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A Mobile Phone-Based Telemonitoring Program for Heart Failure Patients After an Incidence of Acute Decompensation (Medly-AID): Protocol for a Randomized Controlled Trial.

ABSTRACT: BACKGROUND:Patients with heart failure (HF) are at the highest risk for hospital readmissions during the first few weeks after discharge when patients are transitioning from hospital to home. Telemonitoring (TM) for HF management has been found to reduce mortality risk and hospital readmissions if implemented appropriately; however, the impact of TM targeted for patients recently discharged from hospital, for whom TM might have the biggest benefit, is still unknown. Medly, a mobile phone-based TM system that is currently being used as a standard of care for HF at a large Canadian hospital, may be an effective tool for the management of HF in patients recently discharged from hospital. OBJECTIVE:The objective of the Medly-After an Incidence of acute Decompensation (Medly-AID) trial is to determine the effect of Medly on the self-care and quality of life of patients with HF who have been recently discharged from hospital after an HF-related decompensation. METHODS:A multisite multimethod randomized controlled trial (RCT) will be conducted at 2 academic hospitals and at least one community hospital to evaluate the impact of Medly-enabled HF management on the outcomes of patients with HF who had been hospitalized for HF-related decompensation and discharged during the 2 weeks before recruitment. The trial will include 144 participants with HF (74 in each control and intervention groups). Control patients will receive standard of care, whereas patients in the intervention group will receive standard of care and Medly. Specifically, patients in the intervention group will record daily weight, blood pressure, and heart rate and answer symptom-related questions via the Medly app. Medly will generate automated patient self-care messages such as to adjust diuretic medications, based on the rules-based algorithm personalized to the individual patient, and send real-time alerts to their health care providers as necessary. All patients will be followed for 3 months. Primary outcome measures are self-care and quality of life as measured through the validated questionnaires Self-Care of Heart Failure Index, EQ-5D-5L, and the Kansas City Cardiomyopathy Questionnaire-12. Secondary outcome measures for this study include cost of health care services used and health outcomes. RESULTS:Patient recruitment began in November 2018 at the Sunnybrook Health Sciences Centre, with a total of 35 participants recruited by July 30, 2019 (17 in the intervention group and 18 in the control group). The final analysis is expected to occur in the fall of 2020. CONCLUSIONS:This RCT will be the first to assess the effectiveness of the Medly TM system for use following discharge from hospital after a HF-related decompensation. TRIAL REGISTRATION:ClinicalTrials.gov NCT03358303; https://clinicaltrials.gov/ct2/show/NCT03358303. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/15753.

SUBMITTER: Seto E

PROVIDER: S-EPMC7003117 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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A Mobile Phone-Based Telemonitoring Program for Heart Failure Patients After an Incidence of Acute Decompensation (Medly-AID): Protocol for a Randomized Controlled Trial.

Seto Emily E Ross Heather H Tibbles Alana A Wong Steven S Ware Patrick P Etchells Edward E Kobulnik Jeremy J Chibber Tamanna T Poon Stephanie S

JMIR research protocols 20200122 1

<h4>Background</h4>Patients with heart failure (HF) are at the highest risk for hospital readmissions during the first few weeks after discharge when patients are transitioning from hospital to home. Telemonitoring (TM) for HF management has been found to reduce mortality risk and hospital readmissions if implemented appropriately; however, the impact of TM targeted for patients recently discharged from hospital, for whom TM might have the biggest benefit, is still unknown. Medly, a mobile phone ...[more]

