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Health effectiveness and cost-effectiveness of telehealthcare for heart failure: study protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:Several heart failure studies have shown promising results for implementing telehealthcare. These studies have led to clinical and political interest in telehealthcare as a way to improve heart failure outcomes and lower costs. However, there is a need for large-scale clinical trials with cost-effectiveness assessments. METHODS/DESIGN:The present study is known as the TeleCare North Heart Failure Trial in Denmark. We are studying the health effectiveness and cost-effectiveness of a telehealth (Telekit) solution compared with usual care for patients with heart failure. The design is a multicenter, two-arm, parallel-group, nonblinded, superiority randomized controlled trial. Outpatient healthcare centers will be responsible for recruiting eligible participants (600 participants are expected) for the trial in the geographic area of the North Denmark Region. Participants are qualified for inclusion if they have been diagnosed according to national guidelines and are categorized in New York Heart Association class 2, 3, or 4. Patients must have a permanent residence and be motivated to use telehealth care. The primary outcomes are changes in health-related quality of life (assessed using the Kansas City Cardiomyopathy Questionnaire, the EuroQol EQ-5D-5L questionnaire, and the Short Form Health Survey [SF-36]) and in the incremental cost-effectiveness ratio measured from baseline to follow-up. The secondary outcomes are changes in mortality and in physiological indicators such as blood pressure, pulse, and weight. DISCUSSION:The TeleCare North Heart Failure Trial is intended to improve the international evidence base for the health effectiveness and cost-effectiveness of telehealthcare for patients with heart failure. The expectation is that the results of the trial can be generalized to all municipalities in Denmark and serve as an inspiration for further international research. TRIAL REGISTRATION:ClinicalTrials.gov ( NCT02860013 ). Registered on 28 July 2016.

SUBMITTER: Cichosz SL

PROVIDER: S-EPMC5154081 | biostudies-literature | 2016 Dec

REPOSITORIES: biostudies-literature

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Health effectiveness and cost-effectiveness of telehealthcare for heart failure: study protocol for a randomized controlled trial.

Cichosz Simon Lebech SL Ehlers Lars Holger LH Hejlesen Ole O

Trials 20161212 1

<h4>Background</h4>Several heart failure studies have shown promising results for implementing telehealthcare. These studies have led to clinical and political interest in telehealthcare as a way to improve heart failure outcomes and lower costs. However, there is a need for large-scale clinical trials with cost-effectiveness assessments.<h4>Methods/design</h4>The present study is known as the TeleCare North Heart Failure Trial in Denmark. We are studying the health effectiveness and cost-effect ...[more]

PMID: 27955682

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Project description:BackgroundSeveral feasibility studies show promising results of telehealthcare on health outcomes and health-related quality of life for patients suffering from chronic obstructive pulmonary disease, and some of these studies show that telehealthcare may even lower healthcare costs. However, the only large-scale trial we have so far - the Whole System Demonstrator Project in England - has raised doubts about these results since it conclude that telehealthcare as a supplement to usual care is not likely to be cost-effective compared with usual care alone.Methods/designThe present study is known as 'TeleCare North' in Denmark. It seeks to address these doubts by implementing a large-scale, pragmatic, cluster-randomized trial with nested economic evaluation. The purpose of the study is to assess the effectiveness and the cost-effectiveness of a telehealth solution for patients suffering from chronic obstructive pulmonary disease compared to usual practice. General practitioners will be responsible for recruiting eligible participants (1,200 participants are expected) for the trial in the geographical area of the North Denmark Region. Twenty-six municipality districts in the region define the randomization clusters. The primary outcomes are changes in health-related quality of life, and the incremental cost-effectiveness ratio measured from baseline to follow-up at 12 months. Secondary outcomes are changes in mortality and physiological indicators (diastolic and systolic blood pressure, pulse, oxygen saturation, and weight).DiscussionThere has been a call for large-scale clinical trials with rigorous cost-effectiveness assessments in telehealthcare research. This study is meant to improve the international evidence base for the effectiveness and cost-effectiveness of telehealthcare to patients suffering from chronic obstructive pulmonary disease by implementing a large-scale pragmatic cluster-randomized clinical trial.Trial registrationClinicaltrials.gov, http://NCT01984840, November 14, 2013.

