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                                          • Telecardiology for heart failure patients: Benefit assessment and evaluation concept for telemedicine-supported care programs in Austria

                                          Telecardiology for heart failure patients: Benefit assessment and evaluation concept for telemedicine-supported care programs in Austria

                                          Adobestock-281945725-von-feodora1
                                          Research areas: High tech medicine, Health economics

                                          Project team: Michaela Riegelnegg

                                          & Michal Stanak
                                          Project lead: Michal Stanak
                                          Duration: April – November 2025
                                          Language: English (with German summary)

                                          Background:
                                          Cardiovascular diseases (CVDs) are one of the leading causes of premature death worldwide [1]. The WHO 2024 report states that in the European region alone, more than 40% of all deaths were due to CVDs [1]. Heart failure (HF) constitutes a subset of this group and is the most common cause of hospitalisation in patients over 65 years of age [2]. HF is a chronic disease characterized by reduced capacity of the heart to pump enough blood and oxygen to supply the organs of the body. This can be associated with deterioration of physical performance [3].

                                          Various approaches have been developed for the treatment of heart failure. In addition to usual care (outpatient visits or hospitalisation), integrated care approaches are becoming established for HF patients through disease management programs (DMPs), which coordinate fragmented care after hospital discharge [4]. These programs aim to improve survival rates, reduce hospital readmissions, and improve quality of life [5]. DMPs are increasingly being supplemented by telemedicine (invasive or non-invasive, e.g., via an app). Due to the complexity and heterogeneity of such additional telemedical interventions, European projects such as the ASSESS-DHT are working on methods to facilitate the assessment of added value of such care programs [6].

                                          As an addition to DMPs, patients with HF can be monitored at distance via the means of telemedicine, i.e. through the use of information and communication technologies. Telemedicine is not a standalone discipline, but it encompasses a variety of digital working methods used within a discipline, in this case cardiology [7]. Telemedicine covers a range of interventions from simple ones, such as s telephone call, to more complex ones, such as an app that may or may not be connected with other stand-alone technologies. An example of a comprehensive telemedical program is HerzMobil Tirol, which uses, among other things, a mobile app for daily documentation and transfer of information such as blood pressure, heart rate, weight, well-being, and drug intake [4]. Based on this information, early signs of deterioration may be detected, relevant therapy adjustments may be considered more quickly, and adherence to medication may be better monitored, thus preventing additional complications and potential hospital readmissions [8].

                                          In Austria, the situation regarding the care of HF patients is currently inconsistent. While selected federal states already have DMPs for HF patients, a nationally uniform care model for HF patients does not exist and is still under development [9]. Some of these federal state-specific DMPs already include telemedical components, while others consist of a series of individual home visits by trained medical professionals without telemedical care components [10]. The actual effects of telemedical care in addition to DMPs on clinical and organisational outcomes remain unclear and will therefore be investigated in this project.

                                          Project goals:
                                          The project aims to:

                                          • systematically assess the evidence on clinical care effects (effectiveness and safety) and organizational care effects (utilization) of an additional non-invasive telemedical component to DMPs/integrated care/structured care models for HF patients compared to DMPs without a telemedical component, or, in case of the absence of evidence,
                                            • assess the clinical and organizational care effects of telemedicine with DMPs compared to standard care, and
                                          • develop an evaluation concept for the assessment of added benefit of digital health technologies as part of DMPs, and
                                          • investigate the practical applicability of the ASSESS-DHT manual for the assessment of digital health technologies.

                                          Non-objectives:
                                          The project does not aim to:

                                          • systematically assess the added benefit of DMPs without telemedicine (e.g. only home visits) and
                                          • systematically assess the cost-effectiveness of the telemedical component in DMPs.

                                          Research questions:
                                          The following research questions (RQ) will be answered in the course of the report:

                                          RQ1: What evidence is available for the clinical and organizational care effects of a non-invasive telemedical component to DMPs/integrated care or structured care models for patients with heart failure compared to DMPs/integrated care or structured care models without this component?

                                          If no evidence is available to answer the question above, the following question with be assessed: What clinical and organizational care effects does telemedicine demonstrate in combination with DMPs/integrated care or structured care models compared to standard care?

                                          RQ2: How can the clinical and organizational care effects of digital health technologies in DMPs be assessed?

                                          Methods: Systematic review of literature for non-invasive telemedical components to DMPs for HF patients using the EUnetHTA Core Model 3.0 or ASSESS DHT manual.

                                          RQ1: systematic review of literature

                                          • conduct a systematic search to identify available literature on non-invasive telemedical components to DMPs for HF patients,
                                          • document the identified publications in a table,
                                          • extract the predefined data from the publications or systematic reviews, and
                                          • synthesise the findings.

