Effectiveness of Messages to Mobile Phone in Smoke Cessation

Not Applicable

Completed

• Conditions: Smoking

• Registration Number: NCT01746069
• Lead Sponsor: Basque Health Service

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-12-07
• Study First Submitted QC: 2012-12-07
• Study First Posted: 2012-12-10
• Study Start: 2013-03
• Primary Completion: 2015-03
• Status Verified: 2015-10
• Study Completion: 2015-10
• Last Update Submitted: 2015-10-20
• Last Update Posted: 2015-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 320

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Coximetry test (positive/negative)	at 6 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Health centre Lakuabizkarra; 🇪🇸 Vitoria-Gasteiz, Alava, Spain