Interest of an Optimized Medico-pharmaceutical Collaboration in the Drug Management of Patients With Heart Failure: Controlled, Randomized, Multicentric Study
Trial tests coordinated care for heart failure patients.
Plain English Summary
Optimized Medico-pharmaceutical Collaboration in the Drug Management of Patients With Heart Failure is a Not Applicable clinical trial sponsored by University Hospital, Montpellier studying Heart Failure. This study tests a special program where doctors and pharmacists work closely together to manage heart failure medications. It is for adult patients hospitalized for heart failure. Participation involves being randomly assigned to either the special coordinated care program or the usual care. The alternative is standard medical care for heart failure. The trial aims to enroll 229 participants.
Official Summary
This is a controlled, randomized, open-label, multicentric study evaluating the value of coordinated medico-pharmaceutical management compared to standard management in patients with heart failure. The aim of this study is to evaluate the impact of these optimized activities on the re-hospitalization of the patient with cardiac insufficiency for a disease-related event within three months of the initial hospitalization.
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults over 18 years old admitted to a cardiology department for heart failure. Patients must be covered by a social security system and able to give informed consent. Individuals who cannot manage their own medications, live in an institution, or are in another trial are excluded. Patients with severe health issues that might interfere with participation are also excluded. This trial is studying Heart Failure, so participants generally need a confirmed diagnosis.
What They're Measuring
The main goal is to see if patients are readmitted to the hospital for heart failure within three months of being discharged, indicating how well the new care approach works. The specific primary outcome measures are: Rehospitalisation for heart failure (Call at 3 months after hospitalisation discharge). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial matters because it aims to improve how heart failure patients are cared for after leaving the hospital, potentially reducing readmissions. This research targets Heart Failure, where improved treatment options are needed.
Investor Insight
This study focuses on improving patient management rather than a new drug, suggesting potential for operational efficiency gains in healthcare systems and a market for better care coordination service
Is This Trial Right for Me?
Ask your doctor if this coordinated care program is right for you and what it involves. Understand how your medications will be managed and if you'll have regular check-ins with both doctors and pharmacists. Be prepared for follow-up calls or visits to monitor your condition and medication adherence. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 229 participants
Interventions
- OTHER: Reinforced multidisciplinary follow-up — Reinforced multidisciplinary follow-up
Primary Outcomes
- Rehospitalisation for heart failure (Call at 3 months after hospitalisation discharge)
Secondary Outcomes
- Prescriptions conformity rates compared to heart failure recommendations edited by the European Society of Cardiology in 2016 (At hospitalisation discharge (Day 0))
- Prescriptions conformity rates compared to heart failure recommendations edited by the European Society of Cardiology in 2016 (Call at 3 months after hospitalisation discharge)
- Compliance level (At hospitalisation discharge (Day 0))
- Compliance level (At 1 month after hospitalisation discharge for the experimental group only)
- Compliance level (Call at 3 months after hospitalisation discharge)
Full Eligibility Criteria
Inclusion Criteria: * Patient aged more than 18 years * Adult patient admitted in cardiology department (full hospitalisation or intensive care) for heart failure no matter the type and the stage of the disease * Person affiliated or beneficiary of a social security system * Collection of a free, informed, express and written consent Exclusion Criteria: * Non autonomous drug management patients and not disposing * a present caregiver during hospitalisation * Patients living in an institution * Person participating in another clinical trial with an exclusion period still ongoing * Person whose physical and/or psychological health is severely altered, and which, in the opinion of the investigator, may affect the participation's to the study * Person deprived of his rights, person under tutorship or guardianship * Refusal to sign the consent
Trial Locations
- University Hospital of Montpellier Cardiology departments oh the Montpellier, Nîmes and Toulouse University Hospitals, Montpellier, Occitanie, France
Frequently Asked Questions
What is clinical trial NCT03902028?
NCT03902028 is a Not Applicable INTERVENTIONAL study titled "Optimized Medico-pharmaceutical Collaboration in the Drug Management of Patients With Heart Failure." It is currently completed and is sponsored by University Hospital, Montpellier. The trial targets enrollment of 229 participants.
What conditions does NCT03902028 study?
This trial investigates treatments for Heart Failure. The primary condition under study is Heart Failure.
What treatments are being tested in NCT03902028?
The interventions being studied include: Reinforced multidisciplinary follow-up (OTHER). Reinforced multidisciplinary follow-up
What does Not Applicable mean for NCT03902028?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT03902028?
This trial is currently "Completed." It started on 2019-08-02. The estimated completion date is 2025-01-25.
Who is sponsoring NCT03902028?
NCT03902028 is sponsored by University Hospital, Montpellier. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT03902028?
The trial aims to enroll 229 participants. The trial status is completed.
How is NCT03902028 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT03902028?
The primary outcome measures are: Rehospitalisation for heart failure (Call at 3 months after hospitalisation discharge). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT03902028 being conducted?
This trial is being conducted at 1 site, including Montpellier, Occitanie (France).
Where can I find official information about NCT03902028?
The official record for NCT03902028 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT03902028. This government database provides the most up-to-date and detailed information about the trial.
What is NCT03902028 testing in simple terms?
This study tests a special program where doctors and pharmacists work closely together to manage heart failure medications. It is for adult patients hospitalized for heart failure.
Why is this trial significant?
This trial matters because it aims to improve how heart failure patients are cared for after leaving the hospital, potentially reducing readmissions.
What are the potential risks of participating in NCT03902028?
The main risk is that the new care approach may not be more effective than standard care in preventing hospital readmissions. Potential side effects are related to heart failure itself and its medications, which are managed under both study arms. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT03902028?
Ask your doctor if this coordinated care program is right for you and what it involves. Understand how your medications will be managed and if you'll have regular check-ins with both doctors and pharmacists. Be prepared for follow-up calls or visits to monitor your condition and medication adherence. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT03902028 signal from an investment perspective?
This study focuses on improving patient management rather than a new drug, suggesting potential for operational efficiency gains in healthcare systems and a market for better care coordination service This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves being randomly assigned to either the special coordinated care program or the usual care. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
More Heart Failure Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.