Project description:BackgroundHeart failure (HF) is the leading cause of hospitalization among older adults in the United States. There are substantial racial and geographic disparities in HF outcomes, with patients living in southern US states having a mortality rate 69% higher than the national average. Self-management behaviors, particularly daily weight monitoring and physical activity, are extremely important in improving HF outcomes; however, patients typically have particularly low adherence to these behaviors. With the rise of digital technologies to improve health outcomes and motivate health behaviors, sensor-controlled digital games (SCDGs) have become a promising approach. SCDGs, which leverage sensor-connected technologies, offer the benefits of being portable and scalable and allowing for continuous observation and motivation of health behaviors in their real-world contexts. They are also becoming increasingly popular among older adults and offer an immersive and accessible way to measure self-management behaviors and improve adherence. No SCDGs have been designed for older adults or evaluated to test their outcomes.ObjectiveThis randomized clinical trial aims to assess the efficacy of a SCDG in integrating the behavioral data of participants with HF from weight scale and activity tracker sensors to activate game progress, rewards, and feedback and, ultimately, to improve adherence to important self-management behaviors.MethodsA total of 200 participants with HF, aged ≥45 years, will be recruited and randomized into 2 groups: the SCDG playing group (intervention group) and sensor-only group (control group). Both groups will receive a weight scale, physical activity tracker, and accompanying app, whereas only the intervention group will play the SCDG. This design, thereby, assesses the contributions of the game. All participants will complete a baseline survey as well as posttests at 6 and 12 weeks to assess the immediate effect of the intervention. They will also complete a third posttest at 24 weeks to assess the maintenance of behavioral changes. Efficacy and benefits will be assessed by measuring improvements in HF-related proximal outcomes (self-management behaviors of daily weight monitoring and physical activity) and distal outcomes (HF hospitalization, quality of life, and functional status) between baseline and weeks 6, 12, and 24. The primary outcome measured will be days with weight monitoring, for which this design provides at least 80% power to detect differences between the 2 groups.ResultsRecruitment began in the fall of 2022, and the first patient was enrolled in the study on November 7, 2022. Recruitment of the last participant is expected in quarter 1 of 2025. Publication of complete results and data from this study is expected in 2026.ConclusionsThis project will generate insight and guidance for scalable and easy-to-use digital gaming solutions to motivate persistent adherence to HF self-management behaviors and improve health outcomes among individuals with HF.Trial registrationClinicalTrials.gov NCT05056129; https://clinicaltrials.gov/ct2/show/NCT05056129.International registered report identifier (irrid)DERR1-10.2196/45801.

Project description:BackgroundPatients with multimorbidity and complex health needs are defined as a priority by the World Health Organization (WHO) and the European Union. There is a need to develop appropriate strategies with effective measures to meet the challenge of chronicity, reorienting national health systems. The increasing expansion of mobile health (mHealth) interventions in patient communication, the reduction of health inequalities, improved access to health care resources, adherence to treatment, and self-care of chronic diseases all point to an optimistic outlook. However, only few mobile apps demonstrate their effectiveness in these patients, which is diminished when they are not based on evidence, or when they are not designed by and for users with different levels of health literacy (HL).ObjectiveThis study aims to evaluate the efficacy of an mHealth intervention relative to routine clinical practice in improving HL and self-management in patients with multimorbidity with heart failure (HF) and complex health needs.MethodsThis is a randomized, multicenter, blinded clinical trial evaluating 2 groups, namely, a control group (standard clinical practice) and an intervention group (standard clinical practice and an ad hoc designed mHealth intervention previously developed), for 12 months.ResultsThe contents of the mHealth intervention will address user-perceived needs based on the development of user stories regarding diet, physical exercise, cardiac rehabilitation, therapeutic adherence, warning signs and symptoms, and emotional management. These contents have been validated by expert consensus. The creation and development of the contents of the mHealth intervention (app) took 18 months and was completed during 2021. The mobile app is expected to be developed by the end of 2022, after which it will be applied to the experimental group as an adjunct to standard clinical care during 12 months.ConclusionsThe trial will demonstrate whether the mobile app improves HL and self-management in patients with HF and complex health needs, improves therapeutic adherence, and reduces hospital admissions. This study can serve as a starting point for developing other mHealth tools in other pathologies and for their generalization to other contexts.Trial registrationClinicalTrials.gov NCT04725526; https://tinyurl.com/bd8va27w.International registered report identifier (irrid)DERR1-10.2196/35945.

