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

NCT ID: NCT03879889

Last Updated: 2021-03-29

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2019-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Smoking, Tobacco

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
Research study personnel who will conduct the data collection on outcome measures will be blinded to the group assignment. The researchers who will conduct the data analysis will also be blinded the group assignment.

Study Groups

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Intervention

Intervention arm will include face-to-face counseling on smoking reduction and adherence to nicotine replacement therapy (NRT) with motivational interviews, provision of free NRT, referral to quit smoking hotline, monthly phone follow-up and two follow-up visits.

Group Type EXPERIMENTAL

Nicotine patch

Intervention Type DRUG

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.

Control

Smoking parents will be given standard advice on smoking cessation. They will be given an information leaflet showing standard information on the currently available smoking cessation service as well as a smoking cessation hotline.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Nicotinelle

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Kate Ching Ching Chan

Clinical Professional Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ching Ching Chan, FHKAM

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

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Prince of Wales Hospital

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

References

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Dai S, Chan MHM, Kam RKT, Li AM, Au CT, Chan KC. Monthly Motivational Interview Counseling and Nicotine Replacement Therapy for Smoking Parents of Pediatric Patients: A Randomized Controlled Trial. Front Pediatr. 2022 Apr 13;10:798351. doi: 10.3389/fped.2022.798351. eCollection 2022.

Reference Type DERIVED
PMID: 35498786 (View on PubMed)

Other Identifiers

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01150077

Identifier Type: -

Identifier Source: org_study_id

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