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Predischarge Bundle to Minimize Negative Impact on Quality of Life of Nuisance Bleedings (BATMAN)

1. maj 2018 opdateret af: Gianluca Campo, University Hospital of Ferrara

Predischarge Bundle for Patients in Dual Antiplatelet Therapy to Minimize the Negative Impact of Nuisance Bleedings on Quality of Life: a Randomized Controlled Trial.

A single-center, randomized trial of admitted patients with ischemic heart disease receiving percutaneous coronary intervention and stent implantation will be conducted at University Hospital of Ferrara. Patients will be randomized to either the control (standard care) or the bundle group in which patients will receive counseling regarding dual antiplatelet therapy management, advantages and side effects, screening for depression or anxiety, standardized education. The primary endpoint will be the difference in the quality of life as assessed by EQ-5D questionnaire.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Recent studies suggest that bleeding complications have a strong influence on quality of life. During DAPT regimen bleeding complications occur from 5% to 15% of patients. Nuisance bleedings (BARC 1 bleeding) occur more frequently and show a strong influence on quality of life, depression, anxiety and compliance to the treatment.

The aim of the study is to establish if a specific counseling programme might minimize the negative quality of life impact of nuisance bleedings. A computer-generated list will be used to randomize patients in a 1:1 ratio, stratified by age, sex, renal failure and P2Y12 inhibitor, to either the bundle or the control group.

All patients randomized to the control group (standard of care) will receive education from physician regarding dual antiplatelet therapy (DAPT) as part of the routine discharge process.

All patients randomized to the bundle group will receive:

i) a 15-min visit by a member of the research team 24 h prior to the anticipated discharge day. During this visit, a core set of DAPT risks will be addressed. Advantages and side effects of DAPT will be described. The importance of compliance will be discussed. The correct management of side effects (especially BARC 1 bleedings) will be discussed.

ii) a 15-min visit by a member of the research team with a family member living near/with the patient. Advantages and side effects of DAPT will be described. The importance of compliance will be discussed. The correct management of side effects (especially BARC 1 bleedings) will be discussed.

iii) brochure describing advantages, side effects and management of dual antiplatelet therapy. Contemporaneously, the investigators of the study will contact directly by phone and/or mail the general practionnaire of the patient to describe and explain the same topics and the clinical problem of her patient.

iv) availability of phone number to discuss potential side effects of DAPT. In addition, the study coordinator of the study will contact two times by month the patient by phone to assess DAPT compliance and potential BARC 1 bleedings.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

448

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Italien
    • Ferrara
      • Cona, Ferrara, Italien, 44124
        • University Hospital of Ferrara

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • signed written informed consent
  • hospital admission for ischemic heart disease with clinical indication to coronary artery angiography
  • percutaneous coronary intervention and drug eluting stent implantation
  • indication to dual antiplatelet therapy for at least 6 months

Exclusion Criteria:

  • oral anticoagulant therapy
  • bleeding event in the 30 days before the enrolment
  • planned surgery

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: good clinical practice
all patients will receive education from physician regarding management of dual antiplatelet therapy as part of the routine discharge process
Adfærdsmæssigt: good clinical practice
education from physician regarding dual antiplatelet therapy as part of the routine discharge process
Andre navne:
  • plejestandard
Eksperimentel: bundle group
patients assigned to the bundle group will receive visits and materials as described by the protocol (counseling)
Adfærdsmæssigt: bundle group
visits and materials describing advantages and side effects of dual antiplatelet therapy and their management
Andre navne:
  • counseling regarding dual antiplatelet therapy management

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
quality of life
Tidsramme: 1 month
quality of life assessment in each patient by EQ-5D questionnaire
1 month

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
emergency room admission
Tidsramme: 1 month
number of access to emergency room service for bleeding
1 month
general practitioner visit
Tidsramme: 1 month
number of access to general practitioner for bleeding
1 month
dyspnea occurrence
Tidsramme: 1 month
number of patients suffering dyspnoea stratified according P2Y12 inhibitors
1 month
bleeding academic research consortium (BARC) 2-3
Tidsramme: 1 month
occurrence of BARC 2-3 complications
1 month
bleeding academic research consortium (BARC) 1
Tidsramme: 1 month
occurrence of BARC 1 complications
1 month

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
ischemic adverse events
Tidsramme: 1 year
cumulative incidence of the following ischemic adverse events: cardiac death, myocardial infarction, transient ischemic attack/stroke
1 year
all-cause mortality
Tidsramme: 1 year
occurrence of all-cause death
1 year
BARC 1-3
Tidsramme: 1 year
occurrence of BARC1-3 complications
1 year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Hospital of Ferrara

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. september 2015

Primær færdiggørelse (Faktiske)

1. marts 2016

Studieafslutning (Faktiske)

1. marts 2017

Datoer for studieregistrering

Først indsendt

17. september 2015

Først indsendt, der opfyldte QC-kriterier

17. september 2015

Først opslået (Skøn)

18. september 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. maj 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. maj 2018

Sidst verificeret

1. maj 2018

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 150595

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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