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

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ClinicalTrials.gov Identifier: NCT03921606
Recruitment Status : Recruiting
First Posted : April 19, 2019
Last Update Posted : November 4, 2020
Sponsor:
Information provided by (Responsible Party):
The University of Hong Kong

Tracking Information
First Submitted Date  ICMJE March 4, 2019
First Posted Date  ICMJE April 19, 2019
Last Update Posted Date November 4, 2020
Actual Study Start Date  ICMJE April 10, 2019
Estimated Primary Completion Date March 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 16, 2019)
Biochemically validated smoking abstinence at 6 months [ Time Frame: 6-month follow-up ]
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2019)
  • biochemically validated smoking abstinence at 12 months [ Time Frame: 12-month follow-up ]
    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 [ Time Frame: 6- and 12-month follow-up ]
    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 [ Time Frame: 3-, 6- and 12-month follow-ups ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Using ICT to Deliver Brief Motivational Interviewing to Promote Smoking Cessation Among Smokers With Chronic Diseases
Official Title  ICMJE Using Information Communication Technology (Whatsapp/WeChat) to Deliver Brief Motivational Interviewing (i-BMI) to Promote Smoking Cessation Among Smokers With Chronic Diseases
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Smoking Cessation
Intervention  ICMJE
  • Behavioral: Motivational Interviewing (i-BMI)
    A brief MI via WhatsApp/WeChat
  • Behavioral: 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.
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Behavioral: Motivational Interviewing (i-BMI)
  • 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.
    Intervention: Behavioral: Individual face-to-face generic health advice
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 16, 2019)
720
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 1, 2021
Estimated Primary Completion Date March 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ho Cheung William Li, PhD +85239176634 william3@hku.hk
Contact: Long Kwan Ho, MPhil +85239176643 longkwan@hku.hk
Listed Location Countries  ICMJE Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03921606
Other Study ID Numbers  ICMJE NTWCREC19001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party The University of Hong Kong
Study Sponsor  ICMJE The University of Hong Kong
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ho Cheung William Li, PhD The University of Hong Kong
PRS Account The University of Hong Kong
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP