Smoking Reduction Intervention for Smoking Parents of Paediatric Patients in Hong Kong

Smoking, Tobacco Clinical Trial

Official title:

Smoking Reduction Intervention for Smoking Parents of Paediatric Patients in Hong Kong: a Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03879889
• Other study ID #: 01150077
• Status: Completed
• Phase: Phase 4
• Start date: February 1, 2017
• Est. completion date: July 31, 2019

Study information

• Verified date: March 2021
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A randomized controlled trial to evaluate the effectiveness of smoking reduction interventions for smoking parents in paediatric hospital setting in Hong Kong.

Description:

This is a single blinded randomized controlled trial aiming to evaluate the effectiveness of smoking reduction interventions for smoking parents in paediatric hospital setting in Hong Kong. This trial consists of a 24-week intervention period. Eligible families will be randomly assigned to either intervention group or control group. Smoking parent(s) in intervention group will be given face-to-face counselling on smoking reduction and adherence to nicotine replacement therapy (NRT) with motivational interviews, provision of NRT and monthly phone follow-up for counselling and support. Smoking parent(s) in control group will be given standard advice and information on smoking cessation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Ethnic Chinese family with children aged younger than 18 years of age.

• Children who are admitted to the paediatric inpatient units or attend the paediatric specialist clinic at the Prince of Wales Hospital.

• Children with at least one custodial smoking parent who is living with them.

• Written informed consent obtained from parents.

Exclusion Criteria:

• Families not residing in Hong Kong.

• Children in foster care.

• Children with unclear custody.

• Smoking paediatric patients.

• Presence of smoking household members apart from the parents.

• Smoking parent who is contraindicated to use nicotine replacement therapy.

Related Conditions & MeSH terms

• Smoking, Tobacco

Intervention

Drug:
• Nicotine patch
Four weeks of nicotine patch will be provided at the first contact, which will be prescribed using the guidelines based on the subject's daily cigarette consumption. At week-4 visit, four more weeks of NRT will be provided.

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validated successful smoking reduction rate	Urinary cotinine validated parental successful smoking reduction rate at week-24	Week-24
Primary	Self-reported parental successful smoking reduction rate at week-24	Self-reported reduction of daily cigarette consumption by 50% or more compared with baseline	Week-24
Secondary	Urinary cotinine validated parental smoking cessation rate at week-24	Urinary cotinine validated parental smoking cessation rate at week-24	Week-24
Secondary	Parental self-reported smoking reduction rate of cigarette consumption	Parental self-reported smoking reduction rate of cigarette consumption	Week-24
Secondary	Parental self-reported smoking cessation rate of cigarette consumption	Parental self-reported 7-day point-prevalence tobacco abstinence	Week-24
Secondary	Change in children's urinary cotinine level from baseline to week-24	Change in children's urinary cotinine level from baseline to week-24	Week-24