search
Back to results

Using ICT to Deliver Brief Motivational Interviewing to Promote Smoking Cessation Among Smokers With Chronic Diseases

Primary Purpose

Smoking Cessation

Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Motivational Interviewing (i-BMI)
Individual face-to-face generic health advice
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 - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Hong KongRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Experimental group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
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.
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.

Full Information

First Posted
March 4, 2019
Last Updated
November 2, 2020
Sponsor
The University of Hong Kong
search

1. Study Identification

Unique Protocol Identification Number
NCT03921606
Brief Title
Using ICT to Deliver Brief Motivational Interviewing to Promote Smoking Cessation Among Smokers With Chronic Diseases
Official Title
Using Information Communication Technology (Whatsapp/WeChat) to Deliver Brief Motivational Interviewing (i-BMI) to Promote Smoking Cessation Among Smokers With Chronic Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 10, 2019 (Actual)
Primary Completion Date
March 1, 2021 (Anticipated)
Study Completion Date
March 1, 2021 (Anticipated)

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 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.
Detailed 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.

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
720 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing (i-BMI)
Intervention Description
A brief MI via WhatsApp/WeChat
Intervention Type
Behavioral
Intervention Name(s)
Individual face-to-face generic health advice
Intervention Description
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.
Primary Outcome Measure Information:
Title
Biochemically validated smoking abstinence at 6 months
Description
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)
Time Frame
6-month follow-up
Secondary Outcome Measure Information:
Title
biochemically validated smoking abstinence at 12 months
Description
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)
Time Frame
12-month follow-up
Title
Self-reported 7-day point prevalence of smoking abstinence at 6 and 12 months
Description
Structured questionnaires will be developed by adopting or modifying international and/or locally validated instruments.
Time Frame
6- and 12-month follow-up
Title
Any behavioural change reported by the subjects at 3, 6 and 12 months
Description
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.
Time Frame
3-, 6- and 12-month follow-ups

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ho Cheung William Li, PhD
Phone
+85239176634
Email
william3@hku.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Long Kwan Ho, MPhil
Phone
+85239176643
Email
longkwan@hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ho Cheung William Li, PhD
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Hong Kong
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ho Cheung William Li, PhD
Phone
39176634
Email
william3@hku.hk
First Name & Middle Initial & Last Name & Degree
Ho Cheung William Li, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Using ICT to Deliver Brief Motivational Interviewing to Promote Smoking Cessation Among Smokers With Chronic Diseases

We'll reach out to this number within 24 hrs