Computer Tailored Program for Smoking Cessation Among Romanian Adults

Tobacco Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02028962
• Other study ID #: Renuntlafumat
• Status: Recruiting
• Phase: N/A
• First received: January 6, 2014
• Last updated: January 6, 2014
• Start date: October 2013
• Est. completion date: November 2014

Study information

• Verified date: January 2014
• Source: Iuliu Hatieganu University of Medicine and Pharmacy
• Contact: Lucia M Lotrean, MD, PhD
• Phone: 0040724367460
• Email: llotrean[@]umfcluj.ro
• Is FDA regulated: No
• Health authority: Romania: National Authority for Scientific Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 640
• Est. completion date: November 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Tobacco Smoking

Intervention

Behavioral:
• Lifestyle counseling

Locations

Country	Name	City	State
Romania	Iuliu Hatieganu University of Medicine and Pharmacy	Cluj-Napoca	Cluj

Sponsors (1)

Lead Sponsor	Collaborator
Iuliu Hatieganu University of Medicine and Pharmacy

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	abstinence from smoking in the last 7 days		baseline and 6 months after	No
Secondary	quiting attempts in the last 6 months		baseline and 6 months after	No
Secondary	smoking related attitudes		baseline and six months after	No
Secondary	self-eficacy in quiting smoking		baseline and 6 months after	No

External Links

•   Link