UnknownNot Applicable

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

100 participantsStarted 2023-12-01

Plain-language 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.

Who can participate

Age range

65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: through study completion, an average of 6 months

Trial details

NCT IDNCT06018532

SponsorPresage

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-03-01

Contact for this trial

Jacques-Henry Veyron, MS

0622152004 jhveyron@presage.care

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