Kingston COPD Cohort
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
Background: Chronic Obstructive Pulmonary (COPD) patients are the paradigm of the chronic complex patient. Their follow up can sometimes be difficult and challenging (1). There are patients with recurrent exacerbations that put an enormous burden on health care resources (2). They also have multiple comorbidities (3) that can sometimes make their management difficult. In an attempt to coordinate all these efforts KGH, HDH and Providence Care have numerous essential resources to take care of COPD patients like the nurse navigators, nurse practitioners and the pulmonary rehabilitation program. These programs provide an excellent support to the clinical activity of Respirologists and other health care providers.
Rationale: The main rationale for the development of the Kingston COPD cohort is to translate that highly demanding clinical activity in a teaching and research oriented activity that could be used by clinicians, medical students, residents and fellows. Having a guideline complained established protocol in COPD patients that are usually follow at KGH and HDH could help in not only in unified the way COPD patients are seeing (preserving the importance of the personalized approach) but most importantly established a multidimensional (clinical, physiological, radiological, laboratory) database. This could help know not only the results of our clinical activity but also have a long term (>5yrs) database for clinical research projects in collaboration with national and international research groups. Therefore this proposal is important because it will help translate our busy daily clinical work in a highly productive teaching and research activity.
详细描述
Aims: establish a long term multidimensional follow up of a large COPD cohort of COPD patients in Kingston, Ontario.
Specific Objectives: 1. established a simple and easy to apply follow up protocol in COPD patients. 2. Hire a research assistant 3. Set up the database.
Data source: Patients included in the present cohort will be those usually follow at the Respirology clinic at Hotel Dieu Hospital in Kingston Ontario.
Data elements: this will include clinical, laboratory, physiological and radiological data.
Clinical: baseline and yearly evaluation. The following information will be collected and registered: Age, gender, history of prematurity and low weight at birth, maternal smoking during pregnancy, history of infections or wheezing during infancy, pack year history: (age of smoking initiation, years smoking, packs per day, age of quitting if quit), active or former smokers, use of vaping or marihuana?, registration of Comorbidities using the Copd cOmorbidiTy indEx COTE index, use of medications: LABA, LAMA, dual, LABA/ICS, ICS, Roflumilast, Erithromycin, NAC, etc, use of O2 at home: lt/min and duration, CPAP and BiPAP and pressures, degree of dyspnea measure by the Medical Research Council scale, height, weight, Body Mass Index, Free Fat Mass Index determined by electrical bioimpedance, handgrip, abdominal and pelvic girth.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ages between 40-85 years old.
- •Smoking history of at least 10 pack year history
- •Active of former smokers
- •Diagnosis of COPD according to the GOLD definition (4): post bronchodilator spirometry FEV1/FVC ≤0.70, including those with other associated respiratory diseases like asthma, bronchiectasis, stable lung cancer or Interstitial Lung Disease.
- •Ability to perform all study procedures (complete pulmonary function tests, six minute walking test (6MWT) and chest computed tomography) and provide/sign informed consent.
排除标准
- •Patients not willing to sign the consent form
- •Patients with a life expectancy of less than 3 yrs.
- •Patients in palliative care.
- •Patients with chronic airway obstruction ie: FEV1/FVC≤0.70 of other etiology and without a smoking history of less than 10 packs year history.
- •Patients unable ort not able to perform the pulmonary function test, the 6MWT or the chest CT.
结局指标
主要结局
Mortality
时间窗: 10 years
Patients that will die during the follow up period
Exacerbations
时间窗: 10 years
Number of COPD exacerbations per year
次要结局
未报告次要终点
研究者
Dr. Juan Pablo de Torres Tajes
Professor
Queen's University