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

Summary

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.

Conditions

• Chronic Heart Failure
• Diabetes Mellitus

Interventions

OTHER

Teleassistance

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

OTHER

Teleconsultation

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

OTHER

Telerehabilitation

Support from a physiotherapist (if needed)

OTHER

Telemonitoring

Telemonitoring of patient vital signs (eg single electrocardiographic trace) and delay steps

OTHER

mHealth

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

OTHER

telepsycology

Psychological support (if necessary)

OTHER

Quality of life

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

OTHER

Biochemistry evaluation

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

OTHER

Clinical evaluation

6-minute-walking test, IMC, NYHA class, Ejection fraction

OTHER

State of health of the patient

Severity Index and Comordbidity index

Sponsors & Collaborators

• Azienda Ospedaliera Bolognini di Seriate Bergamo

  collaborator OTHER

• Papa Giovanni XXIII Hospital

  collaborator OTHER

• Istituti Clinici Scientifici Maugeri SpA

  lead OTHER

Principal Investigators

• SIMONETTA SCALVINI, MD · ICS MAUGERI

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-08-18

Primary Completion

2024-09-30

Completion

2024-09-30

Countries

• Italy

Study Locations