Evidence map›Paper›PMID 38773662›Full record

ArticleTrials2024

Telemedicine home-based management in patients with chronic heart failure and diabetes type II: study protocol for a randomized controlled trial.

Palmira Bernocchi, Vittorio Giudici, Gabriella Borghi, Patrizia Bertolaia, Salvatore D'Isa, Roberto Trevisan, Simonetta Scalvini

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05633784 (Telemedicine Home-based Management in Patients With Chronic Heart Failure and Type 2 Diabetes), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05633784 nacompletednot on this map

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

TypeinterventionalSponsorIstituti Clinici Scientifici Maugeri SpARan2022 to 2024Enrolled163ConditionsChronic Heart Failure, Diabetes MellitusArmsTeleassistance, Teleconsultation, Telerehabilitation, Telemonitoring, mHealth
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Palmira BernocchiContinuity of Care Service, Istituti Clinici Scientifici Maugeri IRCCS, Institute of Lumezzane, Via G. Mazzini 129, 25065, Lumezzane, Brescia, Italy. palmira.bernocchi@icsmaugeri.it.ORCID http://orcid.org/0000-0003-0875-2007
Vittorio GiudiciDepartment of Cardiac Rehabilitation, Bolognini Hospital, Azienda Socio-Sanitaria Territoriale Bergamo Est, Seriate, Bergamo, Italy.
Gabriella BorghiContinuity of Care Service, Istituti Clinici Scientifici Maugeri IRCCS, Institute of Lumezzane, Via G. Mazzini 129, 25065, Lumezzane, Brescia, Italy.
Patrizia BertolaiaSocio-Health Management Direction, Azienda Socio-Sanitaria Territoriale Bergamo Est, Seriate, Bergamo, Italy.
Salvatore D'IsaCardiovascular Department, Cardiology Unit, ASST Papa Giovanni XXIII, Bergamo, Italy.
Roberto TrevisanEndocrinology and Diabetes Unit, ASST Papa Giovanni XXIII, Bergamo, Italy.
Simonetta ScalviniContinuity of Care Service, Istituti Clinici Scientifici Maugeri IRCCS, Institute of Lumezzane, Via G. Mazzini 129, 25065, Lumezzane, Brescia, Italy.

Funding

Ministero della Salute NET-2018-12367206-3Regione Lombardia NET-2018-12367206-3
6 · The paper itself

Abstract

backgroundHeart failure and type 2 diabetes are prevalent public health issues in Europe. These complex chronic conditions require extensive pharmacological management, ongoing self-care, and behavioral changes. Despite the known benefits of lifestyle changes, such as regular exercise and better control of blood sugar levels, patients may need help implementing the recommended changes. This study aims to assess the effectiveness of a telemedicine program for managing heart failure and type 2 diabetes at home. The program focuses on promoting lifestyle changes. METHODS AND ANALYSIS: During scheduled outpatient cardiology evaluations, eligible patients are recruited and randomly assigned to either an intervention or control group in a 1:1 ratio. The intervention group receives support from a nursing case manager through a structured home-based teleassistance program and a trainer for daily physical activity stimulation. They also have access to teleconsultations with cardiologists and diabetes specialists as needed, telemonitoring of vital signs, and daily step tracking. An app records and monitors daily drug treatment, glycemia, blood pressure, heart rate, and other clinical parameters. Patients can also self-report symptoms and communicate via a chat and videoconference system with a Nurse Case Manager. The control group receives routine care. Data collection occurs before intervention and 6 months after baseline during a new outpatient cardiology evaluation. The primary outcome is to measure the difference in the distance walked during a 6-min walk test between baseline and after 6 months. The key secondary outcomes include improving the disease status and physical activity profile. Data will be analyzed according to the intention-to-treat principles. DISCUSSION: This study will provide evidence on the efficacy of a telemedicine home-based management model to maintain correct lifestyles in patients with both heart failure and type 2 diabetes, improving self-management, their empowerment on the diseases, and increasing their knowledge and ability to recognize symptoms early.

trial registrationClinicalTrials.gov NCT05633784. Registered on November 30, 2022.

Indexed as

Diabetes Mellitus, Type 2Heart FailureRandomized Controlled Trials as TopicTelemedicineChronic DiseaseHome Care ServicesHumansSelf CareTime FactorsTreatment Outcome6-min walk testDiabetes mellitus type IIHeart failureMotivational feedbackRandomized controlled trialTeleassistanceTele-healthTelemedicineTelemonitoringTelerehabilitation

Identifiers

PMID38773662
PMCPMC11106884

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.