Smoking
Conditions
Keywords
smoking, smoke cessation, sms, quit smoke
Brief summary
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.
Interventions
BEHAVIORALQuit smoking combined cessation programme
Support sms messages to patient's mobile phone and health advice
BEHAVIORALhealth advice
routine clinical practice
Sponsors
Basque Health Service
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Coximetry test (positive/negative) | at 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Continuous abstinence at 6 months: Yes / No | At 6 months | Continuous Abstinence is defined as smoking more than 5 cigarettes since the beginning of the follow-up period self-reported by the patient. |
| Abstinence point during the first 7 days self-reported by the patient: Yes / No. | at first week | Abstinence is defined as not smoking anything punctual during the last seven days. |
| -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 | — |
| Number of messages requested by the patient anxiety. | at 12 months | — |
| slip: Yes / No. | at 12 months | Treated as the first use (consumption point) after a period of abstinence |
| - Relapse: Yes / No. | At 12 months | Relapse is defined to return dependent behavior that had tried to change, recovering or not the baseline levels before treatment. |
| Number of messages relapse-slip timely requested by the patient. | At 12 months | — |
| -Outcome of coxymetry test at 12 months of start: Positive / Negative. | at 12 months | Only in patients with a negative result in the 6 months test |
Other
| Measure | Time frame | Description |
|---|---|---|
| other variables | at baseline | Sex (male / female), age (years), number of cigarettes per day before starting program, age of start smoking (years), smoke related pathology (Yes/No), score on the anxiety scale Goldberg, previous attempts to quit smoking (Yes / No if yes, specify number of attempts and reasons for relapse), ), smoking dependence fagerström test score), type of smoker (occasional / daily). |
Countries
Spain
Outcome results
None listed