Tobacco Intensive Motivational and Estimate Risk

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03583203
• Other study ID #: PI16/0082
• Status: Completed
• Phase: N/A
• Start date: July 12, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: January 2020
• Source: Hospital Universitario Reina Sofia de Cordoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: December 31, 2019
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• COPD
• Mental Disorders
• Psychotic Disorders
• Severe Mental Disorder
• Smoking Cessation

Intervention

Device:
• personalized information about lung damage
Chronic obstructive pulmonary disease (COPD) will be evaluated using spirometry. Based on this value, a motivational message about prevention will be issued for the intervention group, which will be reinforced by individualized text messages over a period of 3 months

Locations

Country	Name	City	State
Spain	Fernando Sarramea Crespo	Cordoba

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitario Reina Sofia de Cordoba	Instituto Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

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