- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02028962
Computer Tailored Program for Smoking Cessation Among Romanian Adults
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 :
- ''diagnosis'' by means of questionnaires at the individual level of characteristics that are relevant for a person's smoking behavior
- development of the ''message library'' that contains all education messages that may be needed
- 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
- generating of personalized letters for each participant
- 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.
Studieöversikt
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Cluj
-
Cluj-Napoca, Cluj, Rumänien, 400340
- Rekrytering
- Iuliu Hatieganu University of Medicine and Pharmacy
-
Kontakt:
- Lucia M Lotrean, MD, PhD
- Telefonnummer: 0040724367460
- E-post: llotrean@umfcluj.ro
-
Huvudutredare:
- Lucia M Lotrean, MD, PhD
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Inget ingripande: Kontrollera
|
|
|
Experimentell: 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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
abstinence from smoking in the last 7 days
Tidsram: baseline and 6 months after
|
baseline and 6 months after
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
quiting attempts in the last 6 months
Tidsram: baseline and 6 months after
|
baseline and 6 months after
|
|
smoking related attitudes
Tidsram: baseline and six months after
|
baseline and six months after
|
|
self-eficacy in quiting smoking
Tidsram: baseline and 6 months after
|
baseline and 6 months after
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Lucia M Lotrean, MD, PhD, Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- Renuntlafumat
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