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The Effects of Telemonitoring on Patient Compliance With Self-Management Recommendations and Outcomes of the Innovative Telemonitoring Enhanced Care Program for Chronic Heart Failure: Randomized Controlled Trial.

ABSTRACT: BACKGROUND:Telemonitoring enables care providers to remotely support outpatients in self-managing chronic heart failure (CHF), but the objective assessment of patient compliance with self-management recommendations has seldom been studied. OBJECTIVE:This study aimed to evaluate patient compliance with self-management recommendations of an innovative telemonitoring enhanced care program for CHF (ITEC-CHF). METHODS:We conducted a multicenter randomized controlled trial with a 6-month follow-up. The ITEC-CHF program comprised the provision of Bluetooth-enabled scales linked to a call center and nurse care services to assist participants with weight monitoring compliance. Compliance was defined a priori as weighing at least 4 days per week, analyzed objectively from weight recordings on the scales. The intention-to-treat principle was used to perform the analysis. RESULTS:A total of 184 participants (141/184, 76.6% male), with a mean age of 70.1 (SD 12.3) years, were randomized to receive either ITEC-CHF (n=91) or usual care (control; n=93), of which 67 ITEC-CHF and 81 control participants completed the intervention. For the compliance criterion of weighing at least 4 days per week, the proportion of compliant participants in the ITEC-CHF group was not significantly higher than that in the control group (ITEC-CHF: 67/91, 74% vs control: 56/91, 60%; P=.06). However, the proportion of ITEC-CHF participants achieving the stricter compliance standard of at least 6 days a week was significantly higher than that in the control group (ITEC-CHF: 41/91, 45% vs control: 23/93, 25%; P=.005). CONCLUSIONS:ITEC-CHF improved participant compliance with weight monitoring, although the withdrawal rate was high. Telemonitoring is a promising method for supporting both patients and clinicians in the management of CHF. However, further refinements are required to optimize this model of care. TRIAL REGISTRATION:Australian New Zealand Clinical Trial Registry ACTRN12614000916640; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366691.

SUBMITTER: Ding H

PROVIDER: S-EPMC7381046 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

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The Effects of Telemonitoring on Patient Compliance With Self-Management Recommendations and Outcomes of the Innovative Telemonitoring Enhanced Care Program for Chronic Heart Failure: Randomized Controlled Trial.

Ding Hang H Jayasena Rajiv R Chen Sheau Huey SH Maiorana Andrew A Dowling Alison A Dowling Alison A Layland Jamie J Good Norm N Karunanithi Mohanraj M Edwards Iain I

Journal of medical Internet research 20200708 7

<h4>Background</h4>Telemonitoring enables care providers to remotely support outpatients in self-managing chronic heart failure (CHF), but the objective assessment of patient compliance with self-management recommendations has seldom been studied.<h4>Objective</h4>This study aimed to evaluate patient compliance with self-management recommendations of an innovative telemonitoring enhanced care program for CHF (ITEC-CHF).<h4>Methods</h4>We conducted a multicenter randomized controlled trial with a ...[more]

PMID: 32673222

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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.

Project description:BackgroundThe management of heart failure (HF) is challenging because of the complexities in recommended therapies. Integrated disease management (IDM) is an effective model, promoting guideline-directed care, but the impact of IDM in the community setting requires further evaluation.MethodsA retrospective evaluation of community-based IDM. Patient characteristics were described, and outcomes using a pre- and post-intervention design were HF-related health-service use, quality of life, and concordance with guideline-directed medical therapy (GDMT).Results715 patients were treated in the program (2016 to 2023), 219 in a community specialist-care clinic, and 496 in 25 primary-care clinics. The overall cohort was predominantly male (60%), with a mean age of 73.5 years (± 10.7), and 60% with HF with reduced ejection fraction. In patients with ≥ 6 months of follow-up (n = 267), pre vs post annualized rates of HF-related acute health-service use decreased from 36.3 to 8.5 hospitalizations per 100 patients per year, P < 0.0001, from 31.8 to 13.1 emergency department visits per 100 patients per year, P < 0.0001, and from 152.8 to 110.0 urgent physician visits per 100 patients per year, P = 0.0001. The level of concordance with GDMT improved; the number of patients receiving triple therapy and quadruple therapy increased by 10.1% (95% confidence interval [CI], 2.4%,17.8%) and 19.6% (95% CI, 12.0%, 27.3%), respectively. Within these groups, optimal dosing was achieved in 42.5% (95% CI, 32.0%, 53.6%) and 35.0% (95% CI, 23.1%, 48.4%), respectively. In patients with at least one follow-up visit (n = 286), > 50% experienced a clinically relevant improvement in their quality of life.ConclusionsA community-based IDM program for HF, may reduce HF-related acute health-service use, improve quality of life and level of concordance with GDMT. These encouraging preliminary outcomes from a real-world program evaluation require confirmation in a randomized controlled trial.

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:BACKGROUND:Heart failure (HF) is associated with frequent exacerbations and shortened lifespan. Informal caregivers such as significant others often support self-management in patients with HF. However, existing programs that aim to enhance self-management seldom engage informal caregivers or provide tools that can help alleviate caregiver burden or improve collaboration between patients and their informal caregivers. OBJECTIVE:To develop and pilot test a program targeting the needs of self-management support among HF patients as well as their significant others. METHODS:We developed the Dyadic Health Behavior Change model and conducted semi-structured interviews to determine barriers to self-management from various perspectives. Participants' feedback was used to develop a family-centered self-management program called "SUCCEED: Self-management Using Couples' Coping EnhancEment in Diseases." The goals of this program are to improve HF self-management, quality of life, communication within couples, relationship quality, and stress and caregiver burden. We conducted a pilot study with 17 Veterans with HF and their significant others to determine acceptability of the program. We piloted psychosocial surveys at baseline and after participants' program completion to evaluate change in depressive symptoms, caregiver burden, self-management of HF, communication, quality of relationship, relationship mutuality, and quality of life. RESULTS:Of the 17 couples, 14 completed at least 1 SUCCEED session. Results showed high acceptability for each of SUCCEED's sessions. At baseline, patients reported poor quality of life, clinically significant depressive symptoms, and inadequate self-management of HF. After participating in SUCCEED, patients showed improvements in self-management of HF, communication, and relationship quality, while caregivers reported improvements in depressive symptoms and caregiver burden. Quality of life of both patients and significant others declined over time. CONCLUSION:In this small pilot study, we showed positive trends with involving significant others in self-management. SUCCEED has the potential of addressing the growing public health problem of HF among patients who receive care from their significant other.

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.).

Dataset Information

The Effects of Telemonitoring on Patient Compliance With Self-Management Recommendations and Outcomes of the Innovative Telemonitoring Enhanced Care Program for Chronic Heart Failure: Randomized Controlled Trial.

Publications

The Effects of Telemonitoring on Patient Compliance With Self-Management Recommendations and Outcomes of the Innovative Telemonitoring Enhanced Care Program for Chronic Heart Failure: Randomized Controlled Trial.

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