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Clinical Trials/NCT05633784
NCT05633784
Completed
N/A

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

Istituti Clinici Scientifici Maugeri SpA3 sites in 1 country163 target enrollmentAugust 18, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Chronic Heart Failure
Sponsor
Istituti Clinici Scientifici Maugeri SpA
Enrollment
163
Locations
3
Primary Endpoint
Change in tolerance capacity
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 18, 2022
End Date
September 30, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • Change of hospitalizations(6 months)
  • Number of Steps(Baseline and 6 months)
  • HbA1c dosage(Baseline and 6 months)
  • Change in quality of life related to Diabetes(Baseline and 6 months)
  • Change in quality of life(Baseline and 6 months)
  • Assessment of physical activity.(Baseline and 6 months)
  • Change in quality of life related to heart failure(Baseline and 6 months)

Study Sites (3)

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