search
Back to results

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

Primary Purpose

Frail Elderly Syndrome, Heart Failure

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PRESAGE CARE
Sponsored by
Presage
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Frail Elderly Syndrome

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Intervention

    Arm Description

    Outcomes

    Primary Outcome Measures

    Acceptability at inclusion by the patient-relative pair using PRESAGE Care
    Rate of relatives participating in the study (%)

    Secondary Outcome Measures

    Acceptability of the relative
    a regular follow-up rate, characterization of the caregiver (gender ratio (%), average age (years), status (% of children, % of spouse % of husband, % of others). Validation : more than 50%
    Relevance of follow-up
    Rate of alerts leading to intervention (%) Satisfaction level of referring physicians
    impact on emergency hospitalization
    Tracking of re-hospitalization and emergency room admission rates (%) Lost to follow-up rate (%) Average length of stay for re-hospitalization in the facility (days) Time to re-hospitalization or emergency (days)

    Full Information

    First Posted
    August 22, 2023
    Last Updated
    August 25, 2023
    Sponsor
    Presage
    Collaborators
    Assistance Publique Hopitaux De Marseille
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT06018532
    Brief Title
    Medical Monitoring of Older Adults Patients After Discharged From Heart Failure Hospitalization
    Official Title
    Medical Monitoring of Older Adults Patients After Discharged From Heart Failure Hospitalization
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2023 (Anticipated)
    Primary Completion Date
    March 1, 2024 (Anticipated)
    Study Completion Date
    July 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Presage
    Collaborators
    Assistance Publique Hopitaux De Marseille

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    Heart failure is a condition with a poor prognosis, especially in older adults with a difficult management. Overall, the mortality rate increases with age, rising by 27% per decade in men and 61% per decade in women. The management and monitoring of heart failure rely on the appropriate prescription of drugs with beneficial effect on heart muscle remodeling (ACE inhibitors, beta-blockers), with a regular reevaluation for a best efficacy as well as a good bservance of hygienic-dietary rules such as regular weight control, simple nutritional rules (salt and water intake), and the maintenance of physical activity and training. The main aim of ambulatory services is to detect episodes of decompensation early to treat it rapidly and prevent hospitalization. In the absence of improvement, hospitalization is necessary. Once discharged from the health care facility, coordination with the town or host structure is essential to ensure appropriate continuity of care. Poor publications have already shown the benefits of Machine Learning (ML) for predicting hospitalization and death in heart failure patients. Predictive performance ranges from average (AUC: 0.55) to very good (AUC 0.8). However, to work, these models require a large number of highly medicalized variables (typically over a hundred, including medication, medical history, ECG....), making them very difficult to apply in real life. On the other hand, satisfactory predictive models (AUC>0.7) have large temporal prediction windows (1 to 3 years), making health actions difficult to implement. To the best of our knowledge, no publication presents a short prediction window (a few weeks) based on simple models (less than 15 variables with little medicalization). The PRESAGE Care medical device makes it possible to observe functional changes potentially heralding major medical events, and significantly improves predictions compared with conventional models. Caregivers fill in an easy-to-use application (less than 2 minutes), create to predict the risk of a serious event (hospitalization, loss of autonomy, etc.). An alert is sent to the end-users, who are the healthcare professionals, to trigger a healthcare intervention that could, in some cases, prevent the situation from deteriorating, or enable it to be managed in a non-emergency context. This study is based on the hypothesize that the use of the PRESAGE CARE device coupled with a health intervention based on existing health networks could be associated with a lower incidence of unscheduled re-hospitalization, with no difference in mortality. This study is based on the hypothesize that the device will be well accepted by beneficiaries, their relatives and healthcare professionals (satisfaction > 80%), and that the intervention will not be associated with an increase in healthcare expenditure, as the additional costs associated with the use of PRESAGE CARE will be offset by the reduction in expenditure linked to avoided hospitalizations.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Frail Elderly Syndrome, Heart Failure

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Intervention Type
    Device
    Intervention Name(s)
    PRESAGE CARE
    Other Intervention Name(s)
    Intervention (nurses and physicians)
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Acceptability at inclusion by the patient-relative pair using PRESAGE Care
    Description
    Rate of relatives participating in the study (%)
    Time Frame
    through study completion, an average of 6 months
    Secondary Outcome Measure Information:
    Title
    Acceptability of the relative
    Description
    a regular follow-up rate, characterization of the caregiver (gender ratio (%), average age (years), status (% of children, % of spouse % of husband, % of others). Validation : more than 50%
    Time Frame
    through study completion, an average of 6 months
    Title
    Relevance of follow-up
    Description
    Rate of alerts leading to intervention (%) Satisfaction level of referring physicians
    Time Frame
    through study completion, an average of 6 months
    Title
    impact on emergency hospitalization
    Description
    Tracking of re-hospitalization and emergency room admission rates (%) Lost to follow-up rate (%) Average length of stay for re-hospitalization in the facility (days) Time to re-hospitalization or emergency (days)
    Time Frame
    through study completion, an average of 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jacques-Henry Veyron, MS
    Phone
    0622152004
    Ext
    +33
    Email
    jhveyron@presage.care
    First Name & Middle Initial & Last Name or Official Title & Degree
    Charlotte THERY, PhD
    Phone
    0618312856
    Ext
    +33
    Email
    cthery@presage.care

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs