EHRA-PATHS: 새로운 치료 경로의 임상 및 보건 경제적 평가 (EHRA-PATHS)
EHRA-PATHS: 학제 간, 환자 중심의 체계적 치료 경로를 통해 노인 심방 세동 환자의 복합상병 해결 - 새로운 치료 경로의 임상 및 건강 경제적 평가
In elderly atrial fibrillation (AF) patients, AF is usually a manifestation of risk factors and comorbidities not only limited to cardiovascular diseases. Especially in elderly often more than two comorbidities are present. The presence of comorbidities also affects outcomes in AF patients. Current healthcare systems are single-disease focused, which increases the risk of underdiagnosing, replicating diagnostic tests and adverse drug-drug interactions, placing a high burden on healthcare costs. Healthcare systems and hospitals are in need of new care pathways to address the complexity of multimorbid AF patients and to reduce costs. The EHRA-PATHS consortium set out to address this need for change in management for multimorbid, elderly AF patients in Europe through the development of new care pathways. The aim of this study is to evaluate the current management of risk factors and comorbidities, and subsequently implement the newly developed care pathways and evaluate if these pathways lead to better management of risk factors and comorbidities in multimorbid, elderly AF patients, compared to current standard care.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Groningen, 네덜란드
- University Medical Center Groningen
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Newly diagnosed atrial fibrillation (paroxysmal, persistent or permanent)
- ≥65 years of age
- Willing and able to participate and to attend the scheduled follow-up visits.
Exclusion Criteria:
- Atrial fibrillation episode was due to a trigger (i.e. postoperative, infection, hyperthyroidism etc.)
- Life expectancy of less than 1 year
- Participation in another clinical study (registry studies not included)
- Severe cognitive impairment / dementia (defined based on MMSE and CDR scoring systems)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: New care program
The health care provider will use the EHRA-PATHS' newly developed care pathways to assess whether there is an indication for presence of risk factors and comorbidities. If this is the case, the care pathways will show possible next steps for confirming the presence of these risk factors and comorbidities. If confirmed, treatment according to the current guidelines should be initiated. Since this leads to an individualized management plan, procedures can differ between patients and will also depend on local processes. |
Newly developed care pathways integrated into a care-management software tool |
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간섭 없음: Routine clinical care
The health care provider follows current clinical practice with regards to history taking, physical examination etc. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Identification and management of risk factors and comorbidities
기간: 6 months
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The number of risk factors and comorbidities that are identified and for which treatment is initiated during base mapping and at the end of the randomized controlled trial. |
6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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AF symptom burden
기간: 6 months
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Measured with the Atrial Fibrillation Severity Scale (AFSS) questionnaire |
6 months
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Quality of life (QoL)
기간: 6 months
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Measured with the EuroQol five-dimensional five-level (EQ-5D-5L) questionnaire |
6 months
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Referrals to other disciplines
기간: 6 months
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The referrals to other disciplines will consist of the number of referrals and the percentage of patients referred. |
6 months
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Patient and health care provider satisfaction
기간: 6 months
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Measured with a patient and health care provider (HCP) satisfaction questionnaire |
6 months
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Healthcare resource use/costs
기간: 6 months
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Measured with the iMedical Consumption Questionnaire (iMCQ) |
6 months
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HRQoL/utility
기간: 6 months
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Measured with the EQ-5D-5L questionnaire (iMCQ) |
6 months
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공동 작업자 및 조사자
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 (실제)
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. .