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Efficacy of Brief MI Delivered Via Mobile Instant Messaging to Help Unmotivated Smokers With Chronic Diseases to Quit

Primary Purpose

Smoking Cessation

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Brief MI intervention
Placebo intervention
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Smoking Cessation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Hong Kong

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention group

Control group

Arm Description

The participants in the intervention group will be asked to identify an unfavourable behaviour that they wish to change when filling out the baseline questionnaire. The research nurse will conduct the individual face-to-face brief MI interviews for this purpose, which will last for approximately five to ten minutes. After the face-to-face brief MI interviews, the participants in the intervention group will receive brief MI messages individually by means of mobile instant messaging for six months from the baseline. After six months, the brief MI messages will cease to be delivered to the participants in the intervention group, with whom the research team will then maintain only minimal contact until the 12-month follow-up.

Participants in the control group will be asked to identify an unfavourable behaviour that they want to change at the baseline but, rather than brief MI interviews delivered face-to-face, received generic health advice consultations on the selected unfavourable behaviour that lasted approximately five to ten minutes. Each participant will receive a self-help smoking cessation booklet titled Be Smart, Quit Smoking! published by the Hong Kong Council on Smoking and Health with information about the negative health consequences of smoking, reasons to quit, strategies for quitting, and smoking cessation services available in Hong Kong along with a public quitline number (specifically, 1833183). Those who express the intention to quit at follow-ups will receive usual smoking cessation support.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Self-reported smoking abstinence
Self-reported not smoking within the past seven days
Intention to quit
Individual's readiness to quit smoking within six months
Self-reported smoking reduction of at least 50%
Reduction in cigarette consumption from the baseline by at least 50%
Quit attempts
A period of intentional abstinence of more than 24 hours
Self-reported behavioural change
Individual's perceived modification of the selected unfavourable behaviour

Full Information

First Posted
May 12, 2021
Last Updated
August 2, 2023
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT04890223
Brief Title
Efficacy of Brief MI Delivered Via Mobile Instant Messaging to Help Unmotivated Smokers With Chronic Diseases to Quit
Official Title
Efficacy of Brief Motivational Interviewing Delivered Via Mobile Instant Messaging Tools to Promote Smoking Cessation Among Unmotivated Smokers With Chronic Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
February 17, 2023 (Actual)
Study Completion Date
February 17, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking Cessation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
728 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
The participants in the intervention group will be asked to identify an unfavourable behaviour that they wish to change when filling out the baseline questionnaire. The research nurse will conduct the individual face-to-face brief MI interviews for this purpose, which will last for approximately five to ten minutes. After the face-to-face brief MI interviews, the participants in the intervention group will receive brief MI messages individually by means of mobile instant messaging for six months from the baseline. After six months, the brief MI messages will cease to be delivered to the participants in the intervention group, with whom the research team will then maintain only minimal contact until the 12-month follow-up.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Participants in the control group will be asked to identify an unfavourable behaviour that they want to change at the baseline but, rather than brief MI interviews delivered face-to-face, received generic health advice consultations on the selected unfavourable behaviour that lasted approximately five to ten minutes. Each participant will receive a self-help smoking cessation booklet titled Be Smart, Quit Smoking! published by the Hong Kong Council on Smoking and Health with information about the negative health consequences of smoking, reasons to quit, strategies for quitting, and smoking cessation services available in Hong Kong along with a public quitline number (specifically, 1833183). Those who express the intention to quit at follow-ups will receive usual smoking cessation support.
Intervention Type
Behavioral
Intervention Name(s)
Brief MI intervention
Intervention Description
Brief MI intervention
Intervention Type
Behavioral
Intervention Name(s)
Placebo intervention
Intervention Description
Generic health advice consultations and self-help smoking cessation booklets
Primary Outcome Measure Information:
Title
Biochemically validated smoking abstinence at 12 months
Description
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.
Time Frame
12-month follow-up
Secondary Outcome Measure Information:
Title
Biochemically validated smoking abstinence at 6 months
Description
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.
Time Frame
6-month follow-up
Title
Self-reported smoking abstinence
Description
Self-reported not smoking within the past seven days
Time Frame
3-, 6-, or 12-month follow-ups
Title
Intention to quit
Description
Individual's readiness to quit smoking within six months
Time Frame
3-, 6-, or 12-month follow-ups
Title
Self-reported smoking reduction of at least 50%
Description
Reduction in cigarette consumption from the baseline by at least 50%
Time Frame
3-, 6-, or 12-month follow-ups
Title
Quit attempts
Description
A period of intentional abstinence of more than 24 hours
Time Frame
3-, 6-, or 12-month follow-ups
Title
Self-reported behavioural change
Description
Individual's perceived modification of the selected unfavourable behaviour
Time Frame
3-, 6-, or 12-month follow-ups

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ho Cheung William Li, PhD
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Hong Kong
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy of Brief MI Delivered Via Mobile Instant Messaging to Help Unmotivated Smokers With Chronic Diseases to Quit

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