Frail Elderly SyndromeNCT06018532
Medical Monitoring of Older Adults Patients After Discharged From Heart Failure Hospitalization
A study testing PRESAGE CARE in people with Frail Elderly Syndrome and Heart Failure, run by Presage.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frail Elderly Syndrome, Heart Failure
- What is being tested?
- PRESAGE CARE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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).
Read more
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.
Read the 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.
- Conditions
- Frail Elderly Syndrome, Heart Failure
- Being tested
- PRESAGE CARE
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRESAGE CAREDevice
Also called Intervention (nurses and physicians)
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Device: PRESAGE CARE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability at inclusion by the patient-relative pair using PRESAGE Care
Rate of relatives participating in the study (%)
Measured: through study completion, an average of 6 months
Secondary outcomes (3)
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%
Measured: through study completion, an average of 6 months
Relevance of follow-up
Rate of alerts leading to intervention (%) Satisfaction level of referring physicians
Measured: through study completion, an average of 6 months
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)
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frail Elderly SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Presage
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Assistance Publique Hopitaux De Marseille
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06018532
- Sponsor's protocol ID
- Presage_IC
- Status last verified
- Aug 2023
- First submitted
- 22 Aug 2023
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Monitoring of Older Adults Patients After Discharged From Heart Failure Hospitalization
- ClinicalTrials.gov ID
- NCT06018532
- Acronym / sponsor ID
- Presage_IC
- Conditions
- Frail Elderly Syndrome, Heart Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- PresageIndustry (pharma, biotech, devices)
- Collaborators
- Assistance Publique Hopitaux De Marseille
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 30 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: PRESAGE CARE |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRESAGE CAREAlso: Intervention (nurses and physicians)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. | Device | Intervention |
Primary outcome
Acceptability at inclusion by the patient-relative pair using PRESAGE Care
Time frame: through study completion, an average of 6 months
Rate of relatives participating in the study (%)
3 secondary outcomes
Acceptability of the relative
Time frame: through study completion, an average of 6 months
Relevance of follow-up
Time frame: through study completion, an average of 6 months
impact on emergency hospitalization
Time frame: through study completion, an average of 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing PRESAGE CARE in people with Frail Elderly Syndrome and Heart Failure, run by Presage.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jacques-Henry Veyron, MS (0622152004 ext. +33, jhveyron@presage.care), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability at inclusion by the patient-relative pair using PRESAGE Care (time frame: through study completion, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023.