NCT05430789

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
770

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 24, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

June 24, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

July 19, 2022

Status Verified

July 1, 2022

Enrollment Period

1.9 years

First QC Date

June 19, 2022

Last Update Submit

July 15, 2022

Conditions

Keywords

Behavioral change techniquesSmoking cessationMobile health technologyNurse-led interventionPost-dischargeDischarged patients

Outcome Measures

Primary Outcomes (2)

  • Biochemically-validated abstinence

    Defined by exhaled carbon monoxide \< 4 parts per million (ppm) and salivary cotinine \< 30 ng/ml

    6-month after baseline

  • Biochemically-validated abstinence

    Defined by exhaled carbon monoxide \< 4 parts per million (ppm) and salivary cotinine \< 30 ng/ml

    12-month after baseline

Secondary Outcomes (14)

  • Self-reported past 7-day abstinence

    6-month after baseline

  • Self-reported past 7-day abstinence

    12-month after baseline

  • 24-weeks continuous abstinence

    6-month after baseline

  • 24-weeks continuous abstinence

    12-month after baseline

  • Intention to quit

    6-month after baseline

  • +9 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Behavioral: 5As brief adviceBehavioral: Self-help e-bookletBehavioral: Nurse-led mHealth intervention

Control group

ACTIVE COMPARATOR

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

Behavioral: 5As brief adviceBehavioral: Self-help e-bookletBehavioral: Regular intervention

Interventions

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.

Control groupIntervention group

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.

Control groupIntervention group

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 group

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.

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Smokers who are hospitalised or waiting for discharge in Hong Kong
  • Smoke cigarettes or alternative tobacco products (e.g. electronic cigarettes or heated tobacco products) daily at 1 month prior to hospitalisation
  • Have a smartphone with an IM app (WhatsApp or WeChat) and experience in using the app
  • Hong Kong adult residents (18+) able to communicate in Chinese (Cantonese or Mandarin)

You may not qualify if:

  • Smokers not mentally fit for communication (e.g. psychiatry patients)
  • Smokers currently using SC medication or other SC services
  • Smokers hospitalised for more than 1 month
  • Perceived difficulty to use IM after discharge

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Nursing, The University of Hong Kong

Hong Kong, Hong Kong, China

RECRUITING

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Man Ping Wang, PhD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Man Ping Wang, PhD

CONTACT

Yingpei Zeng, MNurs

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 19, 2022

First Posted

June 24, 2022

Study Start

June 24, 2022

Primary Completion

May 31, 2024

Study Completion

September 30, 2024

Last Updated

July 19, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations