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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| health advice | Placebo Comparator | clinical practice routine |
|
| Quit smoking combined cessation programme | Experimental | Health advice and support sms messages to patient's mobile phone + clinical routine practice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quit smoking combined cessation programme | Behavioral | Support sms messages to patient's mobile phone and health advice |
|
| Measure | Description | Time Frame |
|---|---|---|
| Coximetry test (positive/negative) | at 6 months |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| other variables | 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). | at baseline |
Inclusion Criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health centre Lakuabizkarra | Vitoria-Gasteiz | Alava | 01009 | Spain |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 23, 2016 | |
| Reset | Feb 14, 2017 | |
| Release | Mar 13, 2020 | |
| Reset | Mar 25, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 23, 2016 | Feb 14, 2017 | |||
| Mar 13, 2020 |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D016540 | Smoking Cessation |
| D058496 | Smith-Magenis Syndrome |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D015438 | Health Behavior |
| D021081 | Chronobiology Disorders |
| D009422 | Nervous System Diseases |
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| health advice | Behavioral | routine clinical practice |
|
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 |
| Mar 25, 2020 |
| D000015 |
| Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D025063 | Chromosome Disorders |
| D030342 | Genetic Diseases, Inborn |