Clinical trial NCT05633784: Telemedicine Home-based Management in Patients With CHF and Type 2 Diabetes
Official title: Telemedicine Home-based Management in Patients With Chronic Heart Failure and Type 2 Diabetes: a Randomized Control Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Heart Failure
Diabetes Mellitus
Keywords: telemedicine
case management
mobile technologies (mHealth)
Physical activities
6-min walking test
motivational feedback
Lead sponsor: Istituti Clinici Scientifici Maugeri SpA
Sponsor class: OTHER
Collaborators: name: Azienda Ospedaliera Bolognini di Seriate Bergamo
name: Papa Giovanni XXIII Hospital
First posted: 2022-12-01
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in tolerance capacity
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Change of hospitalizations
timeFrame: 6 months
measure: Number of Steps
timeFrame: Baseline and 6 months
measure: HbA1c dosage
timeFrame: Baseline and 6 months
measure: Change in quality of life related to heart failure
timeFrame: Baseline and 6 months
measure: Change in quality of life related to Diabetes
timeFrame: Baseline and 6 months
measure: Change in quality of life
timeFrame: Baseline and 6 months
measure: Assessment of physical activity.
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Seriate
country: Italy
facility: Azienda Ospedaliera Bolognini di Seriate Bergamo
state: Bergamo
city: Lumezzane
country: Italy
facility: Istituti Clinici Scientifici Maugeri
state: Brescia
city: Bergamo
country: Italy
facility: Papa Giovanni XXIII Hospital
Study officials:
affiliation: ICS MAUGERI
name: SIMONETTA SCALVINI, MD
role: STUDY_CHAIR
References:
citation: Seferovic PM, Petrie MC, Filippatos GS, Anker SD, Rosano G, Bauersachs J, Paulus WJ, Komajda M, Cosentino F, de Boer RA, Farmakis D, Doehner W, Lambrinou E, Lopatin Y, Piepoli MF, Theodorakis MJ, Wiggers H, Lekakis J, Mebazaa A, Mamas MA, Tschope C, Hoes AW, Seferovic JP, Logue J, McDonagh T, Riley JP, Milinkovic I, Polovina M, van Veldhuisen DJ, Lainscak M, Maggioni AP, Ruschitzka F, McMurray JJV. Type 2 diabetes mellitus and heart failure: a position statement from the Heart Failure Association of the European Society of Cardiology. Eur J Heart Fail. 2018 May;20(5):853-872. doi: 10.1002/ejhf.1170. Epub 2018 Mar 8.
citation: Thrainsdottir IS, Aspelund T, Thorgeirsson G, Gudnason V, Hardarson T, Malmberg K, Sigurdsson G, Ryden L. The association between glucose abnormalities and heart failure in the population-based Reykjavik study. Diabetes Care. 2005 Mar;28(3):612-6. doi: 10.2337/diacare.28.3.612.
citation: Sharma A, Mentz RJ, Granger BB, Heitner JF, Cooper LB, Banerjee D, Green CL, Majumdar MD, Eapen Z, Hudson L, Felker GM. Utilizing mobile technologies to improve physical activity and medication adherence in patients with heart failure and diabetes mellitus: Rationale and design of the TARGET-HF-DM Trial. Am Heart J. 2019 May;211:22-33. doi: 10.1016/j.ahj.2019.01.007. Epub 2019 Jan 31.
citation: Scalvini S, Bernocchi P, Zanelli E, Comini L, Vitacca M; Maugeri Centre for Telehealth and Telecare (MCTT). Maugeri Centre for Telehealth and Telecare: A real-life integrated experience in chronic patients. J Telemed Telecare. 2018 Aug;24(7):500-507. doi: 10.1177/1357633X17710827. Epub 2017 May 24.
citation: Bernocchi P, Giudici V, Borghi G, Bertolaia P, D'Isa S, Trevisan R, Scalvini S. Telemedicine home-based management in patients with chronic heart failure and diabetes type II: study protocol for a randomized controlled trial. Trials. 2024 May 21;25(1):333. doi: 10.1186/s13063-024-08171-0.