PMID: 32012116

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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: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:BackgroundThere is a strong will and need to find alternative models of health care delivery driven by the ever-increasing burden of chronic diseases.ObjectiveThe purpose of this 1-year trial was to study whether a structured mobile phone-based health coaching program, which was supported by a remote monitoring system, could be used to improve the health-related quality of life (HRQL) and/or the clinical measures of type 2 diabetes and heart disease patients.MethodsA randomized controlled trial was conducted among type 2 diabetes patients and heart disease patients of the South Karelia Social and Health Care District. Patients were recruited by sending invitations to randomly selected patients using the electronic health records system. Health coaches called patients every 4 to 6 weeks and patients were encouraged to self-monitor their weight, blood pressure, blood glucose (diabetics), and steps (heart disease patients) once per week. The primary outcome was HRQL measured by the Short Form (36) Health Survey (SF-36) and glycosylated hemoglobin (HbA1c) among diabetic patients. The clinical measures assessed were blood pressure, weight, waist circumference, and lipid levels.ResultsA total of 267 heart patients and 250 diabetes patients started in the trial, of which 246 and 225 patients concluded the end-point assessments, respectively. Withdrawal from the study was associated with the patients' unfamiliarity with mobile phones—of the 41 dropouts, 85% (11/13) of the heart disease patients and 88% (14/16) of the diabetes patients were familiar with mobile phones, whereas the corresponding percentages were 97.1% (231/238) and 98.6% (208/211), respectively, among the rest of the patients (P=.02 and P=.004). Withdrawal was also associated with heart disease patients' comorbidities—40% (8/20) of the dropouts had at least one comorbidity, whereas the corresponding percentage was 18.9% (47/249) among the rest of the patients (P=.02). The intervention showed no statistically significant benefits over the current practice with regard to health-related quality of life—heart disease patients: beta=0.730 (P=.36) for the physical component score and beta=-0.608 (P=.62) for the mental component score; diabetes patients: beta=0.875 (P=.85) for the physical component score and beta=-0.770 (P=.52) for the mental component score. There was a significant difference in waist circumference in the type 2 diabetes group (beta=-1.711, P=.01). There were no differences in any other outcome variables.ConclusionsA health coaching program supported with telemonitoring did not improve heart disease patients' or diabetes patients' quality of life or their clinical condition. There were indications that the intervention had a differential effect on heart patients and diabetes patients. Diabetes patients may be more prone to benefit from this kind of intervention. This should not be neglected when developing new ways for self-management of chronic diseases.Trial registrationClinicalTrials.gov NCT01310491; http://clinicaltrials.gov/ct2/show/NCT01310491 (Archived by WebCite at http://www.webcitation.org/6Z8l5FwAM).

Project description:BackgroundWith an explosive growth in mobile health, an estimated 500 million patients are potentially using mHealth apps for supporting health and self-care of chronic diseases. Therefore, this review focused on mHealth apps for use among patients with heart failure.ObjectiveThe aim of this integrative review was to identify and assess the functionalities of mHealth apps that provided usability and efficacy data and apps that are commercially available without supporting data, all of which are to support heart failure self-care management and thus impact heart failure outcomes.MethodsA search of published, peer-reviewed literature was conducted for studies of technology-based interventions that used mHealth apps specific for heart failure. The initial database search yielded 8597 citations. After filters for English language and heart failure, the final 487 abstracts was reviewed. After removing duplicates, a total of 18 articles that tested usability and efficacy of mobile apps for heart failure self-management were included for review. Google Play and Apple App Store were searched with specified criteria to identify mHealth apps for heart failure. A total of 26 commercially available apps specific for heart failure were identified and rated using the validated Mobile Application Rating Scale.ResultsThe review included studies with low-quality design and sample sizes ranging from 7 to 165 with a total sample size of 847 participants from all 18 studies. Nine studies assessed usability of the newly developed mobile health system. Six of the studies included are randomized controlled trials, and 4 studies are pilot randomized controlled trials with sample sizes of fewer than 40. There were inconsistencies in the self-care components tested, increasing bias. Thus, risk of bias was assessed using the Cochrane Collaboration's tool for risk of selection, performance, detection, attrition, and reporting biases. Most studies included in this review are underpowered and had high risk of bias across all categories. Three studies failed to provide enough information to allow for a complete assessment of bias, and thus had unknown or unclear risk of bias. This review on the commercially available apps demonstrated many incomplete apps, many apps with bugs, and several apps with low quality.ConclusionsThe heterogeneity of study design, sample size, intervention components, and outcomes measured precluded the performance of a systematic review or meta-analysis, thus introducing bias of this review. Although the heart failure-related outcomes reported in this review vary, they demonstrated trends toward making an impact and offer a potentially cost-effective solution with 24/7 access to symptom monitoring as a point of care solution, promoting patient engagement in their own home care.

