Preventing Repeat Hospitalisations in Patients With Chronic Obstructive Pulmonary Disease (COPD) (INCA R-ACE)
2019년 7월 17일 업데이트: Professor Richard Costello, Beaumont Hospital
Risk Factors for Re-exacerbation After a Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
The purpose of this study is to determine whether the investigators can predict which patients are at risk of a re-exacerbation of COPD within 30 and 90 days using changes in lung capacity during the initial exacerbation.
연구 개요
상태
완전한
상세 설명
Patients admitted to hospital with an acute exacerbation of COPD will be approached to participate in the study.
The investigators will analyse changes in lung capacity (through measurement of spirometry and inspiratory capacity) and physical activity level over the first three days of admission, at discharge and at a day 30 follow-up visit. The investigators will record quality of life and symptom scores at these time points and again at a day 90 telephone visit. Data relating to the patients overall health status -disease severity, co-morbidity, cognition, psychological status, home environment and adherence to inhaled medication will be collected. The investigators will look for any relationship between these changes and a further exacerbations within 30 and 90 days.
The central hypothesis of this proposal is that the clinical course following an exacerbation of COPD may be monitored through measurement of inspiratory capacity(IC), a marker of lung hyperinflation. Resolution of an exacerbation is related to an increase in inspiratory capacity above a threshold level of improvement, after which the risk of re-exacerbation within the subsequent 30 and 90 days is low. The investigators will assess the accuracy of IC as a predictor of exacerbation and the feasibility of measuring IC during the early stages of a COPD exacerbation.
연구 유형
관찰
등록 (실제)
207
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Dublin, 아일랜드
- Beaumont Hospital
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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
35년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
샘플링 방법
비확률 샘플
연구 인구
Patients admitted to hospital with an acute exacerbation of COPD
설명
Inclusion Criteria:
- Within 72 hours of admission with an Acute Exacerbation of COPD (AE COPD) defined as "an acute change in a patient's baseline dyspnoea, cough and/or sputum beyond day-to-day variability sufficient to warrant a change in therapy" as per ATS/ERS consensus guidelines[ ] where "a change in therapy" includes the following: Prescription of antibiotics and / or systemic steroids
- Diagnosis of COPD based on GOLD criteria
- Able to give informed consent
- Willing to participate in the study
Exclusion Criteria:
- Admission reason other than AE COPD or breathlessness primarily caused by another pathology
- Already enrolled in the study
- Receiving palliative care
- Severe cognitive impairment or psychological disorder that results in inability to give informed consent or complete investigations required for the study
- Physical impairment resulting in inability to complete physiological tests
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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The relationship between change in inspiratory capacity(IC), from admission with an exacerbation of COPD to hospital discharge, and the risk of 30-day and 90-day re-exacerbation is reduced.
기간: From admission to 90 days from hospitalisation with an exacerbation
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From admission to 90 days from hospitalisation with an exacerbation
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Relationship between changes in IC and respiratory symptoms
기간: From admission to 30 days from hospitalisation with an exacerbation
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Medical Research Council(MRC) and Borg breathlessness scores and IC will be measured at hospitalisation with an exacerbation of COPD and at 30 days post exacerbation and correlated.
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From admission to 30 days from hospitalisation with an exacerbation
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Relationship between changes in Forced Expiratory Volume in 1 second (FEV1) and respiratory symptoms
기간: From admission to 30 days from hospitalisation with an exacerbation
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Medical Research Council(MRC) and Borg breathlessness scores and FEV1 will be measured at hospitalisation with an exacerbation of COPD and at 30 days post exacerbation and correlated.
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From admission to 30 days from hospitalisation with an exacerbation
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Relationship between changes in Forced Vital Capacity and respiratory symptoms
기간: From admission to 30 days from hospitalisation with an exacerbation
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Medical Research Council(MRC) and Borg breathlessness scores and FVC will be measured at hospitalisation with an exacerbation of COPD and at 30 days post exacerbation and correlated.
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From admission to 30 days from hospitalisation with an exacerbation
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Relationship between change in IC and quality of life scores
기간: From admission to 30 days from hospitalisation with an exacerbation
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COPD Assessment Test (CAT) quality of life score and IC will be measured at hospitalisation with an exacerbation of COPD and at 30 days post exacerbation and correlated.
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From admission to 30 days from hospitalisation with an exacerbation
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Relationship between change in FEV1 and quality of life scores
기간: From admission to 30 days from hospitalisation with an exacerbation
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COPD Assessment Test (CAT) quality of life score and FEV1 will be measured at hospitalisation with an exacerbation of COPD and at 30 days post exacerbation and correlated.
