Clinical trial NCT06723509: Description of Patient Adherence to Heart Failure Remote Monitoring and Its Determinants
Official title: Description of Patient Adherence to Heart Failure Remote Monitoring and Its Determinants
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Remote Monitoring
Heart Failure Patients
Keywords: remote monitoring
heart failure patients
adherence
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2024-12-09
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Heart failure patients

Brief summary: 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.

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'.

Eligibility criteria: 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

Primary outcomes:
measure: Time to break in remote monitoring (survival)
timeFrame: up to four years after start of remote monitoring
Secondary outcomes:
measure: Proportion of patients who break off follow-up at 6 months
timeFrame: 6 months after start of remote monitoring
measure: Proportion of patients who break off follow-up at 12 months
timeFrame: 12 months after start of remote monitoring
measure: Proportion of patients who break off follow-up at 24 months
timeFrame: 24 months after start of remote monitoring
measure: Break-off
timeFrame: up to four years after start of remote monitoring
Other outcomes:
Locations:
city: Metz
country: France
facility: CHR Metz Thionville Hopital de Mercy
city: Thionville
country: France
facility: CHR Metz-Thionville Hopital Bel Air
Study officials:
References: