Preference-based Tools for Smoking Cessation Among Disadvantaged Smokers, a Pragmatic Randomised Controlled Trial
A legfontosabb adatok
- Ki végzi
- Société de Formation Thérapeutique du Généraliste - Recherche
- Hol
- Franciaország15 helyszín, 1 országbanVálassz országot a helyszínekhez
- Azonosító
- Állapot
- Befejeződött
- Résztvevők
- 167 fő vett részt
- Kezdés
- 2021. febr. 26.
- Befejezés
- 2024. aug. 30.
- A vizsgálat típusa
- Beavatkozással járó, 2 csoportAz egyik csoport egy már használt kezelést kap, összehasonlításként.
- A vizsgált kezelések
- The STOP intervention
- Standard Care
- A regiszteradat frissítve
- 2024. december 16.
Ki vehet részt
- Életkor
- 18 év felett
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Részt vehetnek
A regiszter feltételei, szó szerint
Mind a 10 feltétel megnézéseKevesebb
Ki vehet részt
- Daily smokers (5≥ cigarettes/day)
- A low socio-economic position (meaning being unemployed or being a recipient of one of the state programs for low income individuals)
- Being available for at least 4 appointments over a 6 month period
- Affiliation to or benefiting from social security or state medical support
Ki nem vehet részt
- Individuals who do not speak French, or who have cognitive impairments making it impossible to understand study information or a condition that makes it impossible for them to give informed consent
- Major citizens protected by law, adults unable to express their consent and subject to a protective measure (guardianship, curatorship, safeguard of justice)
- Pregnant women or with a pregnancy project, mothers breastfeeding their child(ren)
- Regular smokers who vape daily (at least once a day)
- People who at the time of inclusion are already being managed for smoking cessation (whatever treatment: varenicline, electronic cigarette, NRT, hypnosis, acupuncture, psychotherapy, talk groups, etc.)
- Patients who are already participating in another clinical study (self-reported)
Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.
Egy országban van helyszíne. Válassz országot, hogy lásd a helyszíneket.
A vizsgálatról
Mit akar kideríteni a vizsgálat
- Objective:
A teljes eredeti leírásKevesebb
Our study aims to evaluate the effectiveness of the "STOP" (Sevrage Tabagique à l'aide d'Outils dédiés selon la Préférence: Smoking Cessation using preference-based tools) intervention, a preference-based smoking cessation intervention for smokers with low socio-economic position (SEP).
- Methods :
STOP is a randomised, multi-centre, single blinded, intent-to-treat trial. Participating centres include primary care practices (community, municipal or general health clinics), hospital-based facilities, and healthcare institutions specialised in addiction treatment. Smokers with low SEP will be randomised into either the intervention or control group.
Persons randomised to the control group will be accompanied by their health professional according to standard practice.
Participants randomised to the intervention group will receive the same smoking cessation advice, drug (varenicline, champix,..) prescription and support as participants in the control group, but they will also have a choice of being given free Nicotine Replacement Therapy (NRT) (transdermal patch, gum, spray, inhaler, sublingual tablets/lozenges) and/or an electronic cigarette + e-liquid on the spot to aid their quit attempt.
Follow-up appointments will take place at around 7 to 14 days, 1 month, 3 months and 6 months after inclusion, according to the participant and health professional availability.
The main outcome measure of this study will be the 7-day point prevalence tobacco abstinence at 6 months after inclusion (yes/no), defined as self-reported abstinence for at least 7 days, This self-reported abstinence will be validated by measured exhaled carbon monoxide, unless this measurement is unavailable due to the ongoing covid-19 pandemic.
A vizsgálat 2 csoportja
- The STOP interventionA vizsgált kezelés
The stop intervention is a heath professional (medical doctor) led intervention assisting smokers with low socioeconomic position in their smoking cessation attempt. It consists of routine care and adapted advice supplemented with a free delivery of any or several type(s) of nicotine replacement therapy (NRT) (patches, inhalers, gum, tablets, etc.) and/or an e-cigarette + e-liquid. The delivery of those smoking aids is based on the smokers' preference and choice.
- Standard CareMár használt kezelés, összehasonlításként
Participants randomised to the standard care group will be given standard care in assisting their smoking cessation attempt, but without free delivery of NRT or e-cigarettes. Standard care includes motivational interviewing, advice to quit and prescription for NRTs. The number and online address of the French smoking cessation support helpline could also be provided. Health professionals will also be in position to prescribe NRT or other treatments (for example: Varenicline or Bupropion) which can help with smoking cessation, according to routine practice. The health professional could also give advice on e-cigarette use if he or she finds it suitable.
Adatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- Sevrage Tabagique à l'Aide Des Outils dédiés Selon la Préférence, un Essai randomisé contrôlé Pragmatique
- A regiszteradat frissítve
- 2024. december 16.