Summary of Clinical Research on Using Remote Patient Monitoring to Manage Heart Failure
Clinical Research Demonstrates RPM Improves Outcomes for Patients with Heart Failure
Heart failure (HF) affects approximately 6.2 million people in the United States and has a 5-year mortality rate of approximately 42%. The 30-day heart failure hospital readmission rate is 23%. In many cases, these readmissions are caused by factors such as blood pressure increases that could be avoided if proactively managed.
Clinical research shows that remote patient monitoring (RPM) using blood pressure monitors can reduce readmissions by enabling clinicians to intervene in a timely manner and proactively adjust treatment and/or medication at home. In addition, remote weight scales can be used to detect spikes in weight from fluid retention, an early sign of heart failure exacerbations.
Overall, the research indicates that remote monitoring is effective in reducing both rehospitalization and mortality. In addition, structured telephone support improved patient quality of life, self-care behaviors, heart failure knowledge, and overall satisfaction relative to patients without remote monitoring. Patients reported feeling more aware of their condition, more empowered to make appropriate lifestyle choices, and less anxiety.
In the research studies, clinicians reported they were able to manage their patients more effectively with access to more regular physiological data that enabled better decision-making for treatment and medication titration at an early stage of decompensation.
Research Highlights
- Overall, the 30-day hospital readmission rate was 10% (6/58 patients) for the Mount Sinai Heart Health RPM Program, compared with the national readmission rates of approximately 25% and the hospital’s average of approximately 23%. (source)
- Home telemonitoring reduced mortality (risk ratio = 0.64; 95% CI: 0.48-0.85) compared with usual care. (source)
- About 70% of telemonitoring patients completed at least 80% of their possible daily readings. These findings provide evidence of improved quality of life through improved self-care and clinical management from a mobile phone-based telemonitoring system. (source)
- Home telemonitoring interventions reduce the relative risk of all-cause mortality (0.60 to 0.85) and heart failure-related hospitalizations (0.64 to 0.86) compared with usual care. (source)
Older people with heart failure did benefit from structured telephone support and telemonitoring. Structured telephone support (RR 0.80; 95% CI=0.63-1.00) and telemonitoring (RR 0.56; 95% CI=0.41-0.76) interventions reduced mortality. Structured telephone support interventions reduced heart failure-related hospitalizations (RR 0.81; 95% CI=0.67-0.99). (source)
How to Use this Research
Physicians and ordering providers rely on the results of clinical research studies every day to make patient care decisions. If you have an existing RPM program or are considering launching one, these studies can be used to:
- Educating physicians on the clinical benefits of RPM
Justifying the investment of staff time and practice resources into launching or maintaining an RPM program
Improving RPM patient identification and onboarding based on patient populations that can benefit from RPM
Ready to Learn More about RPM
Clinical research has also demonstrated that RPM is effective for treating hypertension, diabetes, and more. If you want to talk to an RPM expert about the clinical and financial benefits of RPM, please schedule a free consultation.
Included Studies & Resources
Impact on Readmission Reduction Among Heart Failure Patients Using Digital Health Monitoring: Feasibility and Adoptability Study
Source: JMIR Medical Informatics
Home telemonitoring for congestive heart failure: a systematic review and meta-analysis
Source: Journal of Telemedicine and Telecare
Remote Monitoring of Patients With Heart Failure: An Overview of Systematic Reviews
Source: Journal of Medical Internet Research
Mobile phone-based telemonitoring for heart failure management: a randomized controlled trial
Source: Journal of Medical Internet Research
Effects of home telemonitoring interventions on patients with chronic heart failure: an overview of systematic reviews
Source: Journal of Medical Internet Research
Comparative Effectiveness of Telemonitoring Versus Usual Care for Heart Failure: A Systematic Review and Meta-analysis
Source: Journal of Cardiac Failure
Multicenter randomised trial on home-based telemanagement to prevent hospital readmission of patients with chronic heart failure
Source: International Journal of Cardiology
Which components of heart failure programmes are effective?
