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Chronic Heart FailureTELEMECHRONNCT05633784

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

A study testing Teleassistance, Teleconsultation and Telerehabilitation in people with Chronic Heart Failure and Diabetes Mellitus, run by Istituti Clinici Scientifici Maugeri SpA at 3 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Heart Failure, Diabetes Mellitus
What is being tested?
Teleassistance, Teleconsultation and Telerehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
163 participants
Where
3 sitesItaly
Study dates
18 Aug 2022to 30 Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

Italy3 sites

  • Papa Giovanni XXIII Hospital

    Bergamo

  • Istituti Clinici Scientifici Maugeri

    Lumezzane, Brescia, 25065

  • Azienda Ospedaliera Bolognini di Seriate Bergamo

    Seriate, Bergamo

Other trials in Italy

About this study

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

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.

Being tested
Teleassistance, Teleconsultation, Telerehabilitation, Telemonitoring, mHealth
Keywords
telemedicine, case management, mobile technologies (mHealth), Physical activities, 6-min walking test, motivational feedback
Medical subject headings
Diabetes Mellitus, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TeleassistanceOther

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

  • TeleconsultationOther

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

  • TelerehabilitationOther

    Support from a physiotherapist (if needed)

  • TelemonitoringOther

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

  • mHealthOther

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

  • telepsycologyOther

    Psychological support (if necessary)

  • Quality of lifeOther

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

  • Biochemistry evaluationOther

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

  • Clinical evaluationOther

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

  • State of health of the patientOther

    Severity Index and Comordbidity index

Study groups in NCT05633784
Study groupRoleWhat they receive
Intervention groupExperimentalAt 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.
Receives: 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 groupActive comparatorAt 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.
Receives: Other: Quality of life; Other: Biochemistry evaluation; Other: Clinical evaluation; Other: State of health of the patient

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in tolerance capacity

    The change from baseline in tolerance capacity will be measured by walking test performance (meters walked).

    Measured: Baseline and 6 months

Secondary outcomes (7)

  1. Change of hospitalizations

    Change of hospitalizations for cardiovascular problems, diabetes and all-causes

    Measured: 6 months

  2. Number of Steps

    The difference in the weekly mean in the number of steps from baseline over the 6 months of follow-up.

    Measured: Baseline and 6 months

  3. HbA1c dosage

    Change of the disease status

    Measured: Baseline and 6 months

  4. Change in quality of life related to heart failure

    Change in quality of life measured by Minnesota Living with Heart Failure (MLHFQ) questionnaire

    Measured: Baseline and 6 months

  5. Change in quality of life related to Diabetes

    Change in quality of life measured by Diabetes quality of life (DQoL) questionnaire

    Measured: Baseline and 6 months

  6. Change in quality of life

    Change in quality of life measured by 12-item Short Form Survey (SF-12) questionnaire

    Measured: Baseline and 6 months

  7. 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.

    Measured: Baseline and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Dec 2022
  2. Study start18 Aug 2022
  3. Primary completion30 Sep 2024
  4. Study completion30 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
163 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05633784
Sponsor's protocol ID
ICS Maugeri CE2338
Other IDs
NET-2018-12367206-WP3
Acronym
TELEMECHRON
Status last verified
Oct 2024
First submitted
17 Nov 2022
Last updated
1 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 29520964

  • 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.

    PubMed 15735197

  • 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.

    PubMed 30831331

  • 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.

    PubMed 28537509

  • 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.

    PubMed 38773662

Questions about this trial

What is this clinical trial studying?

A study testing Teleassistance, Teleconsultation and Telerehabilitation in people with Chronic Heart Failure and Diabetes Mellitus, run by Istituti Clinici Scientifici Maugeri SpA at 3 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in tolerance capacity (time frame: Baseline and 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05633784, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2024.

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