NCT05633784Completed
Telemedicine Home-based Management in Patients With CHF and Type 2 Diabetes
Telemedicine Home-based Management in Patients With Chronic Heart Failure and Type 2 Diabetes: a Randomized Control Study
Source: ClinicalTrials.gov · Last updated 1 Nov 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 163 (actual)
- First submitted
- 17 Nov 2022
- Start date
- 18 Aug 2022
- Primary completion date
- 30 Sept 2024
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Diseases
- Heart failure, Type 2 diabetes
- NCT number
- NCT05633784
What you commit to
- Study type: Interventional
- Participants enrolled: 163
- From 18 Aug 2022 to the primary completion date, 30 Sept 2024
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Papa Giovanni XXIII Hospital Coordinator of this site? Confirm its status | Bergamo | Italy | Unknown status |
| Istituti Clinici Scientifici Maugeri Coordinator of this site? Confirm its status | Lumezzane | Italy | Unknown status |
| Azienda Ospedaliera Bolognini di Seriate Bergamo Coordinator of this site? Confirm its status | Seriate | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.