Source: European Journal of Heart Failure
Is age a factor in the success or failure of remote monitoring in heart failure? Telemonitoring and structured telephone support in elderly heart failure patients
Source: European Journal of Cardiovascular Nursing
Structured telephone support or non-invasive telemonitoring for patients with heart failure
Source: Cochrane Database of Systematic Review
Telemonitoring after discharge from hospital with heart failure: cost-effectiveness modelling of alternative service designs
Source: BMJ Open
Effect of home-based telemonitoring using mobile phone technology on the outcome of heart failure patients after an episode of acute decompensation: randomized controlled trial
Source: Journal of Medical Internet Research
Perceptions and experiences of heart failure patients and clinicians on the use of mobile phone-based telemonitoring
Source: Journal of Medical Internet Research
Source: JMIR Medical Informatics
Results: Overall, the Heart Health Program included 58 patients admitted to the Mount Sinai Hospital for HF. The 30-day hospital readmission rate was 10% (6/58), compared with the national readmission rates of approximately 25% and the Mount Sinai Hospital’s average of approximately 23%. Single marital status (P=.06) and history of percutaneous coronary intervention (P=.08) were associated with readmission. Readmitted patients were also less likely to have been previously prescribed angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers (P=.02). Notably, readmitted patients utilized the BP and weight monitors less than novvnreadmitted patients, and patients aged younger than 70 years used the monitors more frequently on average than those aged over 70 years, though these trends did not reach statistical significance. The percentage of the 58 patients using the monitors at least once dropped from 83% (42/58) in the first week after discharge to 46% (23/58) in the fourth week.
Conclusions: Given the increasing burden of HF, there is a need for an effective and sustainable remote monitoring system for HF patients following hospital discharge. The authors identified clinical and social factors as well as remote monitoring usage trends that identify targetable patient populations that could benefit most from integration of daily remote monitoring. In addition, the authors demonstrated that interventions driven by real-time vital sign data may greatly aid in reducing hospital readmissions and costs while improving patient outcomes.
Home telemonitoring for congestive heart failure: a systematic review and meta-analysis
Source: Journal of Telemedicine and Telecare
Summary: The authors conducted a systematic review of the literature about home telemonitoring compared with usual care. An electronic literature search was conducted to identify studies of home telemonitoring use in congestive heart failure (CHF) patients. Twenty-one original studies on home telemonitoring for patients with CHF were included (3082 patients). A random effects model was used to compute treatment efficacy to measure the average effect of the intervention across all studies where the quantitative pooling of results was appropriate. Home telemonitoring reduced mortality (risk ratio = 0.64; 95% CI: 0.48-0.85) compared with usual care. Several studies suggested that home telemonitoring also helped to lower the number of hospitalizations and the use of other health services. Patient quality of life and satisfaction with home telemonitoring were similar or better than with usual care.
More studies of higher methodological quality are required to give more precise information about the potential clinical effectiveness of home telehealth interventions.
Remote Monitoring of Patients With Heart Failure: An Overview of Systematic Reviews
Source: Journal of Medical Internet Research
Results: A total of 19 systematic reviews met their inclusion criteria. Reviews consisted of RPM with diverse interventions such as telemonitoring, home telehealth, mobile phone-based monitoring, and videoconferencing. All-cause mortality and heart failure mortality were the most frequently reported outcomes, but others such as quality of life, rehospitalization, emergency department visits, and length of stay were also reported. Self-care and knowledge were less commonly identified.
Conclusions: Telemonitoring and home telehealth appear generally effective in reducing heart failure rehospitalization and mortality. Other interventions, including the use of mobile phone-based monitoring and videoconferencing, require further investigation.
Mobile phone-based telemonitoring for heart failure management: a randomized controlled trial
Source: Journal of Medical Internet Research
Results: 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.
Conclusions: Their 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.