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From admission to 30 days from hospitalisation with an exacerbation
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Relationship between change in FVC and quality of life scores
기간: From admission to 30 days from hospitalisation with an exacerbation
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COPD Assessment Test (CAT) quality of life score and FVC will be measured at hospitalisation with an exacerbation of COPD and at 30 days post exacerbation and correlated.
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From admission to 30 days from hospitalisation with an exacerbation
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Relationship between change in IC and gait speed
기간: From admission to 30 days from hospitalisation with an exacerbation
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4 metre gait speed test and IC will be measured at hospitalisation with an exacerbation of COPD and at 30 days post exacerbation and correlated.
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From admission to 30 days from hospitalisation with an exacerbation
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Relationship between change in FEV1 and gait speed
기간: From admission to 30 days from hospitalisation with an exacerbation
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4 metre gait speed test and FEV1 will be measured will be measured at hospitalisation with an exacerbation of COPD and at 30 days post exacerbation and correlated.
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From admission to 30 days from hospitalisation with an exacerbation
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Relationship between change in FVC and gait speed
기간: From admission to 30 days from hospitalisation with an exacerbation
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4 metre gait speed test and FVC will be measured at hospitalisation with an exacerbation of COPD and at 30 days post exacerbation and correlated.
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From admission to 30 days from hospitalisation with an exacerbation
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Relationship between patient factors and subsequent exacerbation
기간: 90 days from hospitalisation with an exacerbation
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The association between patient factors (to include baseline GOLD grade, Charlston co-morbidity index score, Katz index, Hospital Anxiety and Depression Scale (HADS) score, Montreal Cognitive Assessment (MOCA) score) and exacerbation in the entire cohort and in those who do and do not achieve a rise in IC compared to baseline values will be examined
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90 days from hospitalisation with an exacerbation
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Time to re-exacerbation
기간: 90 days from hospitalisation with an exacerbation
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90 days from hospitalisation with an exacerbation
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Sensitivity of vital capacity measures taken with a bedside portable spirometer compared with those performed in the pulmonary function test laboratory
기간: Day 3-7 of hospital admission
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Vital capacity will be measured at the bedside with a portable spirometer and using gold standard spirometry in a pulmonary function laboratory.
These two measurements will then be compared and correlated.
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Day 3-7 of hospital admission
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Sensitivity of FEV1 measures taken with a bedside portable spirometer compared with those performed in the pulmonary function test laboratory
기간: Day 3-7 of hospital admission
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FEV1 will be measured at the bedside with a portable spirometer and using gold standard spirometry in a pulmonary function laboratory.
These two measurements will then be compared and correlated.
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Day 3-7 of hospital admission
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Sensitivity of inspiratory capacity (IC) measured with a bedside portable spirometer and by the gold standard body plethysmography
기간: Day 3-7 of hospital admission
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IC will be measured at the bedside with a portable spirometer and by gold standard body plethysmography in a pulmonary function laboratory.
These two measurements will then be compared and correlated.
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Day 3-7 of hospital admission
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Change in vital capacity during an exacerbation and its relationship to re-exacerbation
기간: At days 1-3 of admission, hospital discharge and 30 days from hospitalisation with an exacerbation
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At days 1-3 of admission, hospital discharge and 30 days from hospitalisation with an exacerbation
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Change in FEV1 during an exacerbation and its relationship to re-exacerbation
기간: At days 1-3 of admission, hospital discharge and 30 days from hospitalisation with an exacerbation
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At days 1-3 of admission, hospital discharge and 30 days from hospitalisation with an exacerbation
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Relationship between Exacerbation factors and re-exacerbation
기간: 90 days from hospitalisation with an exacerbation
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The association between exacerbation severity as determined by DECAF score, need for non-invasive ventilation or critical care, length of hospital stay in the entire cohort and in those who do and do not achieve a rise in IC compared to baseline values will be examined
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90 days from hospitalisation with an exacerbation
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Relationship between Social and Environmental factors and subsequent exacerbation
기간: 90 days from hospitalisation with an exacerbation
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The impact of patients social environment as determined by living conditions, presence of home supports, socioeconomic group in the entire cohort and in those who do and do not achieve a rise in IC compared to baseline values will be examined
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90 days from hospitalisation with an exacerbation
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Richard W Costello, Beaumont Hospital, Dublin, Ireland
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)
2015년 10월 1일
기본 완료 (실제)
2017년 7월 1일
연구 완료 (실제)
2018년 9월 1일
연구 등록 날짜
최초 제출
2015년 12월 10일
QC 기준을 충족하는 최초 제출
2015년 12월 30일
처음 게시됨 (추정)
2016년 1월 1일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 7월 18일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 7월 17일
마지막으로 확인됨
2019년 7월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- INCA-R-ACE
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