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临床试验/NCT01090999
NCT01090999已完成不适用

Long - Term Respiratory Rehabilitation Programs in Chronic Obstructive Pulmonary Disease (COPD) Patients: Study of Cost- Effectiveness.

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau2 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2006年10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
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

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

研究者

发起方
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
申办方类型
Other
责任方
Sponsor

研究点 (2)

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