Source: Journal of Medical Internet Research
Results: A total of 15 reviews published between 2003 and 2013 were selected for meta-level synthesis. Evidence from high-quality reviews with meta-analysis indicated that taken collectively, home telemonitoring interventions reduce the relative risk of all-cause mortality (0.60 to 0.85) and heart failure-related hospitalizations (0.64 to 0.86) compared with usual care. Absolute risk reductions ranged from 1.4%-6.5% and 3.7%-8.2%, respectively. Improvements in HF-related hospitalizations appeared to be more pronounced in patients with stable HF: hazard ratio (HR) 0.70 (95% credible interval [Crl] 0.34-1.5]). Risk reductions in mortality and all-cause hospitalizations appeared to be greater in patients who had been recently discharged (≤28 days) from an acute care setting after a recent HF exacerbation: HR 0.62 (95% CrI 0.42-0.89) and HR 0.67 (95% CrI 0.42-0.97), respectively.
However, quality of evidence for these outcomes ranged from moderate to low suggesting that further research is very likely to have an important impact on the authors’ confidence in the observed estimates of effect and may change these estimates. The post-hoc analysis identified five main types of non-invasive telemonitoring technologies included in the systematic reviews: (1) video-consultation, with or without transmission of vital signs, (2) mobile telemonitoring, (3) automated device-based telemonitoring, (4) interactive voice response, and (5) Web-based telemonitoring.
Of these, only automated device-based telemonitoring and mobile telemonitoring were effective in reducing the risk of all-cause mortality and HF-related hospitalizations. More research data are required for interactive voice response systems, video-consultation, and Web-based telemonitoring to provide robust conclusions about their effectiveness.
Source: Journal of Cardiac Failure
Methods and results: The authors searched Ovid-Medline, Ovid-Embase, and the Cochrane Library for randomized controlled trials published through May 2016. Outcomes of interest included clinical effectiveness (mortality, hospitalization, and emergency department visits) and patient-reported outcomes. TM was defined as the transmission of individual biologic data, such as weight, blood pressure, and heart rate. Thirty-seven randomized controlled trials (9582 patients) of TM met the inclusion criteria: 24 studies on all-cause mortality, 17 studies on all-cause hospitalization, 12 studies on HF-related hospitalization, and 5 studies on HF-related mortality. The risks of all-cause mortality (risk ratio [RR] 0.81, 95% confidence interval [CI] 0.70-0.94) and HF-related mortality (RR 0.68, 95% CI 0.50-0.91) were significantly lower in the TM group than in the usual care group. TM showed a significant benefit when ≥3 biologic data are transmitted or when transmission occurred daily. TM also reduced mortality risk in studies that monitored patients’ symptoms, medication adherence, or prescription changes.
Conclusions: TM intervention reduces the mortality risk in patients with HF, and intensive monitoring with more frequent transmissions of patient data increases its effectiveness.
Source: International Journal of Cardiology
Methods and results: Four hundred-sixty CHF patients (pts), aged 57+/-10 years were randomised to two management strategies: 230 pts to HBT programme and 230 pts to UC programme. The HBT pts received a portable device, transferring, by telephone, a one-lead trace to a receiving station where a nurse was available for interactive teleconsultation. The UC pts were referred to their primary care 0.60 to mortality between groups. Mean cost for hospital readmission was significantly lower in HBT group (euro 843+/-1733) than in UC group (euro 1298+/-2322), (-35%, p<0.01).
Conclusions: This study suggests that one-year HBT programme reduce hospital readmissions and costs in CHF patients.
Source: PLOS One
Methods and findings: Systematic reviews (SR) of randomized controlled trials (RCTs) that examined telephone support, telemonitoring, video monitoring or electrocardiographic monitoring for HF patients were identified using a comprehensive search of the following databases: MEDLINE, EMBASE, CINAHL and The Cochrane Library. Studies were included if they reported the primary outcome of mortality or any of the following secondary outcomes: all-cause hospitalization and heart failure hospitalization. Thirty RCTs (N = 10,193 patients) were included. Compared to usual care, structured telephone support was found to reduce the odds of mortality (Odds Ratio 0.80; 95% Credible Intervals [0.66 to 0.96]) and hospitalizations due to heart failure (0.69; [0.56 to 0.85]).
