Mixed and Match vs One-size-fits-all
22 marca 2022 zaktualizowane przez: 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.
Przegląd badań
Status
Jeszcze nie rekrutacja
Warunki
Interwencja / Leczenie
Szczegółowy opis
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 studiów
Interwencyjne
Zapisy (Oczekiwany)
500
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Katherine Lam, PhD
- Numer telefonu: 27666420
- E-mail: kwkatlam@polyu.edu.hk
Kopia zapasowa kontaktu do badania
- Nazwa: Eva Ho, PhD
- Numer telefonu: 27666417
- E-mail: kyeva.ho@polyu.edu.hk
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
25 lat i starsze (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Tak
Płeć kwalifikująca się do nauki
Wszystko
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Inny: Mixed and Match
Participants can choose to receive their own smoking cessation treatment options from our menu.
|
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.
|
|
Inny: Control
Participants will receive a self-help quitting leaflet
|
Participants in the control group will receive a self-help quitting leaflet issued by the TACO
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Self-reported abstinence at 6-month follow-up
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Screening rate
Ramy czasowe: 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
Ramy czasowe: at day 1
|
calculated by dividing the number of smokers who are eligible by the number who are screened.
|
at day 1
|
|
Randomization rate
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Śledczy
- Główny śledczy: Katherine Lam, PhD, The Hong Kong Polytechnic University
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Oczekiwany)
1 lipca 2022
Zakończenie podstawowe (Oczekiwany)
31 grudnia 2023
Ukończenie studiów (Oczekiwany)
31 grudnia 2023
Daty rejestracji na studia
Pierwszy przesłany
18 maja 2021
Pierwszy przesłany, który spełnia kryteria kontroli jakości
22 marca 2022
Pierwszy wysłany (Rzeczywisty)
28 marca 2022
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
28 marca 2022
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
22 marca 2022
Ostatnia weryfikacja
1 marca 2022
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- SDTM-adult
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .