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临床试验/NCT02001922
NCT02001922已完成不适用

COPD Integrated Care Program Valais - Living Well With COPD, a Pilot Study Assessing Feasibility, Acceptability and Effectiveness in the Canton of Valais, Switzerland

Centre Hospitalier du Centre du Valais2 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2013年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
57
试验地点
2
主要终点
All-cause hospitalizations (past 12 months)

研究概览

简要总结

Background: Chronic obstructive pulmonary disease (COPD) is a progressive respiratory disorder characterized by acute exacerbations that contribute to physical impairment and increased healthcare use and costs. Given the increasing burden of this disease in terms of morbidity, disability, mortality and costs, innovative care models centered on patients and aiming at improving quality and comprehensiveness of care are needed. Effective implementation and evaluation of chronic disease management - integrated care(CDM-IC) programs, in the real world context is of great importance.

Aim of the pilot study: To conduct a pilot study assessing the acceptability, feasibility and effectiveness of a community-based CDM-IC program for COPD patients residing in the canton of Valais.

Design: The evaluation plan of this study will combine both quantitative (controlled before-after study design) and qualitative methods (focus groups with COPD patients and practicing healthcare professionals).

Setting: French-speaking part of the canton of Valais.

Patients: 50 adult (>35 years) COPD patients GOLD stage I (symptomatic) - IV of the disease, non-institutionalized and residing in the canton of Valais. The control group of patients will be constituted of age and gender-matched COPD patients from the Swiss COPD cohort study.

Measures:

Quantitative part:

Primary outcomes: Generic and disease-specific health-related quality-of-life and all-cause hospitalizations (past 12 months)

Other outcomes:

  1. Processes of care
  2. Patients' assessment of how care is congruent with the Chronic Care Model (PACIC instrument)
  3. Measure of self-efficacy (intermediary outcome)
  4. 6-minutes walking test, nb of COPD exacerbations, % of current smokers
  5. Healthcare utilization: unscheduled ambulatory care visits
  6. Care satisfaction
  7. Measures of the process of implementation of the intervention

Qualitative part: At 12 months: conduct of two focus groups of participating COPD patients, and of two focus groups of participating healthcare professionals.

详细描述

Background: Chronic obstructive pulmonary disease (COPD) is a progressive respiratory disorder characterized by acute exacerbations that contribute to physical impairment and increased healthcare use and costs. Given the increasing burden of this disease in terms of morbidity, disability, mortality and costs, innovative care models centered on patients and aiming at improving quality and comprehensiveness of care are needed. Effective implementation and evaluation of chronic disease management - integrated care(CDM-IC) programs, in the real world context is of great importance.

Aim of the pilot study: To conduct a pilot study assessing the acceptability, feasibility and effectiveness of a community-based CDM-IC program for COPD patients residing in the canton of Valais.

Design: The evaluation plan of this study will combine both quantitative and qualitative methods. A controlled before-after study design will be considered for the quantitative part of the project, and the qualitative part will include the conduct of focus groups with COPD patients and practicing healthcare professionals.

Setting: French-speaking part of the canton of Valais.

Patients: 50 adult (>35 years) COPD patients GOLD stage I (symptomatic) - IV of the disease, aged > 35 years, non-institutionalized and residing in the canton of Valais. Patients will be recruited by primary care and pulmonary care physicians practicing in the French-speaking part of the canton of Valais. The control group of patients will be constituted of age and gender-matched COPD patients already included in the Swiss COPD cohort study.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
35 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of COPD (GOLD stage 1-symptomatic to 4)
  • Age >= 35 years
  • Residing in the canton of Valais Switzerland, non-institutionalized
  • Informed consent

排除标准

  • Hospitalization during previous 4 weeks
  • Pulmonary rehabilitation during past 18 months
  • Estimated life expectancy < 12 months
  • Obvious cognitive impairment
  • Not speaking or understanding French well enough

结局指标

主要结局

All-cause hospitalizations (past 12 months)

时间窗: 12 months

Generic and disease-specific health-related quality-of-life (Chronic Respiratory Questionnaire (CRQ), SF-36, COPD Assessment Test (CAT))

时间窗: 12 months

次要结局

  • 6-minutes walking test(12 months)
  • Processes of care, patient assessment of chronic illness care (PACIC)(12 months)
  • COPD exacerbations(12 months)
  • % smokers(12 months)

研究者

发起方
Centre Hospitalier du Centre du Valais
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pierre-Olivier Bridevaux

Professor

Centre Hospitalier du Centre du Valais

研究点 (2)

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