- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00128765
Costs and Effects of Three Modes for Disease Management of Chronic Obstructive Pulmonary Disease in General Practice
Costs and Effects of Three Modes for Disease Management of Chronic Obstructive Pulmonary Disease (COPD) in General Practice. A Randomized Controlled Trial Comparing Regular Practice Nurse Review, Self-management Education and Usual Care
In this randomized controlled trial, three contemporary modes for chronic obstructive pulmonary disease (COPD) management in Dutch general practices are compared for costs and effects:
- usual general practitioner (GP) care (at patient's initiative);
- regular practice nurse review; and
- integrated self-management education.
All three interventions are based on existing guidelines, materials, and field experiences.
연구 개요
상태
정황
상세 설명
Considering the ageing of the Dutch population and the current and increasing shortage of general practitioners (GPs), the capacity of primary healthcare is a major and growing concern. Delegation of care normally provided by GPs with care provided by trained practice nurses is now rapidly emerging for patients with chronic respiratory disease, i.e. asthma and chronic obstructive pulmonary disease (COPD). However, most general practices still provide care at initiative of the patient self, because of the lack in scientific evidence and the costs of implementing a regular care structure. Self-care by patients may be an alternative to alleviate the growing load on primary health care.
The following two main research questions are addressed in this study.
- Does an integrated self-management education intervention for patients with COPD in general practice contribute to attaining long-term treatment targets, compared to regular monitoring by a practice nurse and usual GP care?
- What is the cost-effectiveness of an integrated self-management education intervention for patients with COPD, compared to regular monitoring by a practice nurse and usual GP care?
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
-
Nijmegen, 네덜란드, 6500 HB
- Radboud University, Department of General Medicine
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Registered in one of the general practices participating in the study
- Diagnosis of COPD, with Global Initiative for Chronic Obstructive Lung Diseases (GOLD) stage I, II or III
- Age ≥35 years
- Willing to provide written informed consent
Exclusion Criteria:
- Very poor prognosis with regard to respiratory condition (GOLD stage IV)
- Severe co-morbid conditions with a reduced life expectancy
- Unable to communicate in the Dutch language
- Objections to one or more of the disease management modes in the study
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
활성 비교기: usual care
usual care, i.e.
COPD care at patient's own initiative, mostly for medical help during exacerbations
|
care at initiative of the patient (usual GP care)
|
실험적: monitoring controls
regular COPD care (monitoring) provided by practice nurse according to current COPD guidelines
|
protocol based on existing Guidelines: Dutch College of General Practitioners (NHG) Global Initiative for Chronic Obstructive Lung Disease (GOLD)
|
실험적: self-management
disease specific self-management program 'Living Well with COPD'
|
disease specific self-management program 'Living Well with COPD', developed in Montreal, Canada
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
disease-specific health-related quality of life (HRQoL)
기간: two years
|
two years
|
2차 결과 측정
결과 측정 |
기간 |
---|---|
the number of exacerbations
기간: two years
|
two years
|
generic quality of life
기간: two years
|
two years
|
decline post- and pre-bronchodilator (BD) lung function indices
기간: two years
|
two years
|
level of respiratory symptoms
기간: two years
|
two years
|
satisfaction with the health care received
기간: two years
|
two years
|
compliance with (non-) pharmaceutical treatment
기간: two years
|
two years
|
direct and indirect medical costs
기간: two years
|
two years
|
COPD related self-efficacy
기간: two years
|
two years
|
COPD coping styles
기간: two years
|
two years
|
공동 작업자 및 조사자
협력자
수사관
- 연구 의자: Chris van Weel, FRCP, Department of General Practice, Radboud University, Nijmegen, The Netherlands
- 연구 책임자: Tjard Schermer, PhD, Department of General Practice, Radboud University, Nijmegen, The Netherlands
- 수석 연구원: Erik Bischoff, MD, Department of General Practice, Radboud University, Nijmegen, The Netherlands
간행물 및 유용한 링크
일반 간행물
- Bourbeau J, Julien M, Maltais F, Rouleau M, Beaupre A, Begin R, Renzi P, Nault D, Borycki E, Schwartzman K, Singh R, Collet JP; Chronic Obstructive Pulmonary Disease axis of the Respiratory Network Fonds de la Recherche en Sante du Quebec. Reduction of hospital utilization in patients with chronic obstructive pulmonary disease: a disease-specific self-management intervention. Arch Intern Med. 2003 Mar 10;163(5):585-91. doi: 10.1001/archinte.163.5.585.
- Monninkhof E, van der Valk P, van der Palen J, van Herwaarden C, Partridge MR, Zielhuis G. Self-management education for patients with chronic obstructive pulmonary disease: a systematic review. Thorax. 2003 May;58(5):394-8. doi: 10.1136/thorax.58.5.394.
- Bourbeau J, Nault D, Dang-Tan T. Self-management and behaviour modification in COPD. Patient Educ Couns. 2004 Mar;52(3):271-7. doi: 10.1016/S0738-3991(03)00102-2.
- Bischoff EW, Akkermans R, Bourbeau J, van Weel C, Vercoulen JH, Schermer TR. Comprehensive self management and routine monitoring in chronic obstructive pulmonary disease patients in general practice: randomised controlled trial. BMJ. 2012 Nov 28;345:e7642. doi: 10.1136/bmj.e7642.
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 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- MONC95582
- ZonMw grant: 945.04.230 (기타 보조금/기금 번호: ZonMw)
- Picasso grant: 005.2004 (기타 보조금/기금 번호: Picasso)
- CMO: 2004/249 (기타 식별자: Medical Ethics Committee)
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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