CompletedNot Applicable

Effectiveness of Messages to Mobile Phone in Smoke Cessation

Spain320 participantsStarted 2013-03

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Coximetry test (positive/negative)

Timeframe: at 6 months

Trial details

NCT IDNCT01746069

SponsorBasque Health Service

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2015-03

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