Telemonitoring was also found to reduce the odds of mortality(0.53; [0.36 to 0.80]) and reduce hospitalizations related to heart failure (0.64; [0.39 to 0.95]) compared to usual post-discharge care. Interventions that involved ECG monitoring also reduced the odds of hospitalization due to heart failure (0.71; [0.52 to 0.98]).
Limitations: Much of the evidence currently available has focused on comparing either telephone support or telemonitoring with usual care. This has therefore limited our current understanding of how some of the less common forms of telemedicine compare to one another.
Conclusions: Compared to usual care, structured telephone support and telemonitoring significantly reduced the odds of deaths and hospitalization due to heart failure. Despite being the most widely studied forms of telemedicine, little has been done to directly compare these two interventions against one another. Further research into their comparative cost-effectiveness is also warranted.
Source: Heart
Results: Twenty-one RCTs that enrolled 6317 patients were identified (11 studies evaluated STS (10 of which were HH, while 1 was HM), 9 studies assessed TM, and 1 study assessed both STS and TM). No trial of implanted monitoring devices met the inclusion criteria.
Compared with usual care, although not reaching statistical significance, RM trended to reduce all-cause mortality for STS HH (HR: 0.77, 95% credible interval (CrI): 0.55, 1.08), TM during office hours (HR: 0.76, 95% CrI: 0.49, 1.18) and TM24/7 (HR: 0.49, 95% CrI: 0.20, 1.18). Exclusion of one trial that provided better-than-usual support to the control group rendered each of the above comparisons statistically significant. No beneficial effect on mortality was observed with STS HM. Reductions were also observed in all-cause hospitalisations for TM interventions but not for STS interventions. Care packages generally improved health-related quality-of-life and were acceptable to patients.
Conclusions: STS HH and TM with medical support provided during office hours showed beneficial trends, particularly in reducing all-cause mortality for recently discharged patients with heart failure. Where ‘usual’ care is less good, the impact of RM is likely to be greater.
Source: European Journal of Heart Failure
Methods and results: The authors searched all relevant electronic databases and search engines, hand-searched bibliographies of relevant studies, systematic reviews, and meeting abstracts. Two reviewers independently extracted all data. Randomized controlled trials comparing TM or STS to usual care in patients with CHF were included. Studies that included intensified management with additional home or clinic-visits were excluded. Primary outcomes (mortality and hospitalizations) were analysed; secondary outcomes (cost, length of stay, and quality of life) were tabulated. Thirty RCTs of STS and TM were identified (25 peer-reviewed publications (n= 8323) and five abstracts (n= 1482)).
Of the 25 peer-reviewed studies, 11 evaluated TM (2710 participants), 16 evaluated STS (5613 participants) with two testing both STS and TM in separate intervention arms compared with usual care. Telemonitoring reduced all-cause mortality {risk ratio (RR) 0.66 [95% confidence interval (CI) 0.54-0.81], P< 0.0001 }and STS showed a similar, but non-significant trend [RR 0.88 (95% CI 0.76-1.01), P= 0.08]. Both TM [RR 0.79 (95% CI 0.67-0.94), P= 0.008], and STS [RR 0.77 (95% CI 0.68-0.87), P< 0.0001] reduced CHF-related hospitalizations. Both interventions improved quality of life, reduced costs, and were acceptable to patients. Improvements in prescribing, patient-knowledge and self-care, and functional class were observed.
Conclusion: Telemonitoring and STS both appear effective interventions to improve outcomes in patients with CHF.
Source: European Journal of Cardiovascular Nursing
Results: The mean or median age of participants was 70 or more years in eight of the 16 (n=2659/5613; 47%) structured telephone support studies and four of the 11 (n=894/2710; 33%) telemonitoring studies. Structured telephone support (RR 0.80; 95% CI=0.63-1.00) and telemonitoring (RR 0.56; 95% CI=0.41-0.76) interventions reduced mortality. Structured telephone support interventions reduced heart failure-related hospitalizations (RR 0.81; 95% CI=0.67-0.99).
