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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Ferrara
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Cona, Ferrara, 이탈리아, 44124
- University Hospital of Ferrara
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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다른: good clinical practice
all patients will receive education from physician regarding management of dual antiplatelet therapy as part of the routine discharge process
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education from physician regarding dual antiplatelet therapy as part of the routine discharge process
다른 이름들:
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실험적: bundle group
patients assigned to the bundle group will receive visits and materials as described by the protocol (counseling)
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visits and materials describing advantages and side effects of dual antiplatelet therapy and their management
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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quality of life
기간: 1 month
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quality of life assessment in each patient by EQ-5D questionnaire
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1 month
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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emergency room admission
기간: 1 month
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number of access to emergency room service for bleeding
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1 month
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general practitioner visit
기간: 1 month
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number of access to general practitioner for bleeding
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1 month
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dyspnea occurrence
기간: 1 month
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number of patients suffering dyspnoea stratified according P2Y12 inhibitors
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1 month
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bleeding academic research consortium (BARC) 2-3
기간: 1 month
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occurrence of BARC 2-3 complications
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1 month
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bleeding academic research consortium (BARC) 1
기간: 1 month
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occurrence of BARC 1 complications
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1 month
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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ischemic adverse events
기간: 1 year
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cumulative incidence of the following ischemic adverse events: cardiac death, myocardial infarction, transient ischemic attack/stroke
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1 year
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all-cause mortality
기간: 1 year
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occurrence of all-cause death
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1 year
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BARC 1-3
기간: 1 year
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occurrence of BARC1-3 complications
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1 year
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공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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