Computer Tailored Program for Smoking Cessation Among Romanian Adults

January 6, 2014 updated by: Lucia Maria Lotrean, Iuliu Hatieganu University of Medicine and Pharmacy

Development, Implementation and Evaluation of a Computer Tailored Program for Smoking Cessation Among Romanian Adults

The research aim is the development, implementation and evaluation of the first computer tailored smoking cessation progam for Romanian adult smokers. It will be implemented among smokers from Romania aged 20-60 years. The participants will beneficiate of tailored information received in letters generated by using sophisticated computer algorithms, allowing the creation of highly individualized messages that address each individual's unique needs, motivations and beliefs related to smoking .

Program implementation will comprise of :

  1. ''diagnosis'' by means of questionnaires at the individual level of characteristics that are relevant for a person's smoking behavior
  2. development of the ''message library'' that contains all education messages that may be needed
  3. development of an ''algorithm'', a set of decision rules that evaluates the diagnosis, selects and generates messages tailored to the specific needs of the individual user
  4. generating of personalized letters for each participant
  5. sending of theses personalized letters to the participants. The participants will receive three personalized letters during a period of six months after registration into the program.

The effects of the program will be evaluated with a randomized controlled trial which will assess the changes in smoking behaviour as well as smoking related attitudes, self-efficacy and quiting attempts at 6 months after the enrolment into the program.

A process evaluation will assess participants' opinion about the program.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

640

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400340
        • Recruiting
        • Iuliu Hatieganu University of Medicine and Pharmacy
        • Contact:
        • Principal Investigator:
          • Lucia M Lotrean, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • smokers (smoked in the last 7 days)who intend to quit smoking in the next 6 months

Exclusion Criteria:

  • non-smokers
  • smokers who do not intend to quit smoking in the next 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: Lifestyle counseling
The experimental group will receive three letters with advices for smoking cessation-the first letter after the enrolment in the study, the second one one month after the first letter, the third one three months after the first letter
Behavioral: Lifestyle counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
abstinence from smoking in the last 7 days
Time Frame: baseline and 6 months after
baseline and 6 months after

Secondary Outcome Measures

Outcome Measure
Time Frame
quiting attempts in the last 6 months
Time Frame: baseline and 6 months after
baseline and 6 months after
smoking related attitudes
Time Frame: baseline and six months after
baseline and six months after
self-eficacy in quiting smoking
Time Frame: baseline and 6 months after
baseline and 6 months after

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Iuliu Hatieganu University of Medicine and Pharmacy

Investigators

  • Principal Investigator: Lucia M Lotrean, MD, PhD, Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Anticipated)

August 1, 2014

Study Completion (Anticipated)

November 1, 2014

Study Registration Dates

First Submitted

January 6, 2014

First Submitted That Met QC Criteria

January 6, 2014

First Posted (Estimate)

January 7, 2014

Study Record Updates

Last Update Posted (Estimate)

January 7, 2014

Last Update Submitted That Met QC Criteria

January 6, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Renuntlafumat

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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