Telemedicine home-based management in patients with chronic heart failure and diabetes type II: a randomized controlled trial

Abstract

Background: Heart failure and type 2 diabetes are prevalent public health issues in Europe. These complex chronic conditions require extensive pharmacological management, ongoing self‐care, and behavioural changes in lifestyle habits, such as regular exercise and better control of blood sugar levels. Purpose: This study aimed to assess the effectiveness of a telemedicine program for managing patients at home, focusing on promoting lifestyle changes. Methods: During scheduled outpatient cardiology evaluations, eligible patients are recruited and randomly assigned to an Intervention (IG) or Control group (CG). The IG received support from a nurse through a structured home‐based teleassistance program. They also had access to teleconsultations with cardiologists as needed, telemonitoring of vital signs, and daily step tracking. An App records and monitors daily drug treatment, glycemia, blood pressure, heart rate, and other clinical parameters. Patients could also self‐report symptoms and communicate with nurses via a chat and videoconference. The CG received routine care. Data collection occurred before intervention (T0) and six months after baseline (T6) during a new outpatient cardiology visit. The primary outcome was to measure the difference in the distance walked during a 6‐minute walk test (6MWT) between T0 and T6. Results: From August 2022 to March 2024, 163 patients (84% male) were randomized, 82 in the IG and 81 in the CG. Their mean (SD) age was 71(8) years in IG, and 74(8) in CG, p=0.0961. In both groups, 69% of patients were in NYHA class II and 30% in NYHA class III. The mean(SD) of glycated haemoglobin at T0 was 57.4(20.8) mmol/L in CG and 52.2(15.8) mmol/L in IG (p=53208) and NTproBNP was 1362(1657)pg/mL in CG and 999(1238) pg/mL in IG, respectively (p=0.051). The body max index at T0 was 28.4(7.8) in CG and 28.3(5.0) in IG (p=0.4724). After 6 months, the IG were able to walk further than at baseline: Mean (95% CI) Δ6MWT was 11.76 [0.78, 22.74] metres compared to CG that showed a Δ6MWT decrease of ‐20.68 [‐33.01, ‐8.35] metres: P<0.0000 between groups. In the CG, 71% of patients had worsened their exercise tolerance compared to the intervention group, where 41% of patients had improved. The PASE, which consists of self‐reported occupational, household and recreational items over 1 week, in the CG [mean (95% CI)] decreased significantly over the 6 months [from T0: 96.16 ( 84.44, 107.88) to T6 81.14 (68.81, 93.47); p=0.0212] while it increased, although not significantly, in the IG [from T0: 102.52 (90.29, 114.74) to T6 108.98 (94.76, 123.19); p=0.2914]. The difference between groups was significant (p=0.0190). Conclusions: This study provided evidence on the efficacy of a telemedicine home‐based management model to maintain correct lifestyles in patients with both heart failure and Type 2 diabetes, improving self‐management, their empowerment on the diseases, and increasing their knowledge and ability to recognize symptoms early. (Figure Presented).