NCT01746069

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
320

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 10, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

October 21, 2015

Status Verified

October 1, 2015

Enrollment Period

2 years

First QC Date

December 7, 2012

Last Update Submit

October 20, 2015

Conditions

Smoking

Keywords

smokingsmoke cessationsmsquit smoke

Outcome Measures

Primary Outcomes (1)

  • Coximetry test (positive/negative)

    at 6 months

Secondary Outcomes (9)

  • Continuous abstinence at 6 months: Yes / No

    At 6 months

  • Abstinence point during the first 7 days self-reported by the patient: Yes / No.

    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.

    at 12 months

  • +4 more secondary outcomes

Other Outcomes (1)

  • other variables

    at baseline

Study Arms (2)

health advice

PLACEBO COMPARATOR

clinical practice routine

Behavioral: health advice

Quit smoking combined cessation programme

EXPERIMENTAL

Health advice and support sms messages to patient's mobile phone + clinical routine practice

Behavioral: Quit smoking combined cessation programme

Interventions

Quit smoking combined cessation programmeBEHAVIORAL

Support sms messages to patient's mobile phone and health advice

Quit smoking combined cessation programme
health adviceBEHAVIORAL

routine clinical practice

health advice

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health centre Lakuabizkarra

Vitoria-Gasteiz, Alava, 01009, Spain

Location

MeSH Terms

Conditions

SmokingSmoking CessationSmith-Magenis Syndrome

Condition Hierarchy (Ancestors)

BehaviorHealth BehaviorChronobiology DisordersNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, Inborn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
pharmaceutical

Study Record Dates

First Submitted

December 7, 2012

First Posted

December 10, 2012

Study Start

March 1, 2013

Primary Completion

March 1, 2015

Study Completion

October 1, 2015

Last Updated

October 21, 2015

Record last verified: 2015-10

Locations

ES(1)