Project description:BackgroundWorld-wide healthcare systems are faced with an epidemic of type 2 diabetes. In the United Kingdom, clinical care is primarily provided by general practitioners (GPs) rather than hospital specialists. Intermediate care clinics for diabetes (ICCD) potentially provide a model for supporting GPs in their care of people with poorly controlled type 2 diabetes and in their management of cardiovascular risk factors. This study aims to (1) compare patients with type 2 diabetes registered with practices that have access to an ICCD service with those that have access only to usual hospital care; (2) assess the cost-effectiveness of the intervention; and (3) explore the views and experiences of patients, health professionals and other stakeholders.Methods/designThis two-arm cluster randomized controlled trial (with integral economic evaluation and qualitative study) is set in general practices in three UK Primary Care Trusts. Practices are randomized to one of two groups with patients referred to either an ICCD (intervention) or to hospital care (control). Intervention group: GP practices in the intervention arm have the opportunity to refer patients to an ICCD - a multidisciplinary team led by a specialist nurse and a diabetologist. Patients are reviewed and managed in the ICCD for a short period with a goal of improving diabetes and cardiovascular risk factor control and are then referred back to practice. orControl groupStandard GP care, with referral to secondary care as required, but no access to ICCD. Participants are adults aged 18 years or older who have type 2 diabetes that is difficult for their GPs to control. The primary outcome is the proportion of participants reaching three risk factor targets: HbA1c (≤7.0%); blood pressure (<140/80); and cholesterol (<4 mmol/l), at the end of the 18-month intervention period. The main secondary outcomes are the proportion of participants reaching individual risk factor targets and the overall 10-year risks for coronary heart disease(CHD) and stroke assessed by the United Kingdom Prospective Diabetes Study (UKPDS) risk engine. Other secondary outcomes include body mass index and waist circumference, use of medication, reported smoking, emotional adjustment, patient satisfaction and views on continuity, costs and health related quality of life. We aimed to randomize 50 practices and recruit 2,555 patients.DiscussionForty-nine practices have been randomized, 1,997 patients have been recruited to the trial, and 20 patients have been recruited to the qualitative study. Results will be available late 2012.Trial registration[ClinicalTrials.gov: Identifier NCT00945204].

Project description:BackgroundInterventions focused on remote monitoring and social needs care have shown promise in improving clinical outcomes for patients with heart failure (HF). However, patient willingness to use technology as well as concerns about access in underresourced settings have limited digital platform implementation and adoption. There is little research in HF populations examining the effect of a combined digital and social needs care intervention that could enhance patient engagement in digital platform use while closing gaps in care related to social determinants of health. Here, we describe the protocol for a clinical trial of a digitally enabled community health worker intervention designed for patients with HF.ObjectiveThis study aims to describe the protocol for a randomized controlled trial assessing the acceptability, feasibility, and preliminary effectiveness of an intervention that combines remote monitoring with a digital platform and community health worker (CHW) social needs care for patients with HF who are transitioning from hospital to home. Given the elevated morbidity and mortality, identifying comprehensive and patient-centered interventions at the time of hospital care transitions that can improve clinical outcomes, impact cost, and augment the quality of care for this cohort is a priority.MethodsThis trial randomized adult inpatient participants (n=50) with a diagnosis of HF receiving care at a single academic health care institution to the 30-day intervention (digital platform+CHW pairing+usual care) or the 30-day control (CHW pairing+usual care) arms. All study participants completed baseline questionnaires and 30-day exit interviews and questionnaires. The primary outcomes will be acceptability, feasibility, and preliminary effectiveness.ResultsThis clinical trial opened for enrollment in September 2022 and was completed in June 2023. Initial results are expected to be published in the spring of 2024, and analysis is currently underway. Feasibility outcome measures will include the use rates of the biometric sensor (average hours per day), the digital blood pressure monitor (average times per day), the weight scale (average times per day), and the completion of the symptoms questionnaire (average times per day). The acceptability outcome will be measured by the patients' response to the truthfulness of the statement that they would be willing to use the digital platform in the future (response options: very true, somewhat true, or not true). Preliminary effectiveness will be measured by tracking 30-day clinical outcomes (hospital readmissions, emergency room visits, and missed primary care and cardiology appointments).ConclusionsThe results of this investigation are expected to contribute to our understanding of the use of digital interventions and the implementation of supportive home-based social needs care to enhance engagement and the potential effectiveness of clinically focused digital platforms. These results may inform the construction of a future multi-institutional trial designed to test the true effectiveness of this intervention in HF.Trial registrationClinicalTrials.gov NCT05130008; https://clinicaltrials.gov/study/NCT05130008.International registered report identifier (irrid)DERR1-10.2196/55687.

