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

NCT06018532 | Unknown

• 1 other identifier: Presage_IC
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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

Frail Elderly Syndrome; Heart Failure

Outcome Measures

Primary Outcomes (1)

• Acceptability at inclusion by the patient-relative pair using PRESAGE Care

  Rate of relatives participating in the study (%)

  through study completion, an average of 6 months

Secondary Outcomes (3)

• Acceptability of the relative

  through study completion, an average of 6 months

• Relevance of follow-up

  through study completion, an average of 6 months

• impact on emergency hospitalization

  through study completion, an average of 6 months

Study Arms (1)

Intervention

EXPERIMENTAL

Device: PRESAGE CARE

Interventions

PRESAGE CARE DEVICE

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.

Also known as: Intervention (nurses and physicians)

Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Person aged 65 or over.
• Living at home
• Moderately dependent, defined as GIR 3, 4 or 5.
• Be or have been hospitalized in the last 30 days for heart failure
• Have a relative volunteer to enter the PRESAGE questionnaire at least twice a week
• Agreeing to take part in the study, or not objecting to the study being carried out, and whose relative agrees to take part.

You may not qualify if:

• People under 65 years of age
• With severe dependency defined by a GIR 1 or 2 group.
• Not dependent as defined by a GIR 6 group.
• Refusing to take part in the study, or whose relative refuses to take part.
• Older adult benefiting from the Prado heart failure program on discharge from hospital.

Sponsors & Collaborators

• Presage: lead
• Assistance Publique Hopitaux De Marseille: collaborator

MeSH Terms

Conditions

Heart Failure

Interventions

Methods

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Central Study Contacts

Jacques-Henry Veyron, MS

CONTACT

0622152004; jhveyron@presage.care

Charlotte THERY, PhD

CONTACT

0618312856; cthery@presage.care

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2023
• First Posted: August 30, 2023
• Study Start: December 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: July 1, 2024
• Last Updated: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share