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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03921606
Other study ID # NTWCREC19001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 10, 2019
Est. completion date March 1, 2021

Study information

Verified date November 2020
Source The University of Hong Kong
Contact Ho Cheung William Li, PhD
Phone +85239176634
Email william3@hku.hk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to evaluate the effectiveness of a general health promotion (GHP) approach using information communication technology (ICT) to deliver a brief motivational interviewing (MI) to motivate smokers with chronic diseases to quit smoking. Subjects in the intervention group will receive a GHP approach using ICT (e.g., WhatsApp/WeChat) to deliver brief MI. Subjects in the control group will receive an individual face-to-face generic health advice plus a self-help booklet on smoking cessation at the time of recruitment.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 720
Est. completion date March 1, 2021
Est. primary completion date March 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Motivational Interviewing (i-BMI)
A brief MI via WhatsApp/WeChat
Individual face-to-face generic health advice
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.

Locations

Country Name City State
Hong Kong The University of Hong Kong Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary Biochemically validated smoking abstinence at 6 months The biochemically validated smoking abstinence will be confirmed by a saliva cotinine level of less than 115 ng/ml in parallel test and a carbon monoxide level in expired air of less than 9 parts per million (ppm) 6-month follow-up
Secondary biochemically validated smoking abstinence at 12 months The biochemically validated smoking abstinence will be confirmed by a saliva cotinine level of less than 115 ng/ml in parallel test and a carbon monoxide level in expired air of less than 9 parts per million (ppm) 12-month follow-up
Secondary Self-reported 7-day point prevalence of smoking abstinence at 6 and 12 months Structured questionnaires will be developed by adopting or modifying international and/or locally validated instruments. 6- and 12-month follow-up
Secondary Any behavioural change reported by the subjects at 3, 6 and 12 months 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. 3-, 6- and 12-month follow-ups
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