A Comprehensive Care Programme for Patients With Chronic Obstructive Pulmonary Disease
연구 개요
상세 설명
Design: A randomised controlled trial of patients discharged from hospital after an episode of acute exacerbation of COPD. Patients will be randomised to the intervention arm or usual care group.
Setting: Tertiary University affiliated Hospital.
Interventions:
The Intervention group will receive a comprehensive programme which involves inputs from doctors, respiratory nurses and physiotherapists, providing an individualized care plan for each subject. The components in the programme will include optimization of medications, specialist physician follow up, nursing support in education, and physiotherapist support for pulmonary rehabilitation. Patients in the intervention group will also receive monthly telephone calls by a respiratory nurse for a period of 1 year to assess their conditions and answer their queries. Patients will also be followed up in the respiratory clinic by respiratory specialist once every 3 months for 1 year.
The control group will be managed as the usual care. The discharging physician will determine the patients' medication and follow up as in normal practice.
All patients will be asked to return for assessments (spirometry, 6 minute walk test, questionnaires on the severity of dyspnoea and quality of life) at baseline and 12 months
Main outcome measures: The primary endpoint is the hospital readmission rate and the secondary endpoints are the quality of life, mortality, lung function and exercise capacity of the patients.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Hong Kong, 홍콩
- The Chinese University of Hong Kong
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients who are admitted to the Prince of Wales Hospital with AECOPD will be screened for this study.
- Patients with age over 40 years
Exclusion Criteria:
- Patients with asthma
- Patients unable to provide informed consent
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: comprehensive care programme
Comprehensive care involving multidisciplinary input.
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Intervention group:
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간섭 없음: Control group
Control arm with usual care
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Hospital Readmission
기간: 12 months
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To investigate the effectiveness of a comprehensive care programme in reducing hospital admission in COPD patients who have been discharged from hospital for an episode of AECOPD.
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12 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Quality of Life
기간: 12 months
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Measured by change in St. George Respiratory Questionnaire (SGRQ) total score from baseline to 12 month.
SGRQ total score ranged from 0-100.
The change was calculated by the 12 month SGRQ total score minus the baseline value.
Negative values indicated improvement in quality of life.
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12 months
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Mortality
기간: 12 months
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From contacting the patient/their family and hospital record retrieval.
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12 months
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Lung Function
기간: 12 months
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Measurement of change of spirometry (FEV1 % predicted) from baseline to 12 month.
The range is from 0% to 100%.
The change was calculated by 12 month value minus the baseline value.
Positive value indicated improvement in lung function.
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12 months
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Exercise Capacity
기간: 12 month
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Exercise capacity was measured by change in 6 minutes walk test distance from baseline to 12 month.
6 minute walk test is the distance that the patient can walk over 6 minutes and it can range to 0 meters to few hundred meters.
This was calculated by the 12 month 6 minutes walk test distance minus that of the baseline.
Positive values indicated improvement in exercise capacity.
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12 month
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공동 작업자 및 조사자
수사관
- 연구 책임자: David S Hui, MD, Chinese University of Hong Kong
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
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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