NCT02028962

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. 1.''diagnosis'' by means of questionnaires at the individual level of characteristics that are relevant for a person's smoking behavior
  2. 2.development of the ''message library'' that contains all education messages that may be needed
  3. 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. 4.generating of personalized letters for each participant
  5. 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
640

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

October 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 7, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

January 7, 2014

Status Verified

January 1, 2014

Enrollment Period

10 months

First QC Date

January 6, 2014

Last Update Submit

January 6, 2014

Conditions

Tobacco Smoking

Keywords

Smoking cessationRomanian adults

Outcome Measures

Primary Outcomes (1)

  • abstinence from smoking in the last 7 days

    baseline and 6 months after

Secondary Outcomes (3)

  • quiting attempts in the last 6 months

    baseline and 6 months after

  • smoking related attitudes

    baseline and six months after

  • self-eficacy in quiting smoking

    baseline and 6 months after

Study Arms (2)

Lifestyle counseling

EXPERIMENTAL

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

Control

NO INTERVENTION

Interventions

Lifestyle counselingBEHAVIORAL
Lifestyle counseling

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Iuliu Hatieganu University of Medicine and Pharmacy

Cluj-Napoca, Cluj, 400340, Romania

RECRUITING

Related Links

MeSH Terms

Conditions

Tobacco SmokingSmoking Cessation

Condition Hierarchy (Ancestors)

SmokingBehaviorTobacco UseHealth Behavior

Study Officials

  • Lucia M Lotrean, MD, PhD

    Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucia M Lotrean, MD, PhD

CONTACT

0040724367460llotrean@umfcluj.ro

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

January 6, 2014

First Posted

January 7, 2014

Study Start

October 1, 2013

Primary Completion

August 1, 2014

Study Completion

November 1, 2014

Last Updated

January 7, 2014

Record last verified: 2014-01

Locations

RO(1)