Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Effectiveness of Negotiating Self-determination to Reduce Cigarette Consumption

2 novembre 2020 aggiornato da: The University of Hong Kong

The Effectiveness of Negotiating Self-Determination to Reduce Cigarette Consumption (NSD-RCC) Among Smokers Attending Outpatient Clinics: A Cluster Randomized Controlled Trial

Background: Smokers attended to outpatient clinics present an excellent 'teachable moment' for smoking cessation interventions. This protocol paper describes the rationale and methods of a large randomized controlled trial which aims to evaluate the effectiveness of negotiating self-determination to reduce cigarette consumption among smokers attending outpatient clinics

Methods: A randomized controlled trial will be conducted in 10 out-patient clinics in Hong Kong. Subjects in the intervention group will receive a brief intervention on smoking reduction plus a smoking reduction leaflet. Additionally, subjects will be asked to think about a smoking reduction schedule for themselves after the negotiation with the counsellor. Subjects in the control group will receive a brief advice on quitting plus a leaflet on smoking cessation. Four consecutive (1, 3, 6 and 12 months) follow-ups will be conducted. The primary outcome measure is biochemically validated abstinence at 6 months. Secondary outcomes are: (i) biochemically validated abstinence at 12 months, (ii) self-reported 7-day point prevalence of abstinence at 6 and 12 months, (iii) self-reported reduction of ≥ 50% in cigarette consumption at 6 and 12 months, and (iv) self-efficacy against tobacco at 6 and 12 months.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Descrizione dettagliata

This study aims to test the effectiveness of negotiating self-determination to reduce cigarette consumption (NSD-RCC) among smokers attending outpatient clinics.

Intervention Group (QP) Subjects in this group will receive a brief intervention on smoking reduction with a warning message plus a smoking reduction leaflet (the content will include a roadmap of smoking reduction strategy and information on how to cope with nicotine withdrawal symptoms). The whole intervention will last about 1 minute or slightly longer if necessary. In addition, subjects will be asked to think about a tailored smoking reduction schedule for themselves after the negotiation with the trained counsellor. For the subsequent telephone follow up in the intervention group, information on reduction and cessation will be collected, followed by a "booster" intervention, which will repeat the health warning to positively encourage them to reinforce their efforts and the next reduction target.

Control Group (QI) Subjects in the QI group will always be advised to quit immediately rather than to quit progressively. Subjects will receive a brief advice on quitting with a warning message similar to subjects in the QP group. In addition, subjects will receive a self-help quitting pamphlet published by the Hong Kong Council on Smoking and Health (COSH). Unlike the QP group, subjects in the QI group will not receive smoking reduction intervention and leaflet, and "booster" intervention during telephone follow-ups. However, they will undergo a similar schedule of telephone follow-up as those in the QP group.

Data collection

After completing the baseline questionnaire, subjects will receive proposed intervention according to their group assignment. Four consecutive follow-ups (at 1, 3, 6 and 12 months) will be conducted over the telephone by trained interviewers. Interviewers will first carry out outcome assessments with blinding to group status. Then, the group status will be disclosed so that the intervention group will receive the booster intervention and the control group will not. Smokers who have successfully quit smoking at 6-month will be invited to come back to the out-patient clinic and have biochemical validation tests (saliva cotinine test and exhaled CO test).

Analysis Data analysis will be performed using the Statistical Package for Social Science. We will compare the baseline characteristics of the participants by chi-square test for categorical variables and F-test for continuous variables between the intervention and the control group. We shall use the chi-square test to assess the effect of intervention and calculate the crude odds ratio (OR) with 95% confidence interval (CI) for the primary and secondary outcomes. Those who are lost to follow-up or refuse to participate in the validation tests, will be treated as smokers with no reduction in cigarette consumption compared with (a) baseline, as the main analysis (by intention to treat), (b) the most recent level and (c) complete case (per protocol) analysis by excluding subjects with missing data as a sensitivity analysis.

