Medical Monitoring of Older Adults Patients After Discharged From Heart Failure Hospitalization

NCT06018532 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-08-30

No results posted yet for this study

Summary

Introduction: PRESAGE CARE has developed a solution for early detection of the risk of emergency department visits and unscheduled hospitalizations. This smartphone-based solution is used by homecare workers and family caregivers to predict the risk of emergency department visits and unscheduled hospitalization within one to two weeks.

Objective: To study the feasibility of a multicenter randomized trial to assess the effects of a healthcare intervention based on the alert from the Présage Care device after discharge from hospital for patients hospitalized for heart failure (MCO and SSR).

Background and participants: This is a feasibility study carried out on two hospital wards for heart failure patients aged 65 and over (MCO and SSR). Patient's relative will be asked to fill in a short questionnaire twice a week for each beneficiary, relating to the beneficiary's daily life (input time not to exceed 2 minutes). This information will be transmitted in real time to PRESAGE CARE's secure platform (health data host). The study will last 6 months, with a 3-month inclusion period and an expected average follow-up of 3 months. It is planned to include 50 to 100 patients, with the same number of caregivers, and to study recruitment rates, participant satisfaction (hospital doctors, patients, caregivers, general practitioners), drop-out rates and the usefulness of updating the PRESAGE CARE algorithms in the context of the risk of re-hospitalization heart failure patients.

Data collected: In addition to inclusion data to describe the participant population, informations on emergency department visits, hospitalizations, drugs prescribed and dispensed, and long-term care status will be extracted from the hospital information system .

The study will establish the usefulness of conducting a subsequent randomized multicenter study on the added value of the PRESAGE CARE system for this specific population.

Conditions

Interventions

DEVICE

PRESAGE CARE

PRESAGE Care informations from the application will be processed by the PRESAGE Care algorithm in real time, and may generate alerts indicating an increased risk of hospitalization or emergency department visits within 7 to 14 days. These alerts will be transmitted to a Care Manager platform, who will analyse the situation, initiate the healthcare intervention and coordinate its implementation. In practice, a care manager (coordinating nurse) will process the alert and carry out an initial assessment of the beneficiary's situation, using the information feedback platform, then by telephone, contacting the older adults beneficiary and the relative. The care manager may or may not implement preventive measures. If necessary, the patient may be offered an outpatient medical consultation, a home visit, a consultation with his or her GP and/or social or paramedical interventions.

Sponsors & Collaborators

  • Assistance Publique Hopitaux De Marseille

    collaborator OTHER
  • Presage

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-01
Primary Completion
2024-03-01
Completion
2024-07-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06018532 on ClinicalTrials.gov