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

31 december 2021 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Förväntat)

248

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

  • Frankrike
    • Occitanie
      • Montpellier, Occitanie, Frankrike, 34295
        • Rekrytering
        • University Hospital of Montpellier Cardiology departments oh the Montpellier, Nîmes and Toulouse University Hospitals
        • Kontakt:
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Övrig
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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
Övrig: Reinforced multidisciplinary follow-up
Reinforced multidisciplinary follow-up
Inget ingripande: 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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Rehospitalisation for heart failure
Tidsram: Call at 3 months after hospitalisation discharge
At least one rehospitalisation with heart failure related cause
Call at 3 months after hospitalisation discharge

Sekundära resultatmått

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

Samarbetspartners och utredare

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Sponsor

University Hospital, Montpellier

Publikationer och användbara länkar

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Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

2 augusti 2019

Primärt slutförande (Förväntat)

1 februari 2022

Avslutad studie (Förväntat)

1 augusti 2022

Studieregistreringsdatum

Först inskickad

27 mars 2019

Först inskickad som uppfyllde QC-kriterierna

1 april 2019

Första postat (Faktisk)

3 april 2019

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

4 januari 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

31 december 2021

Senast verifierad

1 december 2021

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • RECHMPL18_0040

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