Effectiveness of Messages to Mobile Phone in Smoke Cessation

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of a Reinforcement Program Using Text Messages Through Mobile Phone in Smoking Cessation Programs in Primary Care

Conditions
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Smoking

Intervention / Treatment
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* Behavioral: Quit smoking combined cessation programme
* Behavioral: health advice


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Over 18 years. Current smoker (25): Current smoker is defined as the person who at the time of the study beginning declares that smoked daily or occasionally. Possessing mobile phone. Able to receive and send messages through mobile phone. Score greater than 5 or equal to 5 on the Richmond scale Exclusion criteria: People with a history of mental and behavioral disorders. Patients with a diagnosis of depression using the depression subscale of Goldberg (two or more positive responses). Patients who with pharmacological therapy for smoking cessation or who require it throughout the study. Pregnant women.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: health advice<br>clinical practice routine | Behavioral: health advice<br>* routine clinical practice<br>|
| Experimental: Quit smoking combined cessation programme<br>Health advice and support sms messages to patient's mobile phone + clinical routine practice | Behavioral: Quit smoking combined cessation programme<br>* Support sms messages to patient's mobile phone and health advice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coximetry test (positive/negative) |  | at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | at first week | 
| -Prevalence abstinence at the 4th week self-reported by the patient: Yes / No. |  | At 4th week | 
| -Prevalence abstinence at 12th week self-reported by the patient: Yes / No. |  | 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 | at 12 months | 
| Number of messages requested by the patient anxiety. |  | at 12 months | 
| slip: Yes / No. | Treated as the first use (consumption point) after a period of abstinence | 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. | At 12 months | 
| Number of messages relapse-slip timely requested by the patient. |  | At 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smoke cessation, quit smoke, smoking, sms