Tobacco Intensive Motivational and Estimate Risk

Not Applicable

Completed

• Conditions: Severe Mental Disorder; Smoking Cessation; COPD

• Registration Number: NCT03583203
• Lead Sponsor: Hospital Universitario Reina Sofia de Cordoba

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-28
• Study First Submitted QC: 2018-06-28
• Study First Posted: 2018-07-11
• Study Start: 2018-07-12
• Primary Completion: 2018-12-01
• Study Completion: 2019-12-31
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-07
• Last Update Posted: 2020-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
COPD diagnosis	12 month	Presence of COPD and staging and percentage of forced expiratory volume at one second (FEV1) compared with expected level
Smoking cessation	12 months	Self-reported abstinence over the previous 7 days, confirmed by cooximetry with expired CO \<10 ppm

Trial Locations

Locations (1)

Fernando Sarramea Crespo; 🇪🇸 Cordoba, Spain