- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03583203
Tobacco Intensive Motivational and Estimate Risk
January 7, 2020 updated by: Fernando Sarramea Crespo, Hospital Universitario Reina Sofia de Cordoba
Efficacy in Patients With Severe Mental Disorders of an Intensive Motivational Interventional Programme Offering Individualized Information on Respiratory Damage for Smoking Cessation
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
230
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Cordoba, Spain, 14004
- Fernando Sarramea Crespo
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
38 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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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
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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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Smoking cessation
Time Frame: 12 months
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Self-reported abstinence over the previous 7 days, confirmed by cooximetry with expired CO <10 ppm
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12 months
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COPD diagnosis
Time Frame: 12 month
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Presence of COPD and staging and percentage of forced expiratory volume at one second (FEV1) compared with expected level
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12 month
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Fernando Sarramea Crespo, Phd, Hospital Universitario Reina Sofia Cordoba
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 12, 2018
Primary Completion (Actual)
December 1, 2018
Study Completion (Actual)
December 31, 2019
Study Registration Dates
First Submitted
June 28, 2018
First Submitted That Met QC Criteria
June 28, 2018
First Posted (Actual)
July 11, 2018
Study Record Updates
Last Update Posted (Actual)
January 9, 2020
Last Update Submitted That Met QC Criteria
January 7, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI16/0082
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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