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Recruiting
NCT05633784
Telemedicine Home-based Management in Patients With CHF and Type 2 Diabetes
Conditions: Chronic Heart Failure, Diabetes Mellitus
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 240
Sponsor: Istituti Clinici Scientifici Maugeri SpA
Location: Italy
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.
Eligibility Criteria
Inclusion Criteria:Inform consentAge ≥ 18 yearsDocumented diagnosis of heart failure, NYHA class II-III (reduced or preserved Ejection fraction without hospitalization in the last 3 monthsDiagnosis of Diabetes Mellitus Type II in pharmacological treatment from at least one monthAbility to walk without assistive devicesConsent to using a device (independently or with the support of a caregiver) for recording the single electrocardiographic trace at homeConsent to using the AppExclusion Criteria:Subjects with poor collaborationNo possibility of using mobile technologyLife expectancy of fewer than 6 monthsMedical issues that preclude participation in the program
Source: ClinicalTrials.gov (NCT05633784). StuddyBuddy aggregates publicly available trial information.