Background: Telemonitoring for heart failure (HF) captures patient data such as body weight, blood pressure, heart rate, and subjective well-being via mobile applications or standalone devices to complement nurse-led disease management programmes (DMPs). In Austria, DMPs for HF patients are already in use, with telemonitoring implemented differently across regions. The expected benefits include prevention of rehospitalisation, reduction of mortality, and cost savings. The aim of this work was to systematically assess the efficacy and safety of non-invasive telemonitoring in addition to DMPs compared to DMPs without telemonitoring in HF patients post-hospital discharge. A further aim was to develop an evaluation concept for the systematic assessment of clinical and organisational effects of digital health technologies in Austrian DMPs.

Methods: A systematic literature search was conducted in four databases (Medline, Embase, The Cochrane Library, HTA database) and supplemented by hand search (1,351 hits). Randomised controlled trials (RCTs) from 2010 onwards comparing non-invasive telemonitoring in addition to DMPs with DMPs without telemonitoring in HF patients post-hospital discharge were included. Internal validity was assessed using the Cochrane Risk of Bias Tool v2, and certainty of evidence using the GRADE schema.

Results: Three RCTs (2007–2015) with a total of 527 patients (approximately 189 HF patients in telemonitoring + DMP groups) were identified. The certainty of evidence was predominantly moderate, primarily due to wide confidence intervals and small sample sizes. The primary endpoints of the studies were rehospitalisation (2 studies) and health-related quality of life (1 study). Regarding efficacy, one study showed a statistically significant reduction in HF-related rehospitalisation in favour of the intervention. One study used the Minnesota Living with Heart Failure Questionnaire (MLWHFQ) and reported a statistically significant improvement in the telemonitoring + DMP group. No significant differences were found for all-cause mortality, all-cause rehospitalisation, and hospital length of stay. Compliance was reported in one study at 70%. No data on adverse events were reported. For Austrian digital health technologies in DMPs, an evaluation concept was developed based on the studies and the ASSESS-DHT manual for the systematic assessment of clinical, organisational, and economic care effects. As it is a Class IIb medical device and the added clinical benefit has not yet been sufficiently demonstrated by controlled studies, controlled trials (e.g., cluster RCT, stepped-wedge design, target trial emulation) with endpoints of HF-related mortality and quality of life are recommended.

Conclusion: The available evidence has limitations, particularly lack of statistical precision, small sample sizes, and wide confidence intervals. Cost-effectiveness data are lacking. A comprehensive cost-effectiveness analysis from the Austrian payer perspective is recommended.