Smoking remains a major risk factor for chronic diseases and is a real problem for health systems. The use of emerging technologies, such as mobile phone , may have a important role in smoking cessation programs through sending reinforcement messages when patients quits smoking. Main objective: To evaluate the effectiveness of a combined 6 months smoking cessation program including health advice provided by a doctor and sending support messages to mobile phone of patients. Methods: Study design: Randomized single blind clinical trial. Study population: Patients over 18 who are willing to start a smoking cessation program, who have mobile phone, who are able to receive and send messages, and who have a score greater than 5 or equal to 5 on the Richmond scale. Sample size: 160 patients per arm to detect a difference in the percentage of smoking cessation than 10% (14.9% vs. 4.9%) between the two groups. Intervention: Experimental group: Health advice and support messages to mobile phone patients. Control group: Health advice. Assessment of the primary endpoint: At 6 months (positive/negative coximetry test). Statistical analysis: The analysis of the primary endpoint (positive / negative coximetry test) will be performed using logistic regression.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
320
Support sms messages to patient's mobile phone and health advice
routine clinical practice
Health centre Lakuabizkarra
Vitoria-Gasteiz, Alava, Spain
Coximetry test (positive/negative)
Time frame: at 6 months
Continuous abstinence at 6 months: Yes / No
Continuous Abstinence is defined as smoking more than 5 cigarettes since the beginning of the follow-up period self-reported by the patient.
Time frame: At 6 months
Abstinence point during the first 7 days self-reported by the patient: Yes / No.
Abstinence is defined as not smoking anything punctual during the last seven days.
Time frame: at first week
-Prevalence abstinence at the 4th week self-reported by the patient: Yes / No.
Time frame: At 4th week
-Prevalence abstinence at 12th week self-reported by the patient: Yes / No.
Time frame: At 12th week
-Outcome of coxymetry test at 12 months of start: Positive / Negative.
Only in patients with a negative result in the 6 months test
Time frame: at 12 months
Number of messages requested by the patient anxiety.
Time frame: at 12 months
slip: Yes / No.
Treated as the first use (consumption point) after a period of abstinence
Time frame: at 12 months
- Relapse: Yes / No.
Relapse is defined to return dependent behavior that had tried to change, recovering or not the baseline levels before treatment.
Time frame: At 12 months
Number of messages relapse-slip timely requested by the patient.
Time frame: At 12 months
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