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

2021년 12월 31일 업데이트: 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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (예상)

248

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

  • 프랑스
    • Occitanie
      • Montpellier, Occitanie, 프랑스, 34295
        • 모병
        • University Hospital of Montpellier Cardiology departments oh the Montpellier, Nîmes and Toulouse University Hospitals
        • 연락하다:
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 다른
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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
다른: Reinforced multidisciplinary follow-up
Reinforced multidisciplinary follow-up
간섭 없음: 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

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Rehospitalisation for heart failure
기간: Call at 3 months after hospitalisation discharge
At least one rehospitalisation with heart failure related cause
Call at 3 months after hospitalisation discharge

2차 결과 측정

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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University Hospital, Montpellier

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2019년 8월 2일

기본 완료 (예상)

2022년 2월 1일

연구 완료 (예상)

2022년 8월 1일

연구 등록 날짜

최초 제출

2019년 3월 27일

QC 기준을 충족하는 최초 제출

2019년 4월 1일

처음 게시됨 (실제)

2019년 4월 3일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2022년 1월 4일

QC 기준을 충족하는 마지막 업데이트 제출

2021년 12월 31일

마지막으로 확인됨

2021년 12월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • RECHMPL18_0040

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

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. .

심부전에 대한 임상 시험

Reinforced multidisciplinary follow-up에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Macedonia

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

3
구독하다