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Optimized Medico-pharmaceutical Collaboration in the Drug Management of Patients With Heart Failure (COMPIC)

31 dicembre 2021 aggiornato da: University Hospital, Montpellier

Interest of an Optimized Medico-pharmaceutical Collaboration in the Drug Management of Patients With Heart Failure: Controlled, Randomized, Multicentric Study

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Heart failure (FH) is a public health problem with an estimated prevalence of about 1.5% in developed countries. In 2013, the number of patients hospitalized in France for heart failure amounted to 165 231 and 20% of them were re-hospitalized at least once for the same reason during this year. Several factors contribute to the occurrence of cardiac decompensation (DC) : some modifiable (age, severity of IC, etiology ...) and others modifiable, such as therapeutics. Various elements could reduce the frequency of re-hospitalizations and the mortality due to this disease :

  • a better knowledge of treatments by patients and consequently a better therapeutic compliance
  • a better knowledge of the factors and signs of DC (low-sodium diet, weighing...)
  • a better implementation of prescribing recommendations : less than 50% of patients have optimal treatment compared to ESC recommendations
  • a better communication at the transition points of the patient pathway. The creation of a binomial cardiologist-clinical pharmacist during hospitalization and the maintenance of this optimized multidisciplinary follow-up within 3 months post-hospitalization is a proposal to intervene on these factors. Indeed, the clinical pharmacist (present in the care unit) works in collaboration with the medical and paramedical teams and can improve the care of patients. In the experimental group, a specific multidisciplinary consultation is planned for one month after the end of the hospitalization. A 3-month follow-up visit will be carried out by phone call to meet the criteria for readmission, mortality, quality of life, adherence and persistence of treatments.

Tipo di studio

Interventistico

Iscrizione (Anticipato)

248

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Francia
    • Occitanie
      • Montpellier, Occitanie, Francia, 34295
        • Reclutamento
        • University Hospital of Montpellier Cardiology departments oh the Montpellier, Nîmes and Toulouse University Hospitals
        • Contatto:
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Reinforced multidisciplinary follow-up

Entrance medication reconciliation performed by a pharmacist

  • Patient compliance evaluation
  • Patient quality of life evaluation
  • Pharmaceutical analysis with focus on medication optimization with a specific check-list (according to ESC 2016 recommendations)
  • Hospitalisation discharge medication reconciliation
  • Patient pharmaceutic interview at the hospitalisation discharge
  • Transmission of informations to the general practitioner and the pharmacist's patient
  • Multidisciplinary consult at 1 month after hospitalisation discharge
Altro: Reinforced multidisciplinary follow-up
Reinforced multidisciplinary follow-up
Nessun intervento: Standard care
  • Drug review by a paramedic or a pharmacist
  • Pharmaceutical analysis
  • Therapeutic optimisation based on the usual practices care of the cardiologic department
  • Writing of the prescription given on leaving hospital based on the usual care of the department
  • Treatments explanations and support to the patient on the usual care
  • Transmission of the hospitalisation report to the patient general practitioner as the usual practice
  • Medical consult in usual time frames (an average of 1 month after hospitalisation discharge) at the patient location of choice

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Rehospitalisation for heart failure
Lasso di tempo: Call at 3 months after hospitalisation discharge
At least one rehospitalisation with heart failure related cause
Call at 3 months after hospitalisation discharge

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Prescriptions conformity rates compared to heart failure recommendations edited by the European Society of Cardiology in 2016
Lasso di tempo: At hospitalisation discharge (Day 0)
Evaluated by a pharmacist
At hospitalisation discharge (Day 0)
Prescriptions conformity rates compared to heart failure recommendations edited by the European Society of Cardiology in 2016
Lasso di tempo: Call at 3 months after hospitalisation discharge
Evaluated by a pharmacist
Call at 3 months after hospitalisation discharge
Compliance level
Lasso di tempo: At hospitalisation discharge (Day 0)

Evaluated by the " Girerd medication adherence questionnaire "

The " Girerd medication adherence questionnaire " contains 6 questions which answers are " yes " or " no ". The number of " yes " responses permits to evaluate the level of the patient medication adherence as following :

