Telemedicine Home-based Management in Patients With CHF and Type 2 Diabetes (TELEMECHRON)

Telemedicine Home-based Management in Patients With Chronic Heart Failure and Type 2 Diabetes: a Randomized Control Study

The progressive ageing of the population of industrialized countries is accompanied by a dramatic increase in the prevalence of chronic multi-pathologies. In the general population, HF is associated with a higher prevalence of T2DM compared with patients without HF and with marked regional differences observed in Europe and the rest of the world. In clinical trials of chronic HF patients, the prevalence of T2DM is approximately 30% in patients with reduced or preserved ejection fraction and rises to as much as 45% in hospitalized patient registries. A complex drug regimen is often associated with low adherence in patients with HF and T2DM and poor adherence is associated with adverse clinical events. Similarly, adherence to recommendations regarding lifestyle changes, such as increasing physical activity, is often limited despite these changes' favourable effects on the patient. Therefore, interventions are needed to improve all these factors and optimize adherence. The inclusion of telemedicine (telenursing, telerehabilitation, mHealth) focused on health and correct behaviour can create opportunities to implement customized and scalable solutions in populations at risk. The project will aim to evaluate for patients with chronic diseases with a complex phenotype (heart failure and type II diabetes mellitus) the effectiveness of a remote surveillance program with particular attention to lifestyle changes.

telemedicine, case management, mobile technologies (mHealth), Physical activities, 6-min walking test, motivational feedback

Consenting eligible patients were randomized to either an Intervention or a Control group (1:1). A computer (www.randomization.com) generated tables to allocate patients in fixed blocks of four. In order to prevent selection bias, the list of randomization will be managed by personnel not directly involved in the enrolment of the patient. Due to the nature of the intervention, neither the patients nor the physicians were blinded to patients' group allocation. However, outcome assessors and data analysts will be blinded to the allocation.

At the beginning and at the end of the 6-month study period, patients of the Intervention group will perform outpatient cardiological visits. During the 6-month they will be followed through a home remote teleassistance program, designed to provide multidisciplinary support.

At the beginning and at the end of the 6-month study period, patients of the Control group will perform outpatient cardiological visits. During the 6-month at home, patients will be followed in the usual care model by GP.

Support the nursing case manager through a structured teleconsultation program (telephone and videoconference support at least once a week)

Cardiological and Diabetological teleconsultation at the beginning of the program and in case of need during the program.

The support of an App for recording and monitoring parameters: delay treatment, clinical parameters such as glycemia, blood pressure, HR, symptoms, etc.

Minnesota LIVING WITH HEART FAILURE® Questionnaire (MLHFQ), Short Form Survey (SF-12) Questionnaire and Diabetes Quality of Life (DQoL) questionnaire

Glycemia, glycated haemoglobin, total cholesterol, HDL and LDL, triglycerides, creatinine, BUN, creatinine clearance, BNP

The change from baseline in tolerance capacity will be measured by walking test performance (meters walked).

The difference in the weekly mean in the number of steps from baseline over the 6 months of follow-up.

Change in physical activity profile by Physical Activity Scale for the Elderly (PASE). The total PASE score is computed by multiplying the amount of time spent on each activity (hours/week) or participation (yes/no) in an activity by the empirically derived item weights and summing overall activities.

Inclusion Criteria: Inform consent Age ≥ 18 years Documented diagnosis of heart failure, NYHA class II-III (reduced or preserved Ejection fraction without hospitalization in the last 3 months Diagnosis of Diabetes Mellitus Type II in pharmacological treatment from at least one month Ability to walk without assistive devices Consent to using a device (independently or with the support of a caregiver) for recording the single electrocardiographic trace at home Consent to using the App Exclusion Criteria: Subjects with poor collaboration No possibility of using mobile technology Life expectancy of fewer than 6 months Medical issues that preclude participation in the program

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