Project description:BackgroundHeart failure (HF) is a major public health issue in Canada that is associated with high prevalence, morbidity, and mortality rates and high financial and social burdens. Telemonitoring (TM) has been shown to improve all-cause mortality and hospitalization rates in patients with HF. The Medly program is a TM intervention integrated as standard of care at a large Canadian academic hospital for ambulatory patients with HF that has been found to improve patient outcomes. However, the cost-effectiveness of the Medly program is yet to be determined.ObjectiveThis study aims to conduct a cost-utility analysis of the Medly program compared with the standard of care for HF in Ontario, Canada, from the perspective of the public health care payer.MethodsUsing a microsimulation model, individual patient data were simulated over a 25-year time horizon to compare the costs and quality-adjusted life years (QALYs) between the Medly program and standard care for patients with HF treated in the ambulatory care setting. Data were sourced from a Medly Program Evaluation study and literature to inform model parameters, such as Medly's effectiveness in reducing mortality and hospitalizations, health care and intervention costs, and model transition probabilities. Scenario analyses were conducted in relation to HF severity and TM deployment models. One-way deterministic effectiveness analysis and probabilistic sensitivity analysis were performed to explore the impact on the results of uncertainty in model parameters.ResultsThe Medly program was associated with an average total cost of Can $102,508 (US $77,626) per patient and total QALYs of 5.51 per patient compared with the average cost of Can $97,497 (US $73,831) and QALYs of 4.95 per patient in the Standard Care Group. This led to an incremental cost of Can $5011 (US $3794) and incremental QALY of 0.566, resulting in an incremental cost-effectiveness ratio of Can $8850 (US $6701)/QALY. Cost-effectiveness improved in relation to patients with advanced HF and with deployment models in which patients used their own equipment. Baseline and alternative scenarios consistently showed probabilities of cost-effectiveness greater than 85% at a willingness-to-pay threshold of Can $50,000 (US $37,718). Although the results showed some sensitivity to assumptions about effectiveness parameters, the intervention was found to remain cost-effective.ConclusionsThe Medly program for patients with HF is cost-effective compared with standard care using commonly reported willingness-to-pay thresholds. This study provides evidence for decision makers on the use of TM for HF, supports the use of a nurse-led model of TM that embeds clinically validated algorithms, and informs the use of economic modeling for future evaluations of early-stage health informatics technology.

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:BackgroundTelemonitoring enables care providers to remotely support outpatients in self-managing chronic heart failure (CHF), but little is known about the usability and patients' willingness to engage with this technology.ObjectiveThis study aims to evaluate feedback from patients with CHF following participation in the Innovative Telemonitoring Enhanced Care program for CHF (ITEC-CHF) study.MethodsThe telemonitoring intervention consisted of three components: remote weight monitoring, structured telephone support, and nurse-led collaborative care. Participants were provided with electronic weighing scales (W550; ForaCare), and a computer tablet (Galaxy Tab A; Samsung). They were asked to weigh themselves on the provided scales daily. Telemonitoring was integrated with a personal assistance call service and a nurse care service according to their workflows in usual care. Feedback on the usability of ITEC-CHF was collected via survey from study participants following 6 months of receiving telemonitoring care for their body weight. Survey responses were provided on a 5-point Likert scale and through open-ended questions to determine participants' perceived benefits and barriers to using ITEC-CHF.ResultsA total of 67 participants (49/67, 73% male), with a mean age of 69.8 (SD 12.4) years completed the survey. The majority of participants agreed or strongly agreed that the ITEC-CHF program was easy to use (61/67, 91%), easy to navigate (51/65, 78%), useful (59/65, 91%), and made them feel more confident in managing their weight (57/67, 85%). Themes related to participants' perceptions of telemonitoring included increased support for early intervention of clinical deterioration, improved compliance to daily weighing, a sense of reassurance, and improved self-care and accountability, among others.ConclusionsITEC-CHF was rated highly on usability and was well accepted by users as part of their routine self-management activities. Participants were willing to use telemonitoring because they perceived a broad spectrum of benefits for CHF management.Trial registrationAustralian New Zealand Clinical Trial Registry ID ACTRN 12614000916640; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366691.

Dataset Information

A Mobile Phone-Based Telemonitoring Program for Heart Failure Patients After an Incidence of Acute Decompensation (Medly-AID): Protocol for a Randomized Controlled Trial.

Publications

A Mobile Phone-Based Telemonitoring Program for Heart Failure Patients After an Incidence of Acute Decompensation (Medly-AID): Protocol for a Randomized Controlled Trial.

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