Tobacco Intensive Motivational and Estimate Risk

Sponsor

Hospital Universitario Reina Sofia de Cordoba (Other)

Overall Status

Completed

CT.gov ID

NCT03583203

Collaborator

Instituto de Salud Carlos III (Other)

230

Enrollment

Location

Arms

17.6

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Severe Mental Disorder Smoking Cessation COPD	Device: personalized information about lung damage	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

230 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jul 12, 2018

Actual Primary Completion Date :

Dec 1, 2018

Actual Study Completion Date :

Dec 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental Group This group will include personalized information about lung damage. After evaluating their COPD, the patients will be informed about its existence it so and staging. Depending on the damage found, the generation of motivation will focus on the different prevention methods. Likewise, after the motivation level is set, the patients will be offered the option of treatment and regular follow-up. The intervention will be strengthened by motivational messages, half of which are linked to the possibilities of preventing respiratory damage, sent to the patient's mobile phone via SMS during the 3 months after the face-to-face intervention. Patients without mobile phones will receive a call on their phone to convey the same messages.	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
No Intervention: Control Group The control intervention lasts 30 minutes and will be structured around the 5 A's technique (Ask, Advice, Assess, Assist and Arrange).

Arm

Intervention/Treatment

Experimental: Experimental Group

This group will include personalized information about lung damage. After evaluating their COPD, the patients will be informed about its existence it so and staging. Depending on the damage found, the generation of motivation will focus on the different prevention methods. Likewise, after the motivation level is set, the patients will be offered the option of treatment and regular follow-up. The intervention will be strengthened by motivational messages, half of which are linked to the possibilities of preventing respiratory damage, sent to the patient's mobile phone via SMS during the 3 months after the face-to-face intervention. Patients without mobile phones will receive a call on their phone to convey the same messages.

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

No Intervention: Control Group

The control intervention lasts 30 minutes and will be structured around the 5 A's technique (Ask, Advice, Assess, Assist and Arrange).

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fernando Sarramea Crespo	Cordoba		Spain	14004

Sponsors and Collaborators

Hospital Universitario Reina Sofia de Cordoba
Instituto de Salud Carlos III

Investigators

Principal Investigator: Fernando Sarramea Crespo, Phd, Hospital Universitario Reina Sofia Cordoba

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fernando Sarramea Crespo, Principal Investigator, Hospital Universitario Reina Sofia de Cordoba

ClinicalTrials.gov Identifier:

NCT03583203

Other Study ID Numbers:

PI16/0082

First Posted:

Jul 11, 2018

Last Update Posted:

Jan 9, 2020

Last Verified:

Jan 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Fernando Sarramea Crespo, Principal Investigator, Hospital Universitario Reina Sofia de Cordoba

Additional relevant MeSH terms:

Mental Disorders

Psychotic Disorders

Study Results

No Results Posted as of Jan 9, 2020