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

Not Applicable

Completed

• Conditions: Chronic Heart Failure; Diabetes Mellitus
• Interventions: Other: Teleassistance; Other: Quality of life; Other: Biochemistry evaluation; Other: Teleconsultation; Other: Telerehabilitation; Other: Telemonitoring; Other: mHealth; Other: telepsycology; Other: Clinical evaluation; Other: State of health of the patient

• Registration Number: NCT05633784
• Lead Sponsor: Istituti Clinici Scientifici Maugeri SpA

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-18
• Study First Submitted: 2022-11-17
• Study First Submitted QC: 2022-11-30
• Study First Posted: 2022-12-01
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-30
• Last Update Posted: 2024-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 163

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Teleassistance	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.
Intervention group	mHealth	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.
Intervention group	State of health of the patient	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.
Control group	Biochemistry evaluation	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.
Intervention group	Teleconsultation	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.
Intervention group	telepsycology	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.
Control group	State of health of the patient	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.
Intervention group	Telerehabilitation	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.
Intervention group	Biochemistry evaluation	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.
Intervention group	Clinical evaluation	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.
Control group	Quality of life	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.
Intervention group	Telemonitoring	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.
Intervention group	Quality of life	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.
Control group	Clinical evaluation	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.

Primary Outcome Measures

Name	Time	Method
Change in tolerance capacity	Baseline and 6 months	The change from baseline in tolerance capacity will be measured by walking test performance (meters walked).

Secondary Outcome Measures

Name	Time	Method
Change of hospitalizations	6 months	Change of hospitalizations for cardiovascular problems, diabetes and all-causes
Number of Steps	Baseline and 6 months	The difference in the weekly mean in the number of steps from baseline over the 6 months of follow-up.
Change in quality of life related to Diabetes	Baseline and 6 months	Change in quality of life measured by Diabetes quality of life (DQoL) questionnaire
Change in quality of life	Baseline and 6 months	Change in quality of life measured by 12-item Short Form Survey (SF-12) questionnaire
Assessment of physical activity.	Baseline and 6 months	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.
Change in quality of life related to heart failure	Baseline and 6 months	Change in quality of life measured by Minnesota Living with Heart Failure (MLHFQ) questionnaire
HbA1c dosage	Baseline and 6 months	Change of the disease status

Trial Locations

Locations (3)

Azienda Ospedaliera Bolognini di Seriate Bergamo; 🇮🇹 Seriate, Bergamo, Italy

Istituti Clinici Scientifici Maugeri; 🇮🇹 Lumezzane, Brescia, Italy

Papa Giovanni XXIII Hospital; 🇮🇹 Bergamo, Italy