Description of Patient Adherence to Heart Failure Remote Monitoring and Its Determinants

NCT06723509 | Recruiting

• 1 other identifier: 2024-05Obs-CHRMT
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 2

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.

Conditions

Remote Monitoring; Heart Failure Patients

Keywords

remote monitoring; heart failure patients; adherence

Outcome Measures

Primary Outcomes (1)

• Time to break in remote monitoring (survival)

  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 Outcomes (4)

• Proportion of patients who break off follow-up at 6 months

  6 months after start of remote monitoring

• Proportion of patients who break off follow-up at 12 months

  12 months after start of remote monitoring

• Proportion of patients who break off follow-up at 24 months

  24 months after start of remote monitoring

• Break-off

  up to four years after start of remote monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Heart failure patients

You may qualify if:

• 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

You may not qualify if:

• Refusal to reuse data for the study

Sponsors & Collaborators

• Centre Hospitalier Régional Metz-Thionville: lead

Study Sites (2)

CHR Metz Thionville Hopital de Mercy

Metz, 57085, France

RECRUITING

CHR Metz-Thionville Hopital Bel Air

Thionville, 57100, France

RECRUITING

Central Study Contacts

Arpiné EL NAR, PhD

CONTACT

0033387557766; projet-recherche-clinique@chr-metz-thionville.fr

Céline PETITJEAN

CONTACT

0033387186149; celine.petitjean@chr-metz-thionville.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 9, 2024
• Study Start: July 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)