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临床试验/NCT03583203
NCT03583203已完成不适用

Efficacy in Patients With Severe Mental Disorders of an Intensive Motivational Interventional Programme Offering Individualized Information on Respiratory Damage for Smoking Cessation

Hospital Universitario Reina Sofia de Cordoba2 个研究点 分布在 1 个国家目标入组 230 人开始时间: 2018年7月12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
230
试验地点
2
主要终点
COPD diagnosis

研究概览

简要总结

Randomized, open label, prospective study with a 12-month follow-up period. The primary objective evaluates the effectiveness of an intensive anti-smoking programme that informs patients of their individual risk of lung damages and the possibilities of prevention. The main measurement will be having given up smoking in month 12, measurement of self-reported abstinence on the 7 previous days and confirmed by a CO-oximeter test< 10 ppm, between the intervention and control group. A total of 9 urban and rural mental health centres will participate in the study. The intervention group will undergo spirometry and presence and the degree of respiratory obstruction will be assessed. Participants will be given individual information to generate a motivational message about the possibilities of prevention and the information will be maintained for three months by sending text messages (SMS) to their mobile phones. The efficacy of the method and the pulmonary damage variables will be evaluated: smoking cessation at the end of follow-up will be confirmed by cooximetry, and the COPD diagnosis and the severity of the staging for disease will be assessed

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged between 40 and 70
  • Confirmed diagnosis of Bipolar Disorder or Schizophrenia according to Diagnostic and Statistical Manual of Mental Disorder IV (DSM-IV-TR)
  • Active smokers who currently consume at least 10 cigarettes a day, with a cumulative consumption of 10 packets/year or more.

排除标准

  • Previous respiratory diagnosis of: asthma, cystic fibrosis, tuberculosis, simple chronic bronchitis, restrictive pulmonary disease or bronchiectasis
  • Acute respiratory symptoms
  • Heart disease or advanced oncological processes
  • Existence of a pathology which makes it advisable not to perform spirometry (recent pneumothorax, recent thoracic or abdominal surgery, aortic aneurysm, unstable angulation, retinal detachment, facial hemiparesis or oral/dental problems)
  • Patients who, due to their intellectual disability or mental pathology, do not understand or cannot be forced to perform spirometry
  • Clinical instability with results of over 14 points on the Hamilton Depression Rating Scale (HDRS), a Young Mania Rating Scale (YMRS) of over 6 or a Positive and Negative Syndrome Scale (PANSS) of over 70

结局指标

主要结局

COPD diagnosis

时间窗: 12 month

Presence of COPD and staging and percentage of forced expiratory volume at one second (FEV1) compared with expected level

Smoking cessation

时间窗: 12 months

Self-reported abstinence over the previous 7 days, confirmed by cooximetry with expired CO \<10 ppm

次要结局

未报告次要终点

研究者

发起方
Hospital Universitario Reina Sofia de Cordoba
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Fernando Sarramea Crespo

Principal Investigator

Hospital Universitario Reina Sofia de Cordoba

研究点 (2)

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