Parsonian model lies in its capacity to: (1) embody the various dominant models of organizational performance; (2) present a strong integrative framework in which the complementarity of various HCO performance perspectives are well integrated while their specificity is still well preserved; and (3) enrich the performance concept by making visible several dimensions of HCO performance that are usually neglected. A secondary objective of this paper is to lay the foundation for an integrative process of arbitration among competing indicators and perspectives which is absolutely necessary to make operational the Parsonian model of HCO performance. In this matter, we make reference to the theory of communicative action elaborated by Habermas. It offers, we think, a challenging and refreshing perspective on how to manage HCO performance evaluation processes.
BackgroundMobile phone-based remote patient monitoring systems have been proposed for heart failure management because they are relatively inexpensive and enable patients to be monitored anywhere. However, little is known about whether patients and their health care providers are willing and able to use this technology.ObjectiveThe objective of our study was to assess the attitudes of heart failure patients and their health care providers from a heart function clinic in a large urban teaching hospital toward the use of mobile phone-based remote monitoring.MethodsA questionnaire regarding attitudes toward home monitoring and technology was administered to 100 heart failure patients (94/100 returned a completed questionnaire). Semi-structured interviews were also conducted with 20 heart failure patients and 16 clinicians to determine the perceived benefits and barriers to using mobile phone-based remote monitoring, as well as their willingness and ability to use the technology.ResultsThe survey results indicated that the patients were very comfortable using mobile phones (mean rating 4.5, SD 0.6, on a five-point Likert scale), even more so than with using computers (mean 4.1, SD 1.1). The difference in comfort level between mobile phones and computers was statistically significant (P< .001). Patients were also confident in using mobile phones to view health information (mean 4.4, SD 0.9). Patients and clinicians were willing to use the system as long as several conditions were met, including providing a system that was easy to use with clear tangible benefits, maintaining good patient-provider communication, and not increasing clinical workload. Clinicians cited several barriers to implementation of such a system, including lack of remuneration for telephone interactions with patients and medicolegal implications.ConclusionsPatients and clinicians want to use mobile phone-based remote monitoring and believe that they would be able to use the technology. However, they have several reservations, such as potential increased clinical workload, medicolegal issues, and difficulty of use for some patients due to lack of visual acuity or manual dexterity.
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