Effectiveness of Messages to Mobile Phone in Smoke Cessation

Smoking Clinical Trial

Official title:

Evaluation of a Reinforcement Program Using Text Messages Through Mobile Phone in Smoking Cessation Programs in Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01746069
• Other study ID #: TAB-01
• Status: Completed
• Phase: N/A
• First received: December 7, 2012
• Last updated: October 20, 2015
• Start date: March 2013
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: Basque Health Service
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: October 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Smoking

Intervention

Behavioral:
• Quit smoking combined cessation programme
Support sms messages to patient's mobile phone and health advice
• health advice
routine clinical practice

Locations

Country	Name	City	State
Spain	Health centre Lakuabizkarra	Vitoria-Gasteiz	Alava

Sponsors (1)

Lead Sponsor	Collaborator
Basque Health Service

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Coximetry test (positive/negative)		at 6 months
Secondary	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
Secondary	Abstinence point during the first 7 days self-reported by the patient: Yes / No.	Abstinence is defined as not smoking anything punctual during the last seven days.	at first week
Secondary	-Prevalence abstinence at the 4th week self-reported by the patient: Yes / No.		At 4th week
Secondary	-Prevalence abstinence at 12th week self-reported by the patient: Yes / No.		At 12th week
Secondary	-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
Secondary	Number of messages requested by the patient anxiety.		at 12 months
Secondary	slip: Yes / No.	Treated as the first use (consumption point) after a period of abstinence	at 12 months
Secondary	- 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
Secondary	Number of messages relapse-slip timely requested by the patient.		At 12 months