Telemedicine in heart failure: Pre-specified and exploratory subgroup analyses from the TIM-HF trial☆,☆☆
Introduction
The number of patients with chronic heart failure (HF) continues to increase worldwide, and this syndrome exerts a substantial burden on society and on healthcare systems in terms of morbidity, mortality and high consumption of resources primarily caused by repeated and in some instances, lengthy hospital stays [1], [2]. Chronic HF is a multifaceted condition and the evolution of its medical management over the past two decades, from the 90's in particular, reflects the understanding of the underlying patho-physiology of this diagnosis and the results of randomised clinical trials have shown that selective poly-therapy for patients with mild-to-moderate heart failure reduces its progression and mortality risk [3].
In recent years, the focus for the management of chronic HF has shifted as developments in modern telecommunication technologies have created new options to deliver telemedical care as an adjunct to the medical management of HF patients [4]. It has been suggested that well structured out-patient care may prevent the need for hospitalisation, facilitate early intervention thus preventing ‘crisis’ management, prevent complications or the progression to a more severe disease status [5]. Recent meta-analyses [6], [7], [8] have shown that telemedical monitoring in chronic HF can reduce total mortality during a follow-up of 6 to 12 months in addition to reducing the number and duration of hospitalisations for worsening HF. Since the publication of these meta-analyses, two recently reported prospectively conducted randomised multi-centre clinical trials do not corroborate these findings [9], [10].
These contrasting results pose a challenge to the medical profession as the answers to the following issues need to be re-addressed: Does remote telemedical management (RTM) have a role in the management of HF patients? If yes, which HF population is most likely to benefit from this intervention, which type of telemedical support is warranted and which clinically meaningful outcome can be positively affected by this intervention? In this report, we address two of these challenges, namely how the potential HF population which could benefit from RTM could be identified and which outcome could be the most meaningful to use for this intervention from a clinical perspective. To this end, we present the results of the prospectively defined subgroup analyses and two additional post hoc analyses from the Telemedical Interventional Monitoring in Heart Failure (TIM-HF trial) [10], [11].
Section snippets
Trial design
A description of the TIM-HF study design in addition to the main results has been published elsewhere [11]. Briefly, between January 2008 and June 2009, 710 eligible patients with chronic HF were enrolled in 165 cardiology, internal medicine or general medicine practices in Germany. Patients were randomly allocated (1:1) to either RTM or to usual care and were followed for a minimum of 12 months with out-patient visits at 3, 6, 9 and 12 months during the first year and at 18 and 24 months in the
Results
As reported previously [10], a total of 710 patients with chronic HF were enrolled in the TIM-HF study with 354 patients randomly assigned to the RTM group and 356 to the usual care group. The median follow-up was 26 months (mean 21.5 months). Of the 354 patients randomly assigned to receive RTM, 287 (81%) were at least 70% compliant with the daily transfer of data to the telemedicine centres and had no break in information transfer > 30 days (except during hospitalisations) [10]. Overall, patient
Discussion
For the prospectively defined subgroups, the subgroup treatment effects were significant for total mortality for the PHQ-9 subgroup (p for interaction < 0.027) only. For the outcome days lost due to HF hospitalisation and death (all cause), the subgroup treatment effects were significant (p for interaction < 0.05) for patients with a prior history of HF decompensation or an ICD implant or a PHQ score of < 10 and for the patient-profiling subgroup. For this subgroup, subgroup treatment effects (p for
Conclusion
Heart failure is a dynamic disease. Improvements in the out-patient management of patients with chronic HF are needed to address the increasing burden of worsening HF requiring re-admission to hospital. Going forward, the role of telemedicine management as an adjunct intervention in HF management needs to be investigated in future, well designed randomised clinical trials. The latter should focus on the target population most likely to benefit from this intervention and use the most clinically
Conflict of interest
SDA is consultant for Robert Bosch Healthcare GmbH, Thermo Fisher Scientific Germany and St. Jude Medical GmbH and received honoraria for speaking from Thermo Fisher Scientific Germany and St. Jude Medical GmbH.
No other potential conflict of interest relevant to this article was reported.
Acknowledgement
We thank all TIM-Investigators, nurses and staff at the study sites and especially all of the patients involved in the TIM-HF trial.
We would also like to acknowledge
Birgit Bott (German Aerospace Centre (DLR) Project Management Agency Convergent ICT / Multimedia on behalf of the German Federal Ministry of Economics and Technology (BMWi) for consulting in the project management)
Martin Braecklein (Robert Bosch Healthcare GmbH, Waiblingen, Germany) for the leadership in the technical project
References (18)
- et al.
A meta-analysis of remote monitoring of heart failure patients
J Am Coll Cardiol
(2009) - et al.
Noninvasive home telemonitoring for patients with heart failure at high risk of recurrent admission and death: the Trans-European Network-Home-Care Management System (TEN-HMS) study
J Am Coll Cardiol
(2005) - et al.
Ethics in the authorship and publishing of scientific articles
Int J Cardiol
(2010) - et al.
Heart disease and stroke statistics—2010 update: a report from the American Heart Association
Circulation
(2010) - et al.
Recent national trends in readmission rates after heart failure hospitalization
Circ Heart Fail
(2010) - et al.
The association between long-term longitudinal trends in guideline adherence and mortality in relation to age and sex
Eur J Heart Fail
(2010) - et al.
Enlisting the help of the largest health care workforce—patients
JAMA
(2010) - Agency for Healthcare Research and Quality. Appendix B. Ambulatory care sensitive conditions. Agency for Healthcare...
- et al.
Telemonitoring or structured telephone support programmes for patients with chronic heart failure: systematic review and meta-analysis
BMJ
(2007)
Cited by (79)
A Contemporary Review of Community and Transitional Heart Failure Programs
2023, Journal for Nurse PractitionersMobile health applications in cardiovascular research
2018, International Journal of CardiologyEfficacy of telemedical interventional management in patients with heart failure (TIM-HF2): a randomised, controlled, parallel-group, unmasked trial
2018, The LancetCitation Excerpt :We used data for specific subgroups from the TIM-HF trial for sample size calculations. For the patient subgroup that mirrored the population we intended to include in the TIM-HF2 trial, 19 days were lost due to all-cause death or unplanned cardiovascular hospital admissions at 12 months in the usual care group, and 12 days were lost for patients in the remote patient management group, which corresponds to a 38% reduction.10,18 With an estimated pooled SD of 48, we calculated that 750 patients would be required in each group to detect this difference with a power of 80% and a two-sided α of 5%.
Combined telemonitoring and telecoaching for heart failure improves outcome
2023, npj Digital Medicine
- ☆
Trial funding: The technology development as well as the clinical trial was funded in a public–private partnership through a research grant of the German Federal Ministry of Economics and Technology: (01MG531) and by the following companies: Robert-Bosch Healthcare GmbH, Waiblingen, Germany; InterComponentWare AG, Walldorf, Germany and Aipermon GmbH & Co. KG, Munich, Germany associated with the German Network of Competence for Heart Failure.
- ☆☆
(ClinicalTrials.gov number, NCT00543881).
- 1
On behalf of the TIM-HF investigators.
- 2
B-AK and SDA would like to be considered as joint last author.