Post-discharge Cessation for Smoking Patients

NCT ID: NCT05430789

Last Updated: 2022-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

770 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-24

Study Completion Date

2024-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Smoking Cessation Post-discharge Mobile Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention group

5As brief advice + Self-help ebooklet + Nurse-led mHealth intervention

Group Type EXPERIMENTAL

5As brief advice

Intervention Type BEHAVIORAL

Participants will receive brief face-to-face advice following a 5As model at baseline:

1. Ask: Smoking patients will be asked about their smoking status.
2. Advise: Smoking patients will be advised to quit in a clear and personalised manner, with a focus on smoking-related diseases.
3. Assess: Smoking patients will be assessed for their readiness to quit by assessing their self-efficacy and perceived importance.
4. Assist: Those who are ready to quit will be assisted in setting a quit plan.
5. Arrange: Refer to smoking cessation services.

Self-help e-booklet

Intervention Type BEHAVIORAL

A 12-page generic self-help smoking cessation e-booklet via IM apps, including:

1. Highlights of the absolute risk of death due to smoking;
2. Smoking and diseases management;
3. Ten horrible pictorial warnings of health consequences of smoking and second-hand smoking;
4. Benefits of quitting;
5. Methods to quit and handle. withdrawal symptoms.

Nurse-led mHealth intervention

Intervention Type BEHAVIORAL

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)

Control group

5As brief advice + Self-help ebooklet + Text messaging

Group Type ACTIVE_COMPARATOR

5As brief advice

Intervention Type BEHAVIORAL

Participants will receive brief face-to-face advice following a 5As model at baseline:

1. Ask: Smoking patients will be asked about their smoking status.
2. Advise: Smoking patients will be advised to quit in a clear and personalised manner, with a focus on smoking-related diseases.
3. Assess: Smoking patients will be assessed for their readiness to quit by assessing their self-efficacy and perceived importance.
4. Assist: Those who are ready to quit will be assisted in setting a quit plan.
5. Arrange: Refer to smoking cessation services.

Self-help e-booklet

Intervention Type BEHAVIORAL

A 12-page generic self-help smoking cessation e-booklet via IM apps, including:

1. Highlights of the absolute risk of death due to smoking;
2. Smoking and diseases management;
3. Ten horrible pictorial warnings of health consequences of smoking and second-hand smoking;
4. Benefits of quitting;
5. Methods to quit and handle. withdrawal symptoms.

Regular intervention

Intervention Type BEHAVIORAL

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.

Interventions

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5As brief advice

Participants will receive brief face-to-face advice following a 5As model at baseline:

1. Ask: Smoking patients will be asked about their smoking status.
2. Advise: Smoking patients will be advised to quit in a clear and personalised manner, with a focus on smoking-related diseases.
3. Assess: Smoking patients will be assessed for their readiness to quit by assessing their self-efficacy and perceived importance.
4. Assist: Those who are ready to quit will be assisted in setting a quit plan.
5. Arrange: Refer to smoking cessation services.

Intervention Type BEHAVIORAL

Self-help e-booklet

A 12-page generic self-help smoking cessation e-booklet via IM apps, including:

1. Highlights of the absolute risk of death due to smoking;
2. Smoking and diseases management;
3. Ten horrible pictorial warnings of health consequences of smoking and second-hand smoking;
4. Benefits of quitting;
5. Methods to quit and handle. withdrawal symptoms.

Intervention Type BEHAVIORAL

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)

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Queen Mary Hospital, Hong Kong

OTHER

Sponsor Role collaborator

Princess Margaret Hospital, Hong Kong

OTHER_GOV

Sponsor Role collaborator

Queen Elizabeth Hospital, Hong Kong

OTHER

Sponsor Role collaborator

Kwong Wah Hospital

OTHER

Sponsor Role collaborator

The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Dr. Wang Man-Ping

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Man Ping Wang, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

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School of Nursing, The University of Hong Kong

Hong Kong, Hong Kong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Man Ping Wang, PhD

Role: CONTACT

+852 3917 6636

Yingpei Zeng, MNurs

Role: CONTACT

+852 3917 6649

Facility Contacts

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Man Ping Wang, PhD

Role: primary

Yingpei Zeng, MNurs

Role: backup

Other Identifiers

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HKU Clinical Trials Registry

Identifier Type: REGISTRY

Identifier Source: secondary_id

SC discharge

Identifier Type: -

Identifier Source: org_study_id

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