Long - Term Respiratory Rehabilitation Programs in Chronic Obstructive Pulmonary Disease (COPD) Patients: Study of Cost- Effectiveness.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 116
- 试验地点
- 2
- 主要终点
- comparison of GR1 and GR2 costs;
研究概览
简要总结
OBJECTIVE: To determine whether a long-term maintenance program after respiratory rehabilitation, in contrast to the usual minimal maintenance therapy, improves the cost-effectiveness through: a.- maintaining long term effects in terms of effort capacity, HRQL, and reduced exacerbations b.- reducing the total cost of care to patients, largely through reduction of exacerbations.
MATERIAL AND METHODS: multi-center (4 hospitals) prospective randomized controlled study that will include 150 patients with moderate-severe COPD (age <75; BODE 4-10) with a 3 years follow-up. All patients will receive an initial in-hospital rehabilitation program which includes: Education, Physiotherapy, lower and upper extremities training and respiratory muscles training. Following completion of this program, patients will undergo concealed randomization to one of two maintenance strategies:1.-an intensive maintenance program (GR1) 2.- a standard, minimal monitoring program (GR2). On the intensive maintenance program (GR1) the physiotherapist will call once a week as a reminder and the patient will attend the hospital once a week . A physiotherapist will supervise the weekly in-hospital exercise and he/she will check if the patient is properly undergoing the rehabilitation treatment.
OUTCOMES: 1.- Clinical: dyspnea (area of CRQ questionnaire), HRQL (CRQ, SF 36); Effort capacity (6minute Walking Test), BODE index; 2.- Economical: direct costs (programs); indirect costs (exacerbations, admissions); comparison of GR1 and GR2 costs; EXPECTED OUTCOMES: reduction of dyspnea, improvement of HRQL, effort capacity and BODE index, and reduction of health expenditures in GR1 compared to GR2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 77 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COPD Patients
- •Less than 77 years
- •BODE index of 3-10 (BODE 3 when FEV1<50% v. Ref.).
- •clinically stable (at least one month)
- •Informed consent signed
排除标准
- •Bone or muscle disease that limits the exercise training.
- •Heart disease that disable physic exercise.
- •Bronchiectasis or other Respiratory diseases different than COPD.
- •Comorbidity that difficult o disable respiratory rehabilitation program carrying out.
- •Life expectation less than 2 years.
结局指标
主要结局
comparison of GR1 and GR2 costs;
时间窗: 1.5 Years
1.- Clinical: dyspnea (area of CRQ questionnaire),
时间窗: 1.5 YEARS
Effort capacity (6minute Walking Test),
时间窗: 1.5 Years
Economical: direct costs (programs);
时间窗: 1.5 Years
indirect costs (exacerbations, admissions);
时间窗: 1.5 Years
BODE index;
时间窗: 1.5 Years
次要结局
未报告次要终点