Conclusion: Despite a systematic bias towards recruitment of individuals younger than the epidemiological average into the randomized controlled trials, older people with heart failure did benefit from structured telephone support and telemonitoring. These post-hoc sub-analysis results were similar to overall effects observed in the main meta-analysis.
While further research is required to confirm these observational findings, the evidence at hand indicates that discrimination by age alone may be not be appropriate when inviting participation in a remote monitoring service for heart failure.
Structured telephone support or non-invasive telemonitoring for patients with heart failure
Source: Cochrane Database of Systematic Review
Authors’ conclusions: For people with heart failure, structured telephone support and non-invasive home telemonitoring reduce the risk of all-cause mortality and heart failure-related hospitalisations; these interventions also demonstrated improvements in health-related quality of life and heart failure knowledge and self-care behaviours. Studies also demonstrated participant satisfaction with the majority of the interventions which assessed this outcome.
Developing healthcare rule-based expert systems: case study of a heart failure telemonitoring system
Source: International Journal of Medical Informatics
Results: The developed expert system generated alerts and instructions based on the patient’s weight, blood pressure, heart rate, and symptoms. During the trial, 1620 alerts were generated, which led to various clinical actions including 105 medication changes/instructions. The findings from the trial indicated the rule set was associated with improved quality of life and self-care.
Conclusions: A rule set was developed with extensive input by heart failure clinicians. The results from the trial indicated the rule set was associated with significantly increased self-care and improved the clinical management of heart failure. The developed rule set can be used as a basis for other heart failure telemonitoring systems, but should be validated and modified as necessary. In addition, the process used to develop the rule set can be generalized and applied to create robust and complete rule sets for other healthcare expert systems.
Source: BMJ Open
Results: TM was the most cost-effective strategy in the scenario using these base case costs. Compared with usual care, TM had an estimated incremental cost effectiveness ratio (ICER) of £11 873/QALY, whereas STS HH had an ICER of £228 035/QALY against TM. STS HM was dominated by usual care. Threshold analysis suggested that the monthly cost of TM has to be higher than £390 to have an ICER greater than £20 000/QALY against STS HH. Scenario analyses performed using higher costs of usual care, higher costs of STS HH and lower costs of TM do not substantially change the conclusions.
Conclusions: Cost-effectiveness analyses suggest that TM was an optimal strategy in most scenarios, but there is considerable uncertainty in relation to clear descriptions of the interventions and robust estimation of costs.
Source: Journal of Medical Internet Research
Results: The study was stopped after randomization of 120 patients (85 male, 35 female); median age was 66 years (IQR 62-72). The control group comprised 54 patients (39 male, 15 female) with a median age of 67 years (IQR 61-72), and the tele group included 54 patients (40 male, 14 female) with a median age of 65 years (IQR 62-72). There was no significant difference between groups with regard to baseline characteristics. Twelve tele group patients were unable to begin data transmission due to the inability of these patients to properly operate the mobile phone (“never beginners”). Four patients did not finish the study due to personal reasons.
Intention-to-treat analysis at study end indicated that 18 control group patients (33%) reached the primary endpoint (1 death, 17 hospitalizations), compared with 11 tele group patients (17%, 0 deaths, 11 hospitalizations; relative risk reduction 50%, 95% CI 3-74%, P = .06). Per-protocol analysis revealed that 15% of tele group patients (0 deaths, 8 hospitalizations) reached the primary endpoint (relative risk reduction 54%, 95% CI 7-79%, P= .04). NYHA class improved by one class in tele group patients only (P< .001).
Tele group patients who were hospitalized for worsening heart failure during the study had a significantly shorter length of stay (median 6.5 days, IQR 5.5-8.3) compared with control group patients (median 10.0 days, IQR 7.0-13.0; P= .04). The event rate of never beginners was not higher than the event rate of control group patients.
Conclusions: Telemonitoring using mobile phones as patient terminals has the potential to reduce frequency and duration of heart failure hospitalizations. Providing elderly patients with an adequate user interface for daily data acquisition remains a challenging component of such a concept.
Source: Journal of Medical Internet Research
Results: 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.
Conclusions: 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.