Computer Tailored Program for Smoking Cessation Among Romanian Adults

Sponsor
Iuliu Hatieganu University of Medicine and Pharmacy (Other)
Overall Status
Unknown status
CT.gov ID
NCT02028962
Collaborator
(none)
640
1
2
13
49.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Lifestyle counseling
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
640 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Development, Implementation and Evaluation of a Computer Tailored Program for Smoking Cessation Among Romanian Adults
Study Start Date :
Oct 1, 2013
Anticipated Primary Completion Date :
Aug 1, 2014
Anticipated Study Completion Date :
Nov 1, 2014

Arms and Interventions

Arm Intervention/Treatment
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

No Intervention: Control

Outcome Measures

Primary Outcome Measures

  1. abstinence from smoking in the last 7 days [baseline and 6 months after]

Secondary Outcome Measures

  1. quiting attempts in the last 6 months [baseline and 6 months after]

  2. smoking related attitudes [baseline and six months after]

  3. self-eficacy in quiting smoking [baseline and 6 months after]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Iuliu Hatieganu University of Medicine and Pharmacy Cluj-Napoca Cluj Romania 400340

Sponsors and Collaborators

  • 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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Lucia Maria Lotrean, MD, PhD, Iuliu Hatieganu University of Medicine and Pharmacy
ClinicalTrials.gov Identifier:
NCT02028962
Other Study ID Numbers:
  • Renuntlafumat
First Posted:
Jan 7, 2014
Last Update Posted:
Jan 7, 2014
Last Verified:
Jan 1, 2014
Keywords provided by Lucia Maria Lotrean, MD, PhD, Iuliu Hatieganu University of Medicine and Pharmacy

Study Results

No Results Posted as of Jan 7, 2014