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

Istituti Clinici Scientifici Maugeri SpA

Status: Completed

Conditions: Chronic Heart Failure; Diabetes Mellitus

Treatments: Other: Clinical evaluation; Other: Teleassistance; Other: State of health of the patient; Other: mHealth; Other: Biochemistry evaluation; Other: telepsycology; Other: Telerehabilitation; Other: Teleconsultation; Other: Quality of life; Other: Telemonitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT05633784

ICS Maugeri CE2338

NET-2018-12367206-WP3 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 163 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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163 participants in 2 patient groups

Intervention group

Experimental group

Description:

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.

Treatment:

Other: Telemonitoring

Other: Quality of life

Other: Telerehabilitation

Other: Teleconsultation

Other: Biochemistry evaluation

Other: telepsycology

Other: mHealth

Other: State of health of the patient

Other: Clinical evaluation

Other: Teleassistance

Control group

Active Comparator group

Description:

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.

Treatment:

Other: Quality of life

Other: Biochemistry evaluation

Other: State of health of the patient

Other: Clinical evaluation