- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03921606
Using ICT to Deliver Brief Motivational Interviewing to Promote Smoking Cessation Among Smokers With Chronic Diseases
Using Information Communication Technology (Whatsapp/WeChat) to Deliver Brief Motivational Interviewing (i-BMI) to Promote Smoking Cessation Among Smokers With Chronic Diseases
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
Smoking exerts harmful effects on nearly every organ of the body and causes 7 million deaths worldwide each year. In Hong Kong, despite a decrease in the prevalence of daily cigarette smoking from 23.3% in 1982 to 10.0% in 2017, there are still 615,000 daily smokers. The evidence has shown that continued smoking in patients with chronic diseases can reduce the efficacy of medical treatments and increase the risk of treatment-related side effects. Nevertheless, many smokers with chronic diseases have a long smoking history, a strong nicotine dependency, and have not attempted or have no intention to quit. It is essential to develop and evaluate a more innovative and effective intervention to enhance the acceptability of smoking cessation for smokers with chronic diseases.
The proposed intervention will aim to facilitate the movement through five stages of change (pre-contemplation, contemplation, preparation, action and maintenance)15 via the (i) foot-in-the-door technique and (ii) a brief MI. The World Health Organization defines medical and public health practice supported by mobile devices as mobile health, a new strategy to promote health.21 Instant messaging, such as WhatsApp/WeChat delivered by mobile devices, is widely used for health promotion and treatment compliance.22 One advantage of using WhatsApp/WeChat is that it can offer quick, real-time interactions and continuing professional advice and support for subjects to manage their health-related lifestyle practices. Most importantly, WhatsApp/WeChat is more flexible, efficient and time-saving compared to face-to-face meetings to deliver a brief MI as face-to-face meetings would require the subjects to return several times for interventions. A systematic review of the use of mobile phone-based interventions for smoking cessation showed that smokers who received instant messages via mobile phones were more likely to abstain from smoking compared to those who used traditional face-to-face cessation services.23 A recent study conducted by our team in Hong Kong also showed that the use of WhatsApp for instant messaging was more effective in smoking relapse prevention for recent quitters.24 However, we found no reports or proposals based on the above conceptual framework and strategies in which ICTs were used with smokers who had no intention to quit.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Hong Kong, Hong Kong
- Reclutamento
- The University of Hong Kong
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- aged 18 years or above,
- able to speak Cantonese and read Chinese
- do not intend to quit smoking (pre-contemplation stage), but are willing to promote their health
- use a smartphone and can use an instant messaging tool (e.g., WhatsApp/WeChat)
- willing to receive health promotion advice and interact with our interventionist via WhatsApp/WeChat on a smartphone throughout the study period
Exclusion Criteria:
- inability to give informed consent or participate in our intervention due to impaired mental status, cognitive impairment or communication barriers
- participate in another smoking cessation programme or service
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Experimental group
The experimental group will receive a brief MI via WhatsApp/WeChat on a smartphone during the study period.
The brief MI messages will be delivered more intensively as preferred by the subject (usually not less than once every 2 to 3 days and no more than 2 times per day) for the first 6 months.
The frequency of delivering the messages via WhatsApp/WeChat will be interactive, depending on the subjects' actions and responses, and may take several sessions of chats within several days or weeks.
However, the total time spent by the interventionist will not be more than that for a traditional MI with several long sessions.
After 6 months, minimal messages will be provided to the subjects by merely following their progress of behavioural changes and responding to their questions to maintain contact until the 1-year follow-up.
The total time spent will be recorded and analysed.
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A brief MI via WhatsApp/WeChat
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Altro: Control group
The control group will receive individual face-to-face generic health advice (about 5 minutes) on a health-related lifestyle practice such as eating more vegetables and fruits, eating less high salt, fat or sugar foods, consuming less sugary drinks, engaging in more exercise of any kind or intensity, reducing alcohol consumption or reducing weight (if overweight or obese) in SOPCs.
A self-help booklet on smoking cessation published by the Hong Kong Council on Smoking and Health with Hotline will be also provided in the SOPCs.
The subjects in this group will receive the same schedule of follow-ups as in the intervention group, but they will not receive any follow-up booster intervention.
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Individual face-to-face generic health advice (about 5 minutes) on a health-related lifestyle practice such as eating more vegetables and fruits, eating less high salt, fat or sugar foods, consuming less sugary drinks, engaging in more exercise of any kind or intensity, reducing alcohol consumption or reducing weight (if overweight or obese).
A self-help booklet on smoking cessation published by the Hong Kong Council on Smoking and Health with Hotline will be also provided in the SOPCs.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Astinenza dal fumo validata biochimicamente a 6 mesi
Lasso di tempo: Controllo a 6 mesi
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L'astinenza dal fumo convalidata biochimicamente sarà confermata da un livello di cotinina nella saliva inferiore a 115 ng/ml nel test parallelo e un livello di monossido di carbonio nell'aria espirata inferiore a 9 parti per milione (ppm)
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Controllo a 6 mesi
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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astinenza dal fumo validata biochimicamente a 12 mesi
Lasso di tempo: Controllo a 12 mesi
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L'astinenza dal fumo convalidata biochimicamente sarà confermata da un livello di cotinina nella saliva inferiore a 115 ng/ml nel test parallelo e un livello di monossido di carbonio nell'aria espirata inferiore a 9 parti per milione (ppm)
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Controllo a 12 mesi
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Self-reported 7-day point prevalence of smoking abstinence at 6 and 12 months
Lasso di tempo: 6- and 12-month follow-up
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Structured questionnaires will be developed by adopting or modifying international and/or locally validated instruments.
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6- and 12-month follow-up
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Any behavioural change reported by the subjects at 3, 6 and 12 months
Lasso di tempo: 3-, 6- and 12-month follow-ups
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EQ-5D five-level questionnaire (EQ-5D-5L) will be administered at 3, 6, and 12 months.
Chinese-specific EQ-5D-5L value set will enable the estimation of EQ-5D-5L health utility scores applicable for Chinese population.
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3-, 6- and 12-month follow-ups
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Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- NTWCREC19001
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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 .
Prove cliniche su Smettere di fumare
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Poitiers University HospitalNon ancora reclutamentoTerapia sostitutiva della nicotina | Professionisti sanitari | Desiderio di Tabacco | Tabacco CessationFrancia
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Nij Smellinghe HosptialCompletato
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Ajay Israni, MDCompletato
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