Skip to main content
OpenTrials
Completed

NCT Number: NCT05633784

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Azienda Ospedaliera Bolognini di Seriate Bergamo, Seriate, Bergamo, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Teleassistance

Other

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

Teleconsultation

Other

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

telerehabilitation

Other

Support from a physiotherapist (if needed)

Telemonitoring

Other

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

mHealth

Other

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

telepsycology

Other

Psychological support (if necessary)

Quality of life

Other

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

Biochemistry evaluation

Other

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

Clinical evaluation

Other

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

State of health of the patient

Other

Severity Index and Comordbidity index

Primary outcomes

  1. 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).

Secondary outcomes

  1. Change of hospitalizations

    Time frame: 6 months

    Change of hospitalizations for cardiovascular problems, diabetes and all-causes

  2. 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.

  3. HbA1c dosage

    Time frame: Baseline and 6 months

    Change of the disease status

  4. 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

  5. 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

  6. 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

  7. 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.

Sponsors and collaborators

Lead sponsor

Istituti Clinici Scientifici Maugeri SpA

Other

Collaborators

  • Azienda Ospedaliera Bolognini di Seriate Bergamo
  • Papa Giovanni XXIII Hospital

Registry information

Official study title

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

Acronym: TELEMECHRON

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 1, 2022
Registry last updated
Nov 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.