Mixed and Match vs One-size-fits-all
tiistai 22. maaliskuuta 2022 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Tila
Ei vielä rekrytointia
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
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
Opintotyyppi
Interventio
Ilmoittautuminen (Odotettu)
500
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskeluyhteys
- Nimi: Katherine Lam, PhD
- Puhelinnumero: 27666420
- Sähköposti: kwkatlam@polyu.edu.hk
Tutki yhteystietojen varmuuskopiointi
- Nimi: Eva Ho, PhD
- Puhelinnumero: 27666417
- Sähköposti: kyeva.ho@polyu.edu.hk
Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
25 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Joo
Sukupuolet, jotka voivat opiskella
Kaikki
Kuvaus
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
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Muut: 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.
|
|
Muut: 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
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Self-reported abstinence at 6-month follow-up
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Screening rate
Aikaikkuna: 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
Aikaikkuna: at day 1
|
calculated by dividing the number of smokers who are eligible by the number who are screened.
|
at day 1
|
|
Randomization rate
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
|
Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Tutkijat
- Päätutkija: Katherine Lam, PhD, The Hong Kong Polytechnic University
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Odotettu)
Perjantai 1. heinäkuuta 2022
Ensisijainen valmistuminen (Odotettu)
Sunnuntai 31. joulukuuta 2023
Opintojen valmistuminen (Odotettu)
Sunnuntai 31. joulukuuta 2023
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Tiistai 18. toukokuuta 2021
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Tiistai 22. maaliskuuta 2022
Ensimmäinen Lähetetty (Todellinen)
Maanantai 28. maaliskuuta 2022
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Maanantai 28. maaliskuuta 2022
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Tiistai 22. maaliskuuta 2022
Viimeksi vahvistettu
Tiistai 1. maaliskuuta 2022
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muut tutkimustunnusnumerot
- SDTM-adult
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
EI
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Ei
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Ei
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .