Clinical trial NCT01746069: Effectiveness of Messages to Mobile Phone in Smoke Cessation
Official title: Evaluation of a Reinforcement Program Using Text Messages Through Mobile Phone in Smoking Cessation Programs in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Keywords: smoking
smoke cessation
sms
quit smoke
Lead sponsor: Basque Health Service
Sponsor class: OTHER_GOV
First posted: 2012-12-10
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Coximetry test (positive/negative)
timeFrame: at 6 months
Secondary outcomes:
measure: Continuous abstinence at 6 months: Yes / No
timeFrame: At 6 months
measure: Abstinence point during the first 7 days self-reported by the patient: Yes / No.
timeFrame: at first week
measure: -Prevalence abstinence at the 4th week self-reported by the patient: Yes / No.
timeFrame: At 4th week
measure: -Prevalence abstinence at 12th week self-reported by the patient: Yes / No.
timeFrame: At 12th week
measure: -Outcome of coxymetry test at 12 months of start: Positive / Negative.
timeFrame: at 12 months
measure: Number of messages requested by the patient anxiety.
timeFrame: at 12 months
measure: slip: Yes / No.
timeFrame: at 12 months
measure: - Relapse: Yes / No.
timeFrame: At 12 months
measure: Number of messages relapse-slip timely requested by the patient.
timeFrame: At 12 months
Other outcomes:
measure: other variables
timeFrame: at baseline
Locations:
city: Vitoria-Gasteiz
country: Spain
facility: Health centre Lakuabizkarra
state: Alava
Study officials:
References: