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NCT04613973: PRADO_IC2
Evaluation of the Program to Help Return Home Patients Hospitalized for Heart Failure, From Paris Saint-Joseph Hospital
trial in Heart Failure in 633 participants. Completed in 17 August 2022.
31 January 2022
Quick facts
| Lead sponsor | Fondation Hôpital Saint-Joseph |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 633 |
| Start date | 28 November 2020 |
| Primary completion | 31 January 2022 |
| Estimated completion | 17 August 2022 |
| Sites | 1 location across France |
Conditions studied
- Heart Failure — all drugs for Heart Failure →
Sponsor
Fondation Hôpital Saint-Joseph — full company profile →
Who can join
18 and older, any sex, with Heart Failure. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The prevalence of heart failure is very high worldwide is between 1 and 2% in developed countries. The French Federation of Cardiology estimates that a million people are affected in France. Each year in France, there are nearly 70,000 deaths linked to heart failure, and more than 150,000 hospitalizations with an average cumulative duration per year of 12.7 days, figures which show the extent of the phenomenon. Heart failure is therefore a common pathology, which constitutes an important public health issue. It requires rigorous monitoring and early adaptation of treatments to avoid repeated hospitalizations. Studies show that following hospitalization for heart failure, all-cause re-hospitalization rates rise to 18% within 30 days. In 2019, the rate of re-hospitalization at 1 year is 30%, half of which in the following 3 months. The prognosis is grim with 20 to 30% of deaths within the year. The European Society of Cardiology recommends that the patient be integrated into a care path coordinated by the general practitioner; and a consultation with his general practitioner in the week after hospitalization and his cardiologist within two weeks. The CPAM (Caisse Primaire d'Assurance Maladie) has set up since 2013 the PRADO-IC program (Program for Return to Home Hospital for Heart Failure). This program must be in place before discharge from hospital. A health insurance advisor comes to meet the patient, declared eligible for PRADO by the hospital medical team, to present the offer and collect his approval before discharge. He then contacts the attending physician and organizes his return home. A follow-up book is given to the patient to allow better transmission of information between town and hospital. A specially trained nurse visits the patient's home every week. The duration of PRADO support varies according to the NYHA stage of severity. It provides therapeutic education with reinforcement of hygieno-dietetic rules, warning signs, checks compliance with treatments and the necessary biological monitoring and must alert the attending physician in the event of aggravation. The objectives of this program are: to preserve the quality of life and the autonomy of patients, to support the reduction of the length of stay in hospital, to strengthen the quality of care in town around the attending physician, improve the efficiency of recourse to hospitalization by reserving the heaviest structures for the patients who need them most.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04613973
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Heart Failure
Currently open trials in the same condition.
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- NCT07263035 — Urine Sodium-Driven Diuretic Adjustment Strategy in Acute Decompensated Heart Failure · Phase 4 · recruiting
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Other Fondation Hôpital Saint-Joseph trials
Trials by the same sponsor.
- NCT07512960 — Duration of Dual Anti-Platelet Therapy in Chronic Limb Threatening Ischemia After Distal Revascularization · Phase 3 · not yet recruiting
- NCT07512908 — Study of Factors Influencing the Dynamics of Colonisation and Decolonisation of the Digestive Tract by Clostridioides Di · NA · not yet recruiting
- NCT07512830 — Evaluation of the Benefits of Hypnosis During Transoesophageal Echocardiography · NA · recruiting
- NCT07348081 — Real World Evidence to Assess the Value of a Digital Care Coordination and Monitoring Program for Supporting Caregivers · NA · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04613973 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fondation Hôpital Saint-Joseph
- Last refreshed: 19 August 2022
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