- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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
Przegląd badań
Status
Warunki
Szczegółowy opis
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.
Typ studiów
Zapisy (Oczekiwany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Hong Kong, Hongkong
- Rekrutacyjny
- The University of Hong Kong
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: 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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Inny: 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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Potwierdzona biochemicznie abstynencja od palenia po 6 miesiącach
Ramy czasowe: 6-miesięczna obserwacja
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Potwierdzona biochemicznie abstynencja od palenia zostanie potwierdzona przez poziom kotyniny w ślinie poniżej 115 ng/ml w teście równoległym oraz poziom tlenku węgla w wydychanym powietrzu poniżej 9 części na milion (ppm)
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6-miesięczna obserwacja
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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biochemicznie potwierdzona abstynencja od palenia po 12 miesiącach
Ramy czasowe: 12-miesięczna obserwacja
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Potwierdzona biochemicznie abstynencja od palenia zostanie potwierdzona przez poziom kotyniny w ślinie poniżej 115 ng/ml w teście równoległym oraz poziom tlenku węgla w wydychanym powietrzu poniżej 9 części na milion (ppm)
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12-miesięczna obserwacja
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Self-reported 7-day point prevalence of smoking abstinence at 6 and 12 months
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Oczekiwany)
Ukończenie studiów (Oczekiwany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- NTWCREC19001
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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