Mobile Phone-Based Remote Patient Monitoring for Heart Failure Management: a Randomized Controlled Trial
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Abstract
Background
Remote patient monitoring of heart failure patients has been shown to be able to improve health outcomes. Mobile phones are becoming increasingly ubiquitous and economical, but the feasibility and efficacy of an mHealth remote monitoring system is still unknown. The objective of this randomized controlled trial was to determine the effects of a user-centric mobile phone-based remote monitoring system on heart failure outcomes, self-care, and clinical management.
Methods
One hundred heart failure patients were recruited from a large multidisciplinary Heart Function Clinic and randomized into the remote monitoring group (RM) and the control group (SC) who received standard care. The RM group (N=50) took daily weight and blood pressure readings, weekly single-lead ECGs, and answered daily symptom questions on a mobile phone for 6 months. Readings were automatically transmitted wirelessly to the mobile phone and then to data servers. Instructions were sent to the patient’s mobile phone and alerts were sent to a cardiologist’s mobile phone as required. During recruitment, all participants were asked to complete a baseline questionnaire (94 returned) and were interviewed. Post-study questionnaires were provided to all participants (84 returned), and 22 patients in the RM group and 5 clinicians were interviewed post-study.
Results
Approximately 70% of RM patients completed at least 80% of their daily readings over the 6 months. Quality of life measured with the Minnesota Living with Heart Failure Questionnaire improved only for the RM group (decrease of 9 points, p=.02). Heart function (left ventricular ejection fraction (LVEF)), heart failure prognosis (Brain Natriuretic Peptide (BNP) blood tests), and self-care (Self-Care of Heart Failure Index) improved for both the RM and SC groups. Being enrolled into the clinic was a confounder to the improvements from the monitoring system. Patients who were new to the clinic (enrolled less than 6 months) showed greater improvements when compared with the more stable patients who were enrolled into the clinic over 6 months (BNP p=.003; LVEF p=.02). A subgroup analysis, removing the 37 new patients from the total of 100 patients, found that only the RM group had significant improvements 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 10 points, p=.03). No differences were found between the RM and SC groups in terms of mortality, rehospitalization rates, or emergency department visits. The small sample size was a limitation of this study because it was underpowered to detect differences in these outcomes measures. The patient interviews revealed that the monitoring system helped patients improve their self-care knowledge and helped them to correlate and modify their lifestyle behavior according to changes in weight, blood pressure, and symptoms. Patients found the portability of the system to be beneficial, and several patients took the monitoring system on vacation. Clinicians thought the system helped them manage their patients, particularly through medication changes.
Conclusions
In summary, the findings from the trial have provided evidence of improved heart failure self-care, clinical management and health outcomes from mobile phone-based remote monitoring, which support the findings from recent meta-analyses. These results support the implementation and further research of such systems as a cost-effective and portable tool compared to traditional remote monitoring systems for heart failure management.
Remote patient monitoring of heart failure patients has been shown to be able to improve health outcomes. Mobile phones are becoming increasingly ubiquitous and economical, but the feasibility and efficacy of an mHealth remote monitoring system is still unknown. The objective of this randomized controlled trial was to determine the effects of a user-centric mobile phone-based remote monitoring system on heart failure outcomes, self-care, and clinical management.
Methods
One hundred heart failure patients were recruited from a large multidisciplinary Heart Function Clinic and randomized into the remote monitoring group (RM) and the control group (SC) who received standard care. The RM group (N=50) took daily weight and blood pressure readings, weekly single-lead ECGs, and answered daily symptom questions on a mobile phone for 6 months. Readings were automatically transmitted wirelessly to the mobile phone and then to data servers. Instructions were sent to the patient’s mobile phone and alerts were sent to a cardiologist’s mobile phone as required. During recruitment, all participants were asked to complete a baseline questionnaire (94 returned) and were interviewed. Post-study questionnaires were provided to all participants (84 returned), and 22 patients in the RM group and 5 clinicians were interviewed post-study.
Results
Approximately 70% of RM patients completed at least 80% of their daily readings over the 6 months. Quality of life measured with the Minnesota Living with Heart Failure Questionnaire improved only for the RM group (decrease of 9 points, p=.02). Heart function (left ventricular ejection fraction (LVEF)), heart failure prognosis (Brain Natriuretic Peptide (BNP) blood tests), and self-care (Self-Care of Heart Failure Index) improved for both the RM and SC groups. Being enrolled into the clinic was a confounder to the improvements from the monitoring system. Patients who were new to the clinic (enrolled less than 6 months) showed greater improvements when compared with the more stable patients who were enrolled into the clinic over 6 months (BNP p=.003; LVEF p=.02). A subgroup analysis, removing the 37 new patients from the total of 100 patients, found that only the RM group had significant improvements 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 10 points, p=.03). No differences were found between the RM and SC groups in terms of mortality, rehospitalization rates, or emergency department visits. The small sample size was a limitation of this study because it was underpowered to detect differences in these outcomes measures. The patient interviews revealed that the monitoring system helped patients improve their self-care knowledge and helped them to correlate and modify their lifestyle behavior according to changes in weight, blood pressure, and symptoms. Patients found the portability of the system to be beneficial, and several patients took the monitoring system on vacation. Clinicians thought the system helped them manage their patients, particularly through medication changes.
Conclusions
In summary, the findings from the trial have provided evidence of improved heart failure self-care, clinical management and health outcomes from mobile phone-based remote monitoring, which support the findings from recent meta-analyses. These results support the implementation and further research of such systems as a cost-effective and portable tool compared to traditional remote monitoring systems for heart failure management.
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