                                          RQ2: development of an evaluation concept based on RQ1

                                          • analyse previously conducted studies (e.g., which study designs have been used internationally to evaluate comparable interventions),
                                          • compare with the ASSESS-DHT manual (e.g., what evidence should be available, how should it be collected, which study designs should be used)
                                          • document the results in narrative form.

                                          Inclusion criteria:

                                           

                                          Inclusion

                                          Exclusion

                                          Population

                                          HF patients after hospitalisation

                                          -

                                          Intervention

                                          Non-invasive telemedical intervention in addition to DMPs

                                          Telemedical interventions not combined with DMPs

                                          Comparison

                                          DMPs without a telemedical component/ if there is not evidence: Standard care

                                          -

                                          Outcome

                                          • All cause mortality and HF mortality,
                                          • All cause hospitalization and HF hospitalization,
                                          • Length of stay
                                          • Quality of life,
                                          • Adherence,
                                          • Utilization,
                                          • Benefits for healthcare professionals,
                                          • Quality of collaboration between professional groups (physicians, nurses, etc.)

                                          -

                                          Language

                                          English, German

                                          Other languages

                                          Publication Type

                                          RQ1: Prospective randomised controlled trials, Systematic reviews, HTA reports, all from 2010 onwards

                                          RQ2: no limitation

                                          -

                                          All steps including study selection, data extraction are performed by two researchers. The results will be reviewed by an AIHTA reviewer (internal review) and at least one external peer reviewer.

                                          Timetable and milestones:

                                          Period

                                          Tasks

                                          April 2025

                                          Scoping and finalising the project protocol.

                                          May 2025

                                          -

                                          June-July 2025

                                          Identifying literature for application areas: systematic literature search and hand search. Data extraction.

                                          August – September 2025

                                          Development of an evaluation concept, drafting the report

                                          October 2025

                                          Internal and external  review

                                          November 2025

                                          Layout and publication

                                          References:
                                          Referenzen:
                                          [1] WHO. (2024). Cardiovascular diseases. Zugriff am 22.4.2025. Verfügbar unter https://www.who.int/europe/news-room/fact-sheets/item/cardiovascular-diseases
                                          [2] Benjamin EJ et al (2017) Heart disease and stroke statistics-2017 update: a report from the American Heart Association. Circulation 135:e146–e603
                                          [3] CDC. (2024, 15.05.2024). About Heart Failure. Zugriff am 22.4.2025. Verfügbar unter https://www.cdc.gov/heart-disease/about/heart-failure.html
                                          [4] Ammenwerth E, Modre-Osprian R, Fetz B, Gstrein S, Krestan S, Dörler J, Kastner P, Welte S, Rissbacher C, Pölzl G HerzMobil, an Integrated and Collaborative Telemonitoring-Based Disease Management Program for Patients With Heart Failure: A Feasibility Study Paving the Way to Routine Care JMIR Cardio 2018;2(1):e11 doi: 10.2196/cardio.9936.
                                          [5] ASSESS DHT. Development & harmonisation of methodologies for assessing digital health technologies in Europe. 2024 [cited 21.10.2024]. Available from: https://assess-dht.eu/.
                                          [6] Egelseer-Bruendl, T., Jahn, B., Arvandi, M. et al. Cost-effectiveness of a multidimensional post-discharge disease management program for heart failure patients—economic evaluation along a one-year observation period. Clin Res Cardiol 113, 1232–1241 (2024). https://doi.org/10.1007/s00392-024-02395-5.
                                          [7] Köhler F., Köhler M., Spethmann S. Telemedizin in der Kardiologie. SpringerMedizin. N.D. [cited 05.05.2025]. Available from: https://www.springermedizin.de/emedpedia/detail/klinische-kardiologie/telemedizin-in-der-kardiologie?epediaDoi=10.1007%2F978-3-662-62939-0_44
                                          [8] Lellamo, F., Sposato, B., & Volterrani, M. (2020). Telemonitoring for the management of patients with heart failure. Cardiac Failure Review, 6, e07. doi:https://doi.org/10.15420/cfr.2019.20.
                                          [9] Zielsteuerungsvertrag 2024 bis 2028, Zugriff am 30.4.2025, https://www.sozialministerium.gv.at/Themen/Gesundheit/Gesundheitssystem/Gesundheitsreform-(Zielsteuerung-Gesundheit)/Zielsteuerungsvertrag-2024-bis-2028.html
                                          [10] Poelzl G, Egelseer-Bruendl T, Pfeifer B, Modre-Osprian R, Welte S, Fetz B, Krestan S, Haselwanter B, Zaruba MM, Doerler J, Rissbacher C, Ammenwerth E, Bauer A. Feasibility and effectiveness of a multidimensional post-discharge disease management programme for heart failure patients in clinical practice: the HerzMobil Tirol programme. Clin Res Cardiol. 2022 Mar;111(3):294-307. doi: 10.1007/s00392-021-01912-0. Epub 2021 Jul 16. PMID: 34269863

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