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Mixed and Match vs One-size-fits-all

22. března 2022 aktualizováno: Dr Katherine Lam, The Hong Kong Polytechnic University

Mixed and Match Versus One-size-fits-all: A Randomized Controlled Trial of Self-determination Theory on a Menu of Smoking Cessation Options (SDTM) Among Adult Smokers

Most existing smoking cessation services are based on '5A's' and '5R's' models which are recognized by the World Health Organization as a standardized tool for smoking cessation. While there are more techniques that are known to be effective and could be incorporated in existing smoking cessation interventions to further promote their effectiveness. This study is to examine the effectiveness SDTM in assisting adult smokers in Hong Kong to quit.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

A randomized controlled trial (RCT) will be conducted. One-hundred adult smokers aged 25 or above will be recruited from smoking hotspots in Hong Kong. Participants in the intervention group will be contacted by our trained research assistant to receive a telephone counselling session at baseline. Participants can choose to receive their own smoking cessation treatment options from our menu. Control group participants will only receive a self-help quitting leaflet

Typ studie

Intervenční

Zápis (Očekávaný)

500

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

25 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  • have smoking in the previous 30 days.
  • be above 25 years old
  • able to speak Cantonese and read Chinese

Exclusion Criteria:

  • who are receiving current smoking cessation services
  • report psychological disorders
  • at risk of suicide

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Jiný: Mixed and Match
Participants can choose to receive their own smoking cessation treatment options from our menu.
Behaviorální: Mixed and match Intervention
Participants will receive a brief 15-minute counselling session based on the 5A's' and '5R's' models by our trained research assistant. Participants will be able to choose their smoking cessation treatment options from our menu.
Jiný: Control
Participants will receive a self-help quitting leaflet
Jiný: Control
Participants in the control group will receive a self-help quitting leaflet issued by the TACO

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Self-reported abstinence at 6-month follow-up
Časové okno: At 6-month follow-up
participants will be asked about their self-reported abstinence in the past 7 and 30 days
At 6-month follow-up
Biochemically validated abstinence
Časové okno: At 6 months follow-up
validate the self-reported abstinence if the level of carbon monoxide in expired air was less than 4 parts per million and saliva cotinine level was less than100 ng/mL in parallel tests
At 6 months follow-up
Self-efficacy at 6-month follow-up
Časové okno: At 6-month follow-up
Participants will be asked about their self-efficacy in quitting. The score ranges from 0 to 10. Higher scores represent a higher self-efficacy.
At 6-month follow-up

