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

31 december 2021 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Verwacht)

248

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Frankrijk
    • Occitanie
      • Montpellier, Occitanie, Frankrijk, 34295
        • Werving
        • University Hospital of Montpellier Cardiology departments oh the Montpellier, Nîmes and Toulouse University Hospitals
        • Contact:
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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
Ander: Reinforced multidisciplinary follow-up
Reinforced multidisciplinary follow-up
Geen tussenkomst: 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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Rehospitalisation for heart failure
Tijdsspanne: Call at 3 months after hospitalisation discharge
At least one rehospitalisation with heart failure related cause
Call at 3 months after hospitalisation discharge

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Prescriptions conformity rates compared to heart failure recommendations edited by the European Society of Cardiology in 2016
Tijdsspanne: 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
Tijdsspanne: Call at 3 months after hospitalisation discharge
Evaluated by a pharmacist
Call at 3 months after hospitalisation discharge
Compliance level
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Call at 3 months after hospitalisation discharge
Evaluated by a pharmacist
Call at 3 months after hospitalisation discharge
Death rate
Tijdsspanne: Call at 3 months after hospitalisation discharge
Evaluated by a pharmacist
Call at 3 months after hospitalisation discharge
Time before death
Tijdsspanne: 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
Tijdsspanne: Call at 3 months after hospitalisation discharge
Evaluated by a pharmacist
Call at 3 months after hospitalisation discharge
Quality of life score
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 3 months after hospitalisation discharge
3 months after hospitalisation discharge

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University Hospital, Montpellier

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

2 augustus 2019

Primaire voltooiing (Verwacht)

1 februari 2022

Studie voltooiing (Verwacht)

1 augustus 2022

Studieregistratiedata

Eerst ingediend

27 maart 2019

Eerst ingediend dat voldeed aan de QC-criteria

1 april 2019

Eerst geplaatst (Werkelijk)

3 april 2019

Updates van studierecords

Laatste update geplaatst (Werkelijk)

4 januari 2022

Laatste update ingediend die voldeed aan QC-criteria

31 december 2021

Laatst geverifieerd

1 december 2021

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • RECHMPL18_0040

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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