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

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ClinicalTrials.gov Identifier: NCT03879889
Recruitment Status : Recruiting
First Posted : March 19, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Kate Ching Ching Chan, Chinese University of Hong Kong

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

Condition or disease Intervention/treatment Phase
Smoking, Tobacco Drug: Nicotine patch Phase 4

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Smoking Reduction Intervention for Smoking Parents of Paediatric Patients in Hong Kong: a Randomised Controlled Trial
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : August 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
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.
Other Name: Nicotinelle

No Intervention: 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.



Primary Outcome Measures :
  1. Successful smoking reduction rate [ Time Frame: Week-24 ]
    successful smoking reduction rate is defined as a self-reported reduction of daily cigarette consumption by 50% or more compared with baseline


Secondary Outcome Measures :
  1. Change in urinary cotinine levels of the children from baseline [ Time Frame: Week-24 ]
    Change in urinary cotinine levels of the children from baseline, indicating an objective measure of tobacco smoke exposure

  2. Parental self-reported smoking reduction rate of cigarette consumption [ Time Frame: Week-24 ]
    Parental self-reported smoking reduction rate of cigarette consumption

  3. Parental self-reported smoking cessation rate of cigarette consumption [ Time Frame: Week-24 ]
    Parental self-reported 7-day point-prevalence tobacco abstinence

  4. Validated reduction and quit rate by parental urinary cotinine levels [ Time Frame: Week-24 ]
    Validated reduction and quit rate by parental urinary cotinine levels

  5. Validated quit rate by parental urinary cotinine levels [ Time Frame: Week-24 ]
    Validated quit rate by parental urinary cotinine levels

  6. Children's hospitalization rate [ Time Frame: Week-24 ]
    Children's hospitalization rate

  7. Rate of children's respiratory tract infection episodes [ Time Frame: Week-24 ]
    Rate of children's respiratory tract infection episodes

  8. Rate of children's sick visits [ Time Frame: Week-24 ]
    Rate of children's sick visits

  9. Children's spirometric measurement - FEV1 [ Time Frame: Week-24 ]
    Children's spirometric measurement - Forced expiratory volume in one second (FEV1)

  10. Children's spirometric measurement - FVC [ Time Frame: Week-24 ]
    Children's spirometric measurement - Forced vital capacity (FVC)



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03879889


Contacts
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Contact: Ching Ching Chan, FHKAM 35052849 katechan@cuhk.edu.hk

Locations
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Hong Kong
Prince of Wales Hospital Recruiting
Hong Kong, Hong Kong
Contact: Ching Ching Chan, FHKAM    35052849    katechan@cuhk.edu.hk   
Principal Investigator: Ching Ching Chan, FHKAM         
Sub-Investigator: Albert M Li, MD         
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: Ching Ching Chan, FHKAM Chinese University of Hong Kong

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Responsible Party: Kate Ching Ching Chan, Assistant Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03879889     History of Changes
Other Study ID Numbers: 01150077
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Kate Ching Ching Chan, Chinese University of Hong Kong:
Smoking reduction
Randomised controlled trial
Motivational interview
Nicotine replacement therapy
Environmental tobacco smoke exposure
Paediatrics
Children

Additional relevant MeSH terms:
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Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action