Predischarge Bundle to Minimize Negative Impact on Quality of Life of Nuisance Bleedings (BATMAN)
Predischarge Bundle for Patients in Dual Antiplatelet Therapy to Minimize the Negative Impact of Nuisance Bleedings on Quality of Life: a Randomized Controlled Trial.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
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Ferrara
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Cona, Ferrara, Italië, 44124
- University Hospital Of Ferrara
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-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Ander: good clinical practice
all patients will receive education from physician regarding management of dual antiplatelet therapy as part of the routine discharge process
|
education from physician regarding dual antiplatelet therapy as part of the routine discharge process
Andere namen:
|
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Experimenteel: bundle group
patients assigned to the bundle group will receive visits and materials as described by the protocol (counseling)
|
visits and materials describing advantages and side effects of dual antiplatelet therapy and their management
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
quality of life
Tijdsspanne: 1 month
|
quality of life assessment in each patient by EQ-5D questionnaire
|
1 month
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
emergency room admission
Tijdsspanne: 1 month
|
number of access to emergency room service for bleeding
|
1 month
|
|
general practitioner visit
Tijdsspanne: 1 month
|
number of access to general practitioner for bleeding
|
1 month
|
|
dyspnea occurrence
Tijdsspanne: 1 month
|
number of patients suffering dyspnoea stratified according P2Y12 inhibitors
|
1 month
|
|
bleeding academic research consortium (BARC) 2-3
Tijdsspanne: 1 month
|
occurrence of BARC 2-3 complications
|
1 month
|
|
bleeding academic research consortium (BARC) 1
Tijdsspanne: 1 month
|
occurrence of BARC 1 complications
|
1 month
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
ischemic adverse events
Tijdsspanne: 1 year
|
cumulative incidence of the following ischemic adverse events: cardiac death, myocardial infarction, transient ischemic attack/stroke
|
1 year
|
|
all-cause mortality
Tijdsspanne: 1 year
|
occurrence of all-cause death
|
1 year
|
|
BARC 1-3
Tijdsspanne: 1 year
|
occurrence of BARC1-3 complications
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1 year
|
Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 150595
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