Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05430789
Other study ID # SC discharge
Secondary ID HKU Clinical Tri
Status Recruiting
Phase N/A
First received
Last updated
Start date June 24, 2022
Est. completion date September 30, 2024

Study information

Verified date July 2022
Source The University of Hong Kong
Contact Man Ping Wang, PhD
Phone +852 3917 6636
Email mpwang@hku.hk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to enhance the general 5As brief advice model with interactive mobile phone-based intervention and active referral to community smoking cessation services for smoking patients discharged from hospitals.


Description:

Most smoking patients continue to smoke (76.1%) after being discharged from hospitals. Post-discharge smoking cessation (SC) support is one of the most cost-effective treatments. Hospitalisation offers a teachable moment to motivate patients to engage in post-discharge intervention, particularly those suffering from smoking-related diseases. Behavioral and psychosocial support increases abstinence in patients. Current clinical guidelines in the US (USPSTF) and UK (NICE) recommend health care professionals to provide brief SC support to patients using a brief advice model such as the 5As (Ask, Assess, Advice, Assist, Arrange) and further motivational 5Rs interventions (Relevance, Risks, Rewards, Roadblocks, and Repetition) if needed for those not having quit attempts. A key trial found that providing discharged patients with such proactive and sustained care as free SC medication, telephone calls to promote quitting, and additional counselling through clinic referrals increased 6-months validated quitting. Trained patient navigators providing patients in hospital primary clinics with tailored individual advice with medication and counselling referrals were found to be effective at improving 12-months quitting. Previous trials also showed connecting community smokers or smokers who visited emergency departments to existing SC services increased validated quitting at 6-months. Recent advances in mobile phone technology allow incorporating such innovations to improve the cost-effectiveness of post-discharge smoking cessation services. Mobile phones are increasingly used for monitoring and delivering personalised health treatments (mHealth). Regular text messaging was found to increased 6-months validated abstinence in general smokers, although the study was limited to pre-defined messages and interactions. A previous study reported an automated interactive voice response to be favored by patients and to increase abstinence. A text-based programme was tested in a Chinese population, and previous study found the delivery of interactive chat-based SC support via IM apps to be effective in increasing quitting. Chat-based SC interventions can provide real-time, personalised behavioral support and referrals to SC services. Mobile health is also part of the World Health Organization's strategies to combat smoking. Leveraging the success of previous trials in inpatients and a chat-based trial using IM to deliver behavioral support to community smokers, This study proposes to refine the 5As cessation model by incorporating a mobile phone-based intervention for patients recently discharged from hospitals. Recent trials showed a mobile phone-delivered cessation intervention combined with SC medication service increased abstinence. Recent trials showed a mobile phone-delivered cessation intervention combined with SC medication service increased abstinence. Active referral of community smokers to smoking cessation services increases service use and quitting but smoking patients were not referred for sustained cessation service in hospitals in Hong Kong. The effect of mobile phone-based intervention with active referral to link discharged patients for standard smoking cessation service remains unclear. Therefore, This study proposes to enhance the general 5As brief advice model with interactive mobile phone-based intervention and active referral to community smoking cessation services for smoking patients discharged from hospitals in Hong Kong.


Recruitment information / eligibility

Status Recruiting
Enrollment 770
Est. completion date September 30, 2024
Est. primary completion date May 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Smokers who are hospitalised or waiting for discharge in Hong Kong 2. Smoke cigarettes or alternative tobacco products (e.g. electronic cigarettes or heated tobacco products) daily at 1 month prior to hospitalisation 3. Have a smartphone with an IM app (WhatsApp or WeChat) and experience in using the app 4. Hong Kong adult residents (18+) able to communicate in Chinese (Cantonese or Mandarin) Exclusion Criteria: 1. Smokers not mentally fit for communication (e.g. psychiatry patients) 2. Smokers currently using SC medication or other SC services 3. Smokers hospitalised for more than 1 month 4. Perceived difficulty to use IM after discharge

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
5As brief advice
Participants will receive brief face-to-face advice following a 5As model at baseline: Ask: Smoking patients will be asked about their smoking status. Advise: Smoking patients will be advised to quit in a clear and personalised manner, with a focus on smoking-related diseases. Assess: Smoking patients will be assessed for their readiness to quit by assessing their self-efficacy and perceived importance. Assist: Those who are ready to quit will be assisted in setting a quit plan. Arrange: Refer to smoking cessation services.
Self-help e-booklet
A 12-page generic self-help smoking cessation e-booklet via IM apps, including: Highlights of the absolute risk of death due to smoking; Smoking and diseases management; Ten horrible pictorial warnings of health consequences of smoking and second-hand smoking; Benefits of quitting; Methods to quit and handle. withdrawal symptoms.
Nurse-led mHealth intervention
Participants will receive real-time mHealth behaviour and psychosocial support for 12 weeks after baseline through IM apps. mHealth intervention consists of two main parts: regular instant messaging on smoking cessation and personalized real-time mHealth chatting on smoking and disease (including active referral to smoking cessation service)
Regular intervention
Participants will receive text messages using IM app with content on general health and reminding the importance of participating in the follow-up surveys and biochemical validation for quitting.

