Description of Patient Adherence to Heart Failure Remote Monitoring and Its Determinants (TELE'IC)

December 4, 2024 updated by: Centre Hospitalier Régional Metz-Thionville

This is a monocentric cohort study, with retrospective data collection and prospective semi-structured interviews.

All patients who, since 2020, have received telemonitoring for heart failure after hospitalization at the CHR Metz-Thionville will be included. Patients will be informed of the study by e-mail, or by post if no e-mail is available. Data concerning their socio-demographic and clinical characteristics will be collected from the computerized patient record, and telerecording data will be extracted from the telerecording software.

Patients whose follow-up is still in progress will be monitored (=simple data collection) for 12 months, or until follow-up is terminated if necessary. Patients whose follow-up has been interrupted for less than a month at the start of the study (to avoid memory bias) or during the course of the study will be contacted by telephone by the IPA carrying out the telemonitoring, and offered, after oral consent, a semi-structured interview to investigate the reasons for the interruption.

Study Overview

Status

Recruiting

Conditions

Detailed Description

In 2022, the Caisse Primaire d'Assurance Maladie indicated that 'more than 1.5 million people suffer from heart failure, particularly the over-60s. Heart failure has a major impact on the quality of life of individuals and their families. It is the cause of 200,000 hospitalisations a year. With an ageing population, the incidence of heart failure is set to increase by 25% every four years over the next few years'.

In its WHITE PAPER, the Conseil National Professionnel Cardio Vasculaire recommended the day-to-day use of digital tools to monitor patients in the face of delays in consultations in towns and cities. According to the studies carried out, these 'delays (...) are such that they do not prevent 47.4% of patients from being admitted to hospital more than 15 days after the onset of the first symptoms. For a third of patients, this delay rises to more than 2 months'.

According to Brandon et al, in 2009 remote monitoring of patients with the implementation of call by an ABI reduces CI-related readmissions and this helps to improve patients' quality of life.However, they noted that this required 'further exploration of the role of the API in helping patients with CI achieve desired outcomes.'A 2022 study based on a multicentre randomised controlled trial showed that remote monitoring after hospitalisation improved survival in heart failure patients.

Other chronic pathologies are also monitored remotely, such as inflammatory arthritis.A prospective cohort study of 220 patients conducted by J. WIEGEL, published in 2022, looked at the profile of patients who did or did not adhere to remote monitoring of their condition.It was found that women discontinued this type of treatment more quickly. In conclusion, he wondered about the 'reasons why patients do not adhere to telemonitoring, as well as the reasons why they do'. He concluded by saying that these reasons 'must be studied in order to improve the adaptation of telemonitoring'.

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Heart failure patients

Description

Inclusion Criteria:

  • Major patient
  • Heart failure
  • Having received telemonitoring for heart failure from the CHR
  • Patient clearly informed about the research in progress
  • Gave oral consent for telephone interview

Exclusion Criteria:

  • Refusal to reuse data for the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to break in remote monitoring (survival)
Time Frame: up to four years after start of remote monitoring
Defined as the number of months of remote monitoring performed before interruption - no response from the patient after 6 weeks of reminders at a rate of 2 reminders per week, excluding justified absences. Cancellation of remote monitoring for any other reason will be considered a right censorship
up to four years after start of remote monitoring

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients who break off follow-up at 6 months
Time Frame: 6 months after start of remote monitoring
6 months after start of remote monitoring
Proportion of patients who break off follow-up at 12 months
Time Frame: 12 months after start of remote monitoring
Proportion of patients who break off follow-up
12 months after start of remote monitoring
Proportion of patients who break off follow-up at 24 months
Time Frame: 24 months after start of remote monitoring
Proportion of patients who break off follow-up
24 months after start of remote monitoring
Break-off
Time Frame: up to four years after start of remote monitoring
Mean time to break-off
up to four years after start of remote monitoring

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Régional Metz-Thionville

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2024

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

December 4, 2024

First Submitted That Met QC Criteria

December 4, 2024

First Posted (Estimated)

December 9, 2024

Study Record Updates

Last Update Posted (Estimated)

December 9, 2024

Last Update Submitted That Met QC Criteria

December 4, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-05Obs-CHRMT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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