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

Abstract

BackgroundSeveral 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/designThe 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.DiscussionThe 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 registrationClinicalTrials.gov (NCT02860013). Registered on 28 July 2016.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1722-5) contains supplementary material, which is available to authorized users.

Tele-monitoring Technology as a Tool for Monitoring and Management of Patients with Congestive Heart Failure

“…The duration period of the studies varied from 3 months to 3 years. Most of the studies used randomized control trials (Black et al, 2014;Blum & Gottlieb, 2014;Boyne et al, 2011;Cichosz, Ehlers & Hejlesen, 2016;Ferrante et al, 2010;Ong et al, 2016), and others are pre and post-study without using control group (Veenstra et al, 2015), prospective intervention study (Domingo et al, 2012), service-evaluation retrospective study (Eliat-Tsanani et al, 2016), observational study (Stut et al, 2015) and retrospective cohort study (Kao et al, 2016).…”

“…Eight papers (Boyne et al, 2011;Cichosz, Ehlers & Hejlesen, 2016;Domingo et al, 2012;Eliat-Tsanani et al, 2016;Ferrante et al, 2010;Ong et al, 2016;Stut et al, 2015;Veenstra et al, 2015 ) included patients suffering from NYHA II, III or IV. In the Heart Cycle study (Stut et al, 2015) the mean age of the patients is above 50 years and 66 % of the patients were classified as NYHA III.…”

“…In six papers (Black et al, 2014;Blum & Gottlieb, 2014;Stut et al, 2015;Eliat-Tsanani et al, 2016;Cichosz, Ehlers & Hejlesen, 2016;Ferrante et al, 2010) basic priority is the ability of the patient to handle the electronic devices. In addition, other five papers (Black et al, 2014;Stut et al, 2015;Kao et al, 2016;Domingo et al, 2012;Cichosz, Ehlers & Hejlesen, 2016) considered patients' socio-economic and cultural factors. In the study of Cichosz, Ehlers & Hejlesen (2016), only patients who can communicate in Danish language and be able to handle landline or mobile phone by themselves or have carers that can translate them about the use of telehealth system were included in the study.…”

“…In addition, other five papers (Black et al, 2014;Stut et al, 2015;Kao et al, 2016;Domingo et al, 2012;Cichosz, Ehlers & Hejlesen, 2016) considered patients' socio-economic and cultural factors. In the study of Cichosz, Ehlers & Hejlesen (2016), only patients who can communicate in Danish language and be able to handle landline or mobile phone by themselves or have carers that can translate them about the use of telehealth system were included in the study. In BEAT-HF study (Black et al, 2014;Ong et al, 2016), patients speaking English, Spanish, Farsi or Russian were included.…”

Is telehealthcare for heart failure patients cost-effective? An economic evaluation alongside the Danish TeleCare North heart failure trial

“…In this respect, the North Denmark Region has played a major role in the formulation of the national strategy by performing prelaunch, large-scale randomised controlled trials and health economic evaluations and national business cases as decision-support for the nationwide implementation 23 24. In the wake of the first TeleCare North trial directed at patients suffering from chronic obstructive pulmonary disease (COPD), which was executed in 2014 to 2015,23 24 the TeleCare North Heart Failure (HF) trial was launched in 2016 with the purpose of evaluating the effectiveness and cost-effectiveness of a telehealthcare solution directed at patients with HF 25. The purpose of this economic evaluation is to evaluate the cost-effectiveness of the TeleCare North HF solution, comparing the impact on costs and effects (ie, quality-adjusted life-years (QALYs)) with that of the usual practice for the treatment of HF in Denmark.…”