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

October 30, 2024 updated by: Istituti Clinici Scientifici Maugeri SpA

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

163

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bergamo, Italy
        • Papa Giovanni XXIII Hospital
    • Bergamo
      • Seriate, Bergamo, Italy
        • Azienda Ospedaliera Bolognini di Seriate Bergamo
    • Brescia
      • Lumezzane, Brescia, Italy, 25065
        • Istituti Clinici Scientifici Maugeri

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
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.
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
Active Comparator: Control group
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in tolerance capacity
Time Frame: Baseline and 6 months
The change from baseline in tolerance capacity will be measured by walking test performance (meters walked).
Baseline and 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituti Clinici Scientifici Maugeri SpA

Collaborators

Azienda Ospedaliera Bolognini di Seriate Bergamo
Papa Giovanni XXIII Hospital

Investigators

  • Study Chair: SIMONETTA SCALVINI, MD, ICS Maugeri

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 18, 2022

Primary Completion (Actual)

September 30, 2024

Study Completion (Actual)

September 30, 2024

Study Registration Dates

First Submitted

November 17, 2022

First Submitted That Met QC Criteria

November 30, 2022

First Posted (Actual)

December 1, 2022

Study Record Updates

Last Update Posted (Estimated)

November 1, 2024

Last Update Submitted That Met QC Criteria

October 30, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICS Maugeri CE2338
  • NET-2018-12367206-WP3 (Other Identifier: Italian Ministry of Health)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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