NCT01520376已完成不适用
A Prospective Randomized Trial to Asses the Efficacy of an Early Psychiatric Counseling Compared to Usual Care in a Cohort of Patients Hospitalized for an Acute Exacerbation of COPD in Prevention of Re-exacerbation
Nestor Soler Porcar, MD, PhD2 个研究点 分布在 1 个国家目标入组 169 人开始时间: 2011年10月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 169
- 试验地点
- 2
- 主要终点
- Efficacy of the intervention
研究概览
简要总结
This study will try to elucidate wheter the impact of a psychiatric intervention in patients hospitalized because an acute exacerbation of COPD and anxiety/depression and reconsulting at 1 and 6 month after discharge.
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
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women of any ethnic group
- •Above 40 years old
- •Diagnose with Chronic Obstructive Pulmonary disease (COPD) according to the ATS/ERS guidelines
- •Acute exacerbation of COPD according to the following criteria:
- •a) Cyanosis b) Obnubilations or mental confusion d) Respiratory Rate above 25 per minute e) Failure of ambulatory treatment f) Co-morbidities that worsens respiratory condition g) Dyspnea
排除标准
- •Less than 6 months expectancy of life
- •Needing of mechanical ventilation
- •Severe cardiovascular disease
- •Pregnancy
- •Previous diagnosis of depression/anxiety
研究组 & 干预措施
Counselling
Active Comparator
People receiving a psychiatric evaluation after screening (HADS test > 12 points) and revised at 1 and 6 months
干预措施: Counselling (Behavioral)
Usual care
No Intervention
People after screening (HADS test > 12 points) and send to their primary care physician
结局指标
主要结局
Efficacy of the intervention
时间窗: 6 months
Counselling vs. usual care on re-hospitalizations
次要结局
- Impact of diagnosis(6 months)
研究者
Nestor Soler Porcar, MD, PhD
Especialista Sènior
Fundacion Clinic per a la Recerca Biomédica
研究点 (2)
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