Locations

Country Name City State
China School of Nursing, The University of Hong Kong Hong Kong Hong Kong

Sponsors (5)

Lead Sponsor Collaborator
The University of Hong Kong Kwong Wah Hospital, Princess Margaret Hospital, Hong Kong, Queen Elizabeth Hospital, Hong Kong, Queen Mary Hospital, Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Biochemically-validated abstinence Defined by exhaled carbon monoxide < 4 parts per million (ppm) and salivary cotinine < 30 ng/ml 6-month after baseline
Primary Biochemically-validated abstinence Defined by exhaled carbon monoxide < 4 parts per million (ppm) and salivary cotinine < 30 ng/ml 12-month after baseline
Secondary Self-reported past 7-day abstinence Being completely smoke-free in the past 7 days 6-month after baseline
Secondary Self-reported past 7-day abstinence Being completely smoke-free in the past 7 days 12-month after baseline
Secondary 24-weeks continuous abstinence Being completely smoke-free in the past 24 weeks 6-month after baseline
Secondary 24-weeks continuous abstinence Being completely smoke-free in the past 24 weeks 12-month after baseline
Secondary Intention to quit A single item will measure if smokers plan to quit smoking in 30 days, with response of yes or no 6-month after baseline
Secondary Intention to quit A single item will measure if smokers plan to quit smoking in 30 days, with response of yes or no 12-month after baseline
Secondary Number of quit attempt Defined by abstinence for at least 24 hours 6-month after baseline
Secondary Number of quit attempt Defined by abstinence for at least 24 hours 12-month after baseline
Secondary Smoking reduction Defined by at least 50% self-reported reduction in baseline daily number of cigarettes 6-month after baseline
Secondary Smoking reduction Defined by at least 50% self-reported reduction in baseline daily number of cigarettes 12-month after baseline
Secondary Nicotine dependence level Assessed by Heaviness of Smoking Index (range 0 to 6 with higher score indicating greater nicotine dependence) 6-month after baseline
Secondary Nicotine dependence level Assessed by Heaviness of Smoking Index (range 0 to 6 with higher score indicating greater nicotine dependence) 12-month after baseline
Secondary Smoking cessation service use Any access to a smoking cessation service 6-month after baseline
Secondary Smoking cessation service use Any access to a smoking cessation service 12-month after baseline
See also
  Status Clinical Trial Phase
Completed NCT03999411 - Smartphone Intervention for Smoking Cessation and Improving Adherence to Treatment Among HIV Patients Phase 4
Completed NCT04043728 - Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study N/A
Completed NCT04617444 - The ESTxENDS Trial- Substudy on Effects of Using Electronic Nicotine Delivery Systems (ENDS) on Olfactory Function N/A
Completed NCT02796391 - Facilitating Smoking Cessation With Reduced Nicotine Cigarettes Phase 2
Completed NCT03397511 - Incorporating Financial Incentives to Increase Smoking Cessation Among Asian Americans Residing in New York City N/A
Not yet recruiting NCT05188287 - A Culturally Tailored Smartphone Application for African American Smokers N/A
Recruiting NCT05264428 - The Effect of Honey on Lessening the Withdrawal Symptoms N/A
Recruiting NCT05846841 - Personalized Tobacco Treatment in Primary Care (MOTIVATE) N/A
Completed NCT04133064 - Assessment of the Pivot Breath Sensor: Single-Arm Cohort Study N/A
Completed NCT03187730 - Integrating Financial Management Counseling and Smoking Cessation Counseling to Reduce Health and Economic Disparities in Low-Income Immigrants Phase 4
Completed NCT03474783 - To Explore the Factors Affecting the Effectiveness of Smoking Cessation N/A
Completed NCT04635358 - Feasibility Study of Smoking Cessation for the Staff of a Hospital Center N/A
Terminated NCT03670264 - BE Smokefree: Behavioral Economics Incentives to Engage Adolescents in Smoking Cessation N/A
Not yet recruiting NCT06307496 - VIDeOS for Smoking Cessation N/A
Completed NCT02905656 - Strategies to Promote Cessation in Smokers Who Are Not Ready To Quit N/A
Completed NCT03206619 - A Health Recommeder System to Tailor Message Preferences in a Smoking Cessation Programme
Completed NCT02997657 - Positive Psychotherapy for Smoking Cessation Enhanced With Text Messaging: A Randomized Controlled Trial N/A
Completed NCT02562521 - A Smoking Cessation Intervention for Yale Dining Employees Phase 4
Completed NCT02239770 - Pharmacokinetics of Nicotine Film in Smokers N/A
Recruiting NCT02422914 - Benefits of Tobacco Free Cigarette N/A