0 yes : good compliance

1 or 2 yes : minor non compliance 3 or more yes : non compliance
At hospitalisation discharge (Day 0)
Compliance level
Lasso di tempo: At 1 month after hospitalisation discharge for the experimental group only

Evaluated by the "Girerd medication adherence questionnaire" Evaluated by the " Girerd medication adherence questionnaire "

The " Girerd medication adherence questionnaire " contains 6 questions which answers are " yes " or " no ". The number of " yes " responses permits to evaluate the level of the patient medication adherence as following :

0 yes : good compliance

1 or 2 yes : minor non compliance 3 or more yes : non compliance
At 1 month after hospitalisation discharge for the experimental group only
Compliance level
Lasso di tempo: Call at 3 months after hospitalisation discharge

Evaluated by the "Girerd medication adherence questionnaire" Evaluated by the " Girerd medication adherence questionnaire "

The " Girerd medication adherence questionnaire " contains 6 questions which answers are " yes " or " no ". The number of " yes " responses permits to evaluate the level of the patient medication adherence as following :

0 yes : good compliance

1 or 2 yes : minor non compliance 3 or more yes : non compliance
Call at 3 months after hospitalisation discharge
Treatment persistence rates
Lasso di tempo: Call at 3 months after hospitalisation discharge
Evaluated by a pharmacist
Call at 3 months after hospitalisation discharge
Death rate
Lasso di tempo: Call at 3 months after hospitalisation discharge
Evaluated by a pharmacist
Call at 3 months after hospitalisation discharge
Time before death
Lasso di tempo: Call at 3 months after hospitalisation discharge
Evaluated by a pharmacist
Call at 3 months after hospitalisation discharge
Time of occurrence of a potential rehospitalisation related to the disease
Lasso di tempo: Call at 3 months after hospitalisation discharge
Evaluated by a pharmacist
Call at 3 months after hospitalisation discharge
Quality of life score
Lasso di tempo: Call at 3 months after hospitalisation discharge
Evaluated by the Minnesota Living with Heart Failure Questionnaire the Minnesota Living with Heart Failure Questionnaire contains 21 questions. Each of the 21 questions ask the patients to indicate how much a possible effect of heart failure have affected their ability to live as wanted during the past month using a scale from 0 (not present or no effect), 1 (very little), 2, 3, 4, or 5 (very much).The measurement of heart failure severity is assessed by summing the responses that ranges from 0 to 105.
Call at 3 months after hospitalisation discharge
Satisfaction of the patient
Lasso di tempo: Call at 3 months after hospitalisation discharge
Evaluated by Likert scale This questionnaire indicates the degree of patient satisfaction using 9 questions which explore the improvement of patient behavior concerning disease and treatment. The measurement of satisfaction is assessed by summing the responses that range from 9 (unsatisfied) to 36 (very satisfied)
Call at 3 months after hospitalisation discharge
Satisfaction of health professionals
Lasso di tempo: online questionnaire at 3 months after hospitalisation discharge
Evaluated by Likert scale (only for interventional arm) This questionnaire indicates the degree of health professional satisfaction using 6 questions which explore the improvement of transition between hospital to community and comprehension of therapeutic optimization. The measurement of satisfaction is assessed by summing the responses that range from 6 (unsatisfied) to 24 (very satisfied)
online questionnaire at 3 months after hospitalisation discharge
Incremental cost-effectiveness ratio
Lasso di tempo: 3 months after hospitalisation discharge
3 months after hospitalisation discharge

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University Hospital, Montpellier

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

2 agosto 2019

Completamento primario (Anticipato)

1 febbraio 2022

Completamento dello studio (Anticipato)

1 agosto 2022

Date di iscrizione allo studio

Primo inviato

27 marzo 2019

Primo inviato che soddisfa i criteri di controllo qualità

1 aprile 2019

Primo Inserito (Effettivo)

3 aprile 2019

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 gennaio 2022

Ultimo aggiornamento inviato che soddisfa i criteri QC

31 dicembre 2021

Ultimo verificato

1 dicembre 2021

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • RECHMPL18_0040

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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