Tipo di studio

Interventistico

Iscrizione (Anticipato)

1566

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: William, Ho Cheung LI, PhD
  • Numero di telefono: 39176634
  • Email: william3@hku.hk

Backup dei contatti dello studio

  • Nome: Ka Yan, HO Ho, MPhil
  • Numero di telefono: 39176328
  • Email: devilbb@hku.hk

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

smokers

  • who are Chinese
  • aged 18 years or above
  • who smoke at least two cigarettes per day
  • with moderate to severe nicotine dependence, and
  • have no intention to quit smoking ≤7 days, but are interested in reducing the number of cigarettes smoked per day .

Exclusion Criteria:

smokers

  • with unstable medical conditions as advised by the doctor in charge,
  • with poor cognitive state or mental illness,
  • who participate in other smoking cessation programmes or services,
  • with mild nicotine dependence, or
  • who claim that they can quit ≤7 days

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Smoking reduction
Subjects will receive a brief intervention on smoking reduction with a warning message plus a smoking reduction leaflet. They will be asked to think about a tailored smoking reduction schedule for themselves after the negotiation with the trained counsellor. The trained counsellor will negotiate a schedule with subjects to reduce their smoking over an acceptable level. For the subsequent telephone follow up in the intervention group, information on reduction and cessation will be collected, followed by a "booster" intervention, which will repeat the health warning to positively encourage them to reinforce their efforts and the next reduction target. Four consecutive (1, 3, 6 and 12 months) follow-ups will be conducted over the telephone by trained interviewers.
A brief intervention on smoking reduction plus a smoking reduction leaflet
Comparatore placebo: Smoking Cessation
Subjects in the QI group will always be advised to quit immediately rather than to quit progressively. Subjects will receive a brief advice on quitting with a warning message similar to subjects in the QP group. In addition, subjects will receive a self-help quitting pamphlet published by the Hong Kong Council on Smoking and Health (COSH). Unlike the QP group, subjects in the QI group will not receive smoking reduction intervention and leaflet, and "booster" intervention during telephone follow-ups. However, they will undergo a similar schedule of telephone follow-up as those in the QP group.
A brief advice on quitting plus a leaflet on smoking cessation

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
biochemically validated abstinence using exhaled CO test
Lasso di tempo: 6 months
6 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
astinenza convalidata biochimicamente utilizzando il test della CO espirata
Lasso di tempo: 12 mesi
12 mesi
prevalenza puntiforme autodichiarata di 7 giorni di astinenza
Lasso di tempo: 6 mesi
6 mesi
prevalenza puntiforme autodichiarata di 7 giorni di astinenza
Lasso di tempo: 12 mesi
12 mesi
riduzione autodichiarata di ≥ 50% nel consumo di sigarette
Lasso di tempo: 6 mesi
6 mesi
riduzione autodichiarata di ≥ 50% nel consumo di sigarette
Lasso di tempo: 12 mesi
12 mesi
self-efficacy against tobacco
Lasso di tempo: 6 months
Subjects' self-efficacy against tobacco was assessed by using 12-item Smoking Self-efficacy Questionnaire (SEQ-12). SEQ-12 is a valid and reliable scale, which has been used in both research and clinical setting.
6 months
self-efficacy against tobacco
Lasso di tempo: 12 months
Subjects' self-efficacy against tobacco was assessed by using 12-item Smoking Self-efficacy Questionnaire (SEQ-12). SEQ-12 is a valid and reliable scale, which has been used in both research and clinical setting.
12 months
biochemically validated abstinence using saliva cotinine test
Lasso di tempo: 6 months
6 months
biochemically validated abstinence using saliva cotinine test
Lasso di tempo: 12 months
12 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: William, Ho Cheung LI, PhD, The University of Hong Kong

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Anticipato)

1 giugno 2021

Completamento primario (Anticipato)

1 dicembre 2022

Completamento dello studio (Anticipato)

1 dicembre 2023

Date di iscrizione allo studio

Primo inviato

26 aprile 2016

Primo inviato che soddisfa i criteri di controllo qualità

3 maggio 2016

Primo Inserito (Stima)

5 maggio 2016

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 novembre 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 novembre 2020

Ultimo verificato

1 ottobre 2020

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • GRF

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

No

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Sottoscrivi