Project description:BACKGROUND:Cardiovascular disease is the leading cause of mortality worldwide, accounting for 13%-15% of all deaths. Cardiac rehabilitation has poor compliance and adherence. Telerehabilitation has been introduced to increase patients' participation, access, and adherence with the help of digital technologies. The target group is patients with heart failure. A telerehabilitation program called "Future Patient" has been developed and consists of three phases: (1) titration of medicine (0-3 months), (2) implementation of the telerehabilitation protocols (3 months), and (3) follow-up with rehabilitation in everyday life (6 months). Patients in the Future Patient program measure their blood pressure, pulse, weight, number of steps taken, sleep, and respiration and answer questions online regarding their well-being. All data are transmitted and accessed in the HeartPortal by patients and health care professionals. OBJECTIVE:The aim of this paper is to describe the research design, outcome measures, and data collection techniques in the clinical test of the Future Patient Telerehabilitation Program for patients with heart failure. METHODS:A randomized controlled study will be performed. The intervention group will follow the Future Patient Telerehabilitation program, and the control group will follow the traditional cardiac rehabilitation program. The primary outcome is quality of life measured by the Kansas City Cardiomyopathy Questionnaire. Secondary outcomes are development of clinical data; illness perception; motivation; anxiety and depression; health and electronic health literacy; qualitative exploration of patients', spouses', and health care professionals' experiences of participating in the telerehabilitation program; and a health economy evaluation of the program. Outcomes were assessed using questionnaires and through the data generated by digital technologies. RESULTS:Data collection began in December 2016 and will be completed in October 2019. The study results will be published in peer-reviewed journals and presented at international conferences. Results from the Future Patient Telerehabilitation program are expected to be published by the spring of 2020. CONCLUSIONS:The expected outcomes are increased quality of life, increased motivation and illness perception, reduced anxiety and depressions, improved electronic health literacy, and health economics benefits. We expect the study to have a clinical impact for future telerehabilitation of patients with heart failure. TRIAL REGISTRATION:ClinicalTrials.gov NCT03388918; https://clinicaltrials.gov/ct2/show/NCT03388918. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/14517.

Project description:BACKGROUND:People with hearing loss, particularly those who lose their hearing in adulthood, are at an increased risk of social isolation, mental health difficulties, unemployment, loss of independence, risk of accidents, and impaired quality of life. In the United Kingdom, a single third-sector organization provides hearing dogs, a specific type of assistance dog trained to provide sound support to people with hearing loss. These dogs may also deliver numerous psychosocial benefits to recipients. This has not previously been fully investigated. OBJECTIVE:The study aims to evaluate the impact of a hearing dog partnership on the lives of individuals with severe or profound hearing loss. METHODS:A 2-arm, randomized controlled trial will be conducted within the United Kingdom with 162 hearing dog applicants, aged 18 years and older. Participants will be randomized 1:1 using a matched-pairs design to receive a hearing dog sooner than usual (intervention arm: arm B) or to receive a hearing dog within the usual timeframe (comparator arm: arm A). In the effectiveness analysis, the primary outcome is a comparison of mental well-being 6 months after participants in arm B have received a hearing dog (arm A have not yet received a hearing dog), measured using the Short Warwick Edinburgh Mental Well-Being Scale. Secondary outcome measures include the Patient Health Questionnaire-9, Generalized Anxiety Disorder-7, and Work and Social Adjustments Scale. An economic evaluation will assess the cost-effectiveness, including health-related quality-adjusted life years using the EuroQol 5 Dimensions and social care-related quality-adjusted life years. Participants will be followed up for up to 2 years. A nested qualitative study will investigate the impacts of having a hearing dog and how these impacts occur. RESULTS:The study is funded by the National Institute for Health Research's School for Social Care Research. Recruitment commenced in March 2017 and is now complete. A total of 165 participants were randomized. Data collection will continue until January 2020. Results will be published in peer-reviewed journals and at conferences. A summary of the findings will be made available to participants. Ethical approval was received from the University of York's Department of Social Policy and Social Work Research Ethics Committee (reference SPSW/S/17/1). CONCLUSIONS:The findings from this study will provide, for the first time, strong and reliable evidence on the impact of having a hearing dog on people's lives in terms of their quality of life, well-being, and mental health. TRIAL REGISTRATION:International Standard Randomised Controlled Trial Number Registry ISRCTN36452009; http://www.isrctn.com/ISRCTN36452009. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/15452.

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Health effectiveness and cost-effectiveness of telehealthcare for heart failure: study protocol for a randomized controlled trial.

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Health effectiveness and cost-effectiveness of telehealthcare for heart failure: study protocol for a randomized controlled trial.

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