Mixed and Match vs One-size-fits-all
22. mars 2022 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Studietype
Intervensjonell
Registrering (Forventet)
500
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Katherine Lam, PhD
- Telefonnummer: 27666420
- E-post: kwkatlam@polyu.edu.hk
Studer Kontakt Backup
- Navn: Eva Ho, PhD
- Telefonnummer: 27666417
- E-post: kyeva.ho@polyu.edu.hk
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
25 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Annen: 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.
|
|
Annen: 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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Self-reported abstinence at 6-month follow-up
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Screening rate
Tidsramme: 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
Tidsramme: at day 1
|
calculated by dividing the number of smokers who are eligible by the number who are screened.
|
at day 1
|
|
Randomization rate
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Katherine Lam, PhD, The Hong Kong Polytechnic University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Forventet)
1. juli 2022
Primær fullføring (Forventet)
31. desember 2023
Studiet fullført (Forventet)
31. desember 2023
Datoer for studieregistrering
Først innsendt
18. mai 2021
Først innsendt som oppfylte QC-kriteriene
22. mars 2022
Først lagt ut (Faktiske)
28. mars 2022
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
28. mars 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
22. mars 2022
Sist bekreftet
1. mars 2022
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- SDTM-adult
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .