Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

Mixed and Match vs One-size-fits-all

22. März 2022 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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

Studientyp

Interventionell

Einschreibung (Voraussichtlich)

500

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

25 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Sonstiges: Mixed and Match
Participants can choose to receive their own smoking cessation treatment options from our menu.
Verhalten: 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.
Sonstiges: Control
Participants will receive a self-help quitting leaflet
Sonstiges: Control
Participants in the control group will receive a self-help quitting leaflet issued by the TACO

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Self-reported abstinence at 6-month follow-up
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Screening rate
Zeitfenster: 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
Zeitfenster: at day 1
calculated by dividing the number of smokers who are eligible by the number who are screened.
at day 1
Randomization rate
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

The Hong Kong Polytechnic University

Ermittler

  • Hauptermittler: Katherine Lam, PhD, The Hong Kong Polytechnic University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Voraussichtlich)

1. Juli 2022

Primärer Abschluss (Voraussichtlich)

31. Dezember 2023

Studienabschluss (Voraussichtlich)

31. Dezember 2023

Studienanmeldedaten

Zuerst eingereicht

18. Mai 2021

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

22. März 2022

Zuerst gepostet (Tatsächlich)

28. März 2022

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

28. März 2022

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

22. März 2022

Zuletzt verifiziert

1. März 2022

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • SDTM-adult

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Klinische Studien zur Mixed and match Intervention

Suchen Sie nach ähnlichen Studien

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

CROs by country

CROs in Malta

Bedingungen

Seltene Krankheiten

Drogeninterventionen

Nahrungsergänzungsmittel

Sponsor / Mitarbeiter

Standorte

Abonnieren