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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04890223
Other study ID # NTWCREC19001_R1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2021
Est. completion date February 17, 2023

Study information

Verified date August 2023
Source The University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to examine the efficacy of brief MI delivered by mobile instant messaging tools in promoting smoking cessation among unmotivated smokers with chronic diseases. Participants in the intervention group will receive a brief MI intervention while the control group will receive a placebo intervention.


Description:

Smoking plays a causal role in the development of chronic diseases and may increase the risk of disease progression or recurrence, elevate the risk of mortality, and reduce the efficacy of treatment for disease sufferers. However, a majority of smokers with chronic diseases are unmotivated, having no intention to quit. These characteristics underscore the critical need for appropriate and effective smoking cessation interventions targeting this population. Nevertheless, most existing smoking cessation services are generic, and none seems to target smokers suffering from chronic diseases. A systematic review indicated that no study had yet examined the efficacy of a smoking cessation intervention designed specifically for unmotivated smokers with chronic diseases. Though MI was effective in promoting smoking cessation among the general population, was not effective for smokers with chronic diseases, who as has been seen tend to be unmotivated smokers. Brief MI, accordingly, is better suited to reaching these smokers in clinical settings, but the application of this approach to smoking cessation contexts has not been well studied. The proposed intervention will be designed to promote smoking cessation among unmotivated smokers with chronic diseases. To reduce the influence of the participants' baseline characteristics on the efficacy of the intervention, this study will be designed to motivate them to change a selected unfavourable behaviour as a means to reduce their resistance to the intervention. The foot-in-the-door technique served both to facilitate the recruitment for the study and to enhance the participants' compliance with the intervention, in the latter case by promoting change in their selected unfavourable behaviour as a preliminary to further change. The rationale is that a small successful step increases readiness to take a further, larger step, in this case, smoking cessation. Given that the exponential growth in the number of users of mobile instant messaging tools, they represent a resource for efforts to promote health and enhance treatment compliance. These were among the considerations that informed the development in this study of an intervention using brief MI delivered by mobile instant messaging tools to facilitate smoking cessation among unmotivated smokers with chronic diseases.


Recruitment information / eligibility

Status Completed
Enrollment 728
Est. completion date February 17, 2023
Est. primary completion date February 17, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Hong Kong Chinese over the age of 17 - Had smoked at least one cigarette per day over the previous three months - Had been diagnosed with at least one chronic disease - Able to speak Cantonese and read Chinese - Willing to take action to improve their health but had no intention to quit smoking - Had a smartphone and were able to use mobile instant messaging tools - Willing to receive health promotion advice and communicate through mobile instant messaging Exclusion Criteria: - Participating in other smoking cessation programs or services - With mental or cognitive impairment or communication problems

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Brief MI intervention
Brief MI intervention
Placebo intervention
Generic health advice consultations and self-help smoking cessation booklets

Locations

Country Name City State
Hong Kong 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 12 months The participants who self-reported not smoking within the past seven days will be invited to submit to a biochemical verification test of smoking abstinence, including an exhaled CO test and a salivary cotinine test. Smoking abstinence is defined as an exhaled CO level of less than 4 ppm and a saliva cotinine level lower than 15 ng/ml. 12-month follow-up
Secondary Biochemically validated smoking abstinence at 6 months The participants who self-reported not smoking within the past seven days will be invited to submit to a biochemical verification test of smoking abstinence, including an exhaled CO test and a salivary cotinine test. Smoking abstinence is defined as an exhaled CO level of less than 4 ppm and a saliva cotinine level lower than 15 ng/ml. 6-month follow-up
Secondary Self-reported smoking abstinence Self-reported not smoking within the past seven days 3-, 6-, or 12-month follow-ups
Secondary Intention to quit Individual's readiness to quit smoking within six months 3-, 6-, or 12-month follow-ups
Secondary Self-reported smoking reduction of at least 50% Reduction in cigarette consumption from the baseline by at least 50% 3-, 6-, or 12-month follow-ups
Secondary Quit attempts A period of intentional abstinence of more than 24 hours 3-, 6-, or 12-month follow-ups
Secondary Self-reported behavioural change Individual's perceived modification of the selected unfavourable behaviour 3-, 6-, or 12-month follow-ups
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