Telemedicine Home-based Management in Patients With CHF and Type 2 Diabetes
NCT ID: NCT05633784
Last Updated: 2024-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
163 participants
INTERVENTIONAL
2022-08-18
2024-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
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.
Study Groups
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Intervention group
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.
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
Control group
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.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* No possibility of using mobile technology
* Life expectancy of fewer than 6 months
* Medical issues that preclude participation in the program
18 Years
ALL
No
Sponsors
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Azienda Ospedaliera Bolognini di Seriate Bergamo
OTHER
Papa Giovanni XXIII Hospital
OTHER
Istituti Clinici Scientifici Maugeri SpA
OTHER
Responsible Party
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Principal Investigators
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SIMONETTA SCALVINI, MD
Role: STUDY_CHAIR
ICS MAUGERI
Locations
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Azienda Ospedaliera Bolognini di Seriate Bergamo
Seriate, Bergamo, Italy
Istituti Clinici Scientifici Maugeri
Lumezzane, Brescia, Italy
Papa Giovanni XXIII Hospital
Bergamo, , Italy
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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NET-2018-12367206-WP3
Identifier Type: OTHER
Identifier Source: secondary_id
ICS Maugeri CE2338
Identifier Type: -
Identifier Source: org_study_id
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