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Screening rate
Časové okno: at day 1
calculated as the number of smokers screened at smoking hotspots by the RA divided by number of smokers available
at day 1
Eligibility rate
Časové okno: at day 1
calculated by dividing the number of smokers who are eligible by the number who are screened.
at day 1
Randomization rate
Časové okno: at day 1
calculated by dividing the number of smokers who are randomized into intervention and control groups by those who provide consent.
at day 1
Attendance rate
Časové okno: Immediately after the training workshop
calculated by dividing the number of smokers who complete the intervention by those who are randomized.
Immediately after the training workshop
Retention rate at 1-week follow-up
Časové okno: At 1-week follow-up
calculated by dividing the number of smokers who remain in the study by those who are randomized
At 1-week follow-up
Retention rate at 1-month follow-up
Časové okno: At 1-month follow-up
calculated by dividing the number of smokers who remain in the study by those who are randomized
At 1-month follow-up
Retention rate at 6-month follow-up
Časové okno: At 6-month follow-up
calculated by dividing the number of smokers who remain in the study by those who are randomized
At 6-month follow-up
Retention rate at 3-month follow-up
Časové okno: At 3-month follow-up
calculated by dividing the number of smokers who remain in the study by those who are randomized
At 3-month follow-up
Adherence to intervention protocol at 1-week follow-up
Časové okno: At 1-week follow-up
calculated by dividing the number of smokers who follow and practice the chosen treatment options by those who are randomized
At 1-week follow-up
Adherence to intervention protocol at 1-month follow-up
Časové okno: At 1-month follow-up
calculated by dividing the number of smokers who follow and practice the chosen treatment options by those who are randomized
At 1-month follow-up
Adherence to intervention protocol at 3-month follow-up
Časové okno: At 3-month follow-up
calculated by dividing the number of smokers who follow and practice the chosen treatment options by those who are randomized
At 3-month follow-up
Adherence to intervention protocol at 6-month follow-up
Časové okno: At 6-month follow-up
calculated by dividing the number of smokers who follow and practice the chosen treatment options by those who are randomized
At 6-month follow-up
Complete rate at 1-week follow-up
Časové okno: At 1-week follow-up
calculated by dividing the number of smokers who returned questionnaires by the number of questionnaires distributed
At 1-week follow-up
Complete rate at 1-month follow-up
Časové okno: At 1-month follow-up
calculated by dividing the number of smokers who returned questionnaires by the number of questionnaires distributed
At 1-month follow-up
Complete rate at 3-month follow-up
Časové okno: At 3-month follow-up
calculated by dividing the number of smokers who returned questionnaires by the number of questionnaires distributed
At 3-month follow-up
Complete rate at 6-month follow-up
Časové okno: At 6-month follow-up
calculated by dividing the number of smokers who returned questionnaires by the number of questionnaires distributed
At 6-month follow-up
Missing data at 1-week follow-up
Časové okno: At 1-week follow-up
calculated as the percentage of missing values in the dataset
At 1-week follow-up
Missing data at 1-month follow-up
Časové okno: At 1-month follow-up
calculated as the percentage of missing values in the dataset
At 1-month follow-up
Missing data at 3-month follow-up
Časové okno: At 3-month follow-up
calculated as the percentage of missing values in the dataset
At 3-month follow-up
Missing data at 6-month follow-up
Časové okno: At 6-month follow-up
calculated as the percentage of missing values in the dataset
At 6-month follow-up
Adverse events at 6-month follow-up
Časové okno: At 6-month follow-up
Participants will report any unfavorable and unintended events
At 6-month follow-up
Adverse events at 1-week follow-up
Časové okno: At 1-week follow-up
Participants will report any unfavorable and unintended events
At 1-week follow-up
Adverse events at 1-month follow-up
Časové okno: At 1-month follow-up
Participants will report any unfavorable and unintended events
At 1-month follow-up
Adverse events at 3-month follow-up
Časové okno: At 3-month follow-up
Participants will report any unfavorable and unintended events
At 3-month follow-up
Self-reported abstinence at 1-week follow-up
Časové okno: At 1-week follow-up
Participants will be asked about their self-reported abstinence in the past 7 and 30 days
At 1-week follow-up
Self-reported abstinence at 1-month follow-up
Časové okno: At 1-month follow-up
participants will be asked about their self-reported abstinence in the past 7 and 30 days
At 1-month follow-up
Self-reported abstinence at 3-month follow-up
Časové okno: At 3-month follow-up
participants will be asked about their self-reported abstinence in the past 7 and 30 days
At 3-month follow-up
Self-efficacy at 1-week follow-up
Časové okno: at 1-week follow-up
Participants will be asked about their self-efficacy in quitting. The score ranges from 0 to 10. Higher scores represent a higher self-efficacy.
at 1-week follow-up
Self-efficacy at 1-month follow-up
Časové okno: at 1-month follow-up
Participants will be asked about their self-efficacy in quitting. The score ranges from 0 to 10. Higher scores represent a higher self-efficacy.
at 1-month follow-up
Self-efficacy at 3-month follow-up
Časové okno: at 3-month follow-up
Participants will be asked about their self-efficacy in quitting. The score ranges from 0 to 10. Higher scores represent a higher self-efficacy.
at 3-month follow-up

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

The Hong Kong Polytechnic University

Vyšetřovatelé

  • Vrchní vyšetřovatel: Katherine Lam, PhD, The Hong Kong Polytechnic University

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Očekávaný)

1. července 2022

Primární dokončení (Očekávaný)

31. prosince 2023

Dokončení studie (Očekávaný)

31. prosince 2023

Termíny zápisu do studia

První předloženo

18. května 2021

První předloženo, které splnilo kritéria kontroly kvality

22. března 2022

První zveřejněno (Aktuální)

28. března 2022

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

28. března 2022

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

22. března 2022

Naposledy ověřeno

1. března 2022

Více informací

Termíny související s touto studií

Klíčová slova

Další identifikační čísla studie

  • SDTM-adult

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

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Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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