Effect of a Structured Comprehensive Intervention to Stimulate Self- Management and Improve Quality of Life in People With Chronic Obstructive Pulmonary Disease(COPD). A Randomised Clinical Trial.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Quality of life St. George´s Respiratory Questionnaire (SGRQ)
研究概览
简要总结
This study evaluates the effect of of a structured self-management intervention plan in patients with chronic obstructive pulmonary disease in primary care setting.Half of the participants will receive the self-management plan while the other half will receive usual care.
详细描述
Chronic Obstructive Pulmonary Disease (COPD) is a great magnitude public health problem with an associated increased mortality and a high cost (consumption of health care resources and loss of health related quality of life (HRQoL)). The comprehensive approach to this complex disease, focusing self-care promotion, improves HRQoL and the patients" clinical status, as shown by several studies, although further investigation is needed to confirm these results in the field of Primary Care (PC) and to formulate clear recommendations on the more effective type of intervention.
Hypothesis: In (moderate-severe) COPD patients, a structured self-management intervention plan in the setting of primary care, is more effective than usual treatment on the main outcomes associated with the disease: HRQoL, lung function, exacerbations and hospital admissions, at 6, 12 and 24 months of follow-up.
Objectives: To evaluate the impact of a comprehensive intervention plan to promote self-care and improve HRQoL in people with COPD in PC.
Methods: Multicenter randomized controlled trial, conducted at PC centers in Barcelona.
Determinations: Specific standardized and validated questionnaires, as the St George's Respiratory for the HRQoL. Statistical analysis: Intention to treat analysis. Descriptive statistics of the variables of the intervention and the control group to assess their homogeneity at the beginning of the study. An analysis of variance (ANOVA) will be used to assess differences among intervention groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with at least one visit at the primary care physician during the past year
- •Patients with a diagnosis of moderate (FEV1 50% - 80%) or severe (FEV1 30% - 50%) COPD
- •Patients treated with inhaled bronchodilators and accepting to participate in the study.
排除标准
- •Patients unable to come to the primary care centre
- •Patients with cognitive impairment and/or a severe mental condition.
- •Patients with a diagnosis of asthma, tuberculosis or other chronic respiratory disease.
- •Patients needing chronic oxygen therapy.
- •Patients with any terminal disease
结局指标
主要结局
Quality of life St. George´s Respiratory Questionnaire (SGRQ)
时间窗: Change from baseline at 6 ,12 and 24 months
St. George´s Respiratory Questionnaire (SGRQ).Disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Number of items: 50 items Number of domains \& categories : 2 parts (3 components). Part 1 : Symptoms component (frequency \& severity) with a 1, 3 or 12-month recall (best performance with 3- and 12-month recall); Part 2: Activities that cause or are limited by breathlessness; Impact components (social functioning, psychological disturbances resulting from airways disease) refer to current state as the recall. Scaling of items Part I (Symptoms): several scales; Part II (Activity and Impacts): dichotomous (true/false) except last question (4-point Likert scale). Scores range from 0 to 100, with higher scores indicating more limitations.
次要结局
- Number of COPD exacerbations(at 6 ,12 and 24 months from baseline)
- Intensity of symptoms related to COPD(Change from baseline at 6 ,12 and 24 months)
- Changes in the Body mass index, Obstruction, Dyspnea, Exacerbations Index (BODEx index )(Change from baseline at 6 ,12 and 24 months)
- Changes in forced vital capacity (FVC)(Change from baseline at 6 ,12 and 24 months)
- Use of long-acting beta-adrenergic bronchodilator in monotherapy(At baseline and at 6 ,12 and 24 months)
- Use of long-acting anticholinergic bronchodilator in monotherapy(At baseline and at 6 ,12 and 24 months)
- Use of a double therapy of long-acting beta-adrenergic bronchodilator and long-acting anticholinergic bronchodilator(At baseline and at 6 ,12 and 24 months)
- Use of a double therapy of long-acting beta-adrenergic bronchodilator and short-acting anticholinergic bronchodilator(At baseline and at 6 ,12 and 24 months)
- Use of Roflumilast(At baseline and at 6 ,12 and 24 months)
- Dyspnea score severity(Change from baseline at 6 ,12 and 24 months)
- Results of the Test of Adherence to Inhalers (TAI test)(Change from baseline at 6 ,12 and 24 months)
- Use of a triple therapy of long-acting beta-adrenergic bronchodilator and long-acting anticholinergic bronchodilator plus inhaled steroids(At baseline and at 6 ,12 and 24 months)
- Use of a triple therapy of long-acting beta-adrenergic bronchodilator and short-acting anticholinergic bronchodilator plus inhaled steroids(At baseline and at 6 ,12 and 24 months)
- Number of hospital admissions due to COPD exacerbation(at 6 ,12 and 24 months from baseline)
- Changes in Anxiety and depression scales(Change from baseline at 6 ,12 and 24 months)
- Changes in forced expiratory volume at the first second (FEV1)(Change from baseline at 6 ,12 and 24 months)