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

Diabetes Mellitus Clinical Trial

— TELEMECHRON  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05633784
• Other study ID #: ICS Maugeri CE2338
• Secondary ID: NET-2018-1236720
• Status: Recruiting
• Phase: N/A
• Start date: August 18, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: September 2023
• Source: Istituti Clinici Scientifici Maugeri SpA
• Contact: Palmira Bernocchi, PhD
• Phone: +390308253
• Email: palmira.bernocchi[@]icsmaugeri.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: September 30, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Heart Failure
• Diabetes Mellitus
• Heart Failure

Intervention

Other:
• Teleassistance
Support the nursing case manager through a structured teleconsultation program (telephone and videoconference support at least once a week)
• Teleconsultation
Cardiological and Diabetological teleconsultation at the beginning of the program and in case of need during the program.
• Telerehabilitation
Support from a physiotherapist (if needed)
• Telemonitoring
Telemonitoring of patient vital signs (eg single electrocardiographic trace) and delay steps
• mHealth
The support of an App for recording and monitoring parameters: delay treatment, clinical parameters such as glycemia, blood pressure, HR, symptoms, etc.
• telepsycology
Psychological support (if necessary)
• Quality of life
Minnesota LIVING WITH HEART FAILURE® Questionnaire (MLHFQ), Short Form Survey (SF-12) Questionnaire and Diabetes Quality of Life (DQoL) questionnaire
• Biochemistry evaluation
Glycemia, glycated haemoglobin, total cholesterol, HDL and LDL, triglycerides, creatinine, BUN, creatinine clearance, BNP
• Clinical evaluation
6-minute-walking test, IMC, NYHA class, Ejection fraction
• State of health of the patient
Severity Index and Comordbidity index

Locations

Country	Name	City	State
Italy	Papa Giovanni XXIII Hospital	Bergamo
Italy	Istituti Clinici Scientifici Maugeri	Lumezzane	Brescia
Italy	Azienda Ospedaliera Bolognini di Seriate Bergamo	Seriate	Bergamo

Sponsors (3)

Lead Sponsor	Collaborator
Istituti Clinici Scientifici Maugeri SpA	Azienda Ospedaliera Bolognini di Seriate Bergamo, Papa Giovanni XXIII Hospital

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in tolerance capacity	The change from baseline in tolerance capacity will be measured by walking test performance (meters walked).	Baseline and 6 months
Secondary	Change of hospitalizations	Change of hospitalizations for cardiovascular problems, diabetes and all-causes	6 months
Secondary	Number of Steps	The difference in the weekly mean in the number of steps from baseline over the 6 months of follow-up.	Baseline and 6 months
Secondary	HbA1c dosage	Change of the disease status	Baseline and 6 months
Secondary	Change in quality of life related to heart failure	Change in quality of life measured by Minnesota Living with Heart Failure (MLHFQ) questionnaire	Baseline and 6 months
Secondary	Change in quality of life related to Diabetes	Change in quality of life measured by Diabetes quality of life (DQoL) questionnaire	Baseline and 6 months
Secondary	Change in quality of life	Change in quality of life measured by 12-item Short Form Survey (SF-12) questionnaire	Baseline and 6 months
Secondary	Assessment of physical activity.	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.	Baseline and 6 months