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

NCT05633784 | Completed

• 2 other identifiers: ICS Maugeri CE2338NET-2018-12367206-WP3
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 3

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.

Conditions

Chronic Heart Failure; Diabetes Mellitus

Keywords

telemedicine; case management; mobile technologies (mHealth); Physical activities; 6-min walking test; motivational feedback

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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 heart failure

  Baseline and 6 months

• Change in quality of life related to Diabetes

  Baseline and 6 months

Study Arms (2)

Intervention group

EXPERIMENTAL

At the beginning and at the end of the 6-month study period, patients of the Intervention group will perform outpatient cardiological visits. During the 6-month they will be followed through a home remote teleassistance program, designed to provide multidisciplinary support.

Other: Teleassistance; Other: Teleconsultation; Other: Telerehabilitation; Other: Telemonitoring; Other: mHealth; Other: telepsycology; Other: Quality of life; Other: Biochemistry evaluation; Other: Clinical evaluation; Other: State of health of the patient

Control group

ACTIVE COMPARATOR

At the beginning and at the end of the 6-month study period, patients of the Control group will perform outpatient cardiological visits. During the 6-month at home, patients will be followed in the usual care model by GP.

Other: Quality of life; Other: Biochemistry evaluation; Other: Clinical evaluation; Other: State of health of the patient

Interventions

Teleassistance OTHER

Support the nursing case manager through a structured teleconsultation program (telephone and videoconference support at least once a week)

Intervention group

Teleconsultation OTHER

Cardiological and Diabetological teleconsultation at the beginning of the program and in case of need during the program.

Intervention group

Telerehabilitation OTHER

Support from a physiotherapist (if needed)

Intervention group

Telemonitoring OTHER

Telemonitoring of patient vital signs (eg single electrocardiographic trace) and delay steps

Intervention group

mHealth OTHER

The support of an App for recording and monitoring parameters: delay treatment, clinical parameters such as glycemia, blood pressure, HR, symptoms, etc.

Intervention group

telepsycology OTHER

Psychological support (if necessary)

Intervention group

Quality of life OTHER

Minnesota LIVING WITH HEART FAILURE® Questionnaire (MLHFQ), Short Form Survey (SF-12) Questionnaire and Diabetes Quality of Life (DQoL) questionnaire

Control group; Intervention group

Biochemistry evaluation OTHER

Glycemia, glycated haemoglobin, total cholesterol, HDL and LDL, triglycerides, creatinine, BUN, creatinine clearance, BNP

Control group; Intervention group

Clinical evaluation OTHER

6-minute-walking test, IMC, NYHA class, Ejection fraction

Control group; Intervention group

State of health of the patient OTHER

Severity Index and Comordbidity index

Control group; Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead
• Azienda Ospedaliera Bolognini di Seriate Bergamo: collaborator
• Papa Giovanni XXIII Hospital: collaborator

Study Sites (3)

Azienda Ospedaliera Bolognini di Seriate Bergamo

Seriate, Bergamo, Italy

Location

Istituti Clinici Scientifici Maugeri

Lumezzane, Brescia, 25065, Italy

Location

Papa Giovanni XXIII Hospital

Bergamo, Italy

Location

Related Publications (5)

• 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.

  PMID: 29520964 BACKGROUND

• 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.

  PMID: 15735197 BACKGROUND

• 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.

  PMID: 30831331 BACKGROUND

• 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.

  PMID: 28537509 BACKGROUND

• 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.

  PMID: 38773662 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus; Motor Activity

Interventions

Remote Consultation; Telerehabilitation; Telemedicine; Quality of Life

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Referral and Consultation; Professional Practice; Organization and Administration; Health Services Administration; Delivery of Health Care; Patient Care Management; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• SIMONETTA SCALVINI, MD

  ICS MAUGERI

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Consenting eligible patients were randomized to either an Intervention or a Control group (1:1). A computer (www.randomization.com) generated tables to allocate patients in fixed blocks of four. In order to prevent selection bias, the list of randomization will be managed by personnel not directly involved in the enrolment of the patient. Due to the nature of the intervention, neither the patients nor the physicians were blinded to patients' group allocation. However, outcome assessors and data analysts will be blinded to the allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2022
• First Posted: December 1, 2022
• Study Start: August 18, 2022
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: November 1, 2024

Record last verified: 2024-10

Locations

IT (3)