Smoking, TobaccoPhase 4NCT03879889
Smoking Reduction Intervention for Smoking Parents of Paediatric Patients in Hong Kong
A Phase 4 study testing Nicotine patch in people with Smoking, Tobacco, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
A randomized controlled trial to evaluate the effectiveness of smoking reduction interventions for smoking parents in paediatric hospital setting in Hong Kong. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Smoking, Tobacco
- What is being tested?
- Nicotine patch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Feb 2017to 31 Jul 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Smoking Reduction Intervention for Smoking Parents of Paediatric Patients in Hong Kong: a Randomised Controlled Trial
A randomized controlled trial to evaluate the effectiveness of smoking reduction interventions for smoking parents in paediatric hospital setting in Hong Kong.
Read the 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.
- Conditions
- Smoking, Tobacco
- Being tested
- Nicotine patch
- Keywords
- Smoking reduction, Randomised controlled trial, Motivational interview, Nicotine replacement therapy, Environmental tobacco smoke exposure, Paediatrics, Children
- Medical subject headings
- Tobacco Smoking, Smoking Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine patchDrug
Also called Nicotinelle
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Drug: Nicotine patch |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validated successful smoking reduction rate
Urinary cotinine validated parental successful smoking reduction rate at week-24
Measured: Week-24
Self-reported parental successful smoking reduction rate at week-24
Self-reported reduction of daily cigarette consumption by 50% or more compared with baseline
Measured: Week-24
Secondary outcomes (4)
Urinary cotinine validated parental smoking cessation rate at week-24
Urinary cotinine validated parental smoking cessation rate at week-24
Measured: Week-24
Parental self-reported smoking reduction rate of cigarette consumption
Parental self-reported smoking reduction rate of cigarette consumption
Measured: Week-24
Parental self-reported smoking cessation rate of cigarette consumption
Parental self-reported 7-day point-prevalence tobacco abstinence
Measured: Week-24
Change in children's urinary cotinine level from baseline to week-24
Change in children's urinary cotinine level from baseline to week-24
Measured: Week-24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start1 Feb 2017
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking, TobaccoStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kate Ching Ching Chan, Chinese University of Hong Kong
- Investigators
- Ching Ching Chan, FHKAM, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03879889
- Sponsor's protocol ID
- 01150077
- Status last verified
- Mar 2021
- First submitted
- 13 Mar 2019
- Last updated
- 29 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35498786
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoking Reduction Intervention for Smoking Parents of Paediatric Patients in Hong Kong: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03879889
- Acronym / sponsor ID
- 01150077
- Conditions
- Smoking, Tobacco
- Keywords
- Smoking reduction, Randomised controlled trial, Motivational interview, Nicotine replacement therapy, Environmental tobacco smoke exposure, Paediatrics, Children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 19 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized controlled trial to evaluate the effectiveness of smoking reduction interventions for smoking parents in paediatric hospital setting in Hong Kong.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Nicotine patchIntervention 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. |
| Control | No intervention | –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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotine patchAlso: NicotinelleFour 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. | Drug | Intervention |
Primary outcome
Validated successful smoking reduction rate
Time frame: Week-24
Urinary cotinine validated parental successful smoking reduction rate at week-24
Self-reported parental successful smoking reduction rate at week-24
Time frame: Week-24
Self-reported reduction of daily cigarette consumption by 50% or more compared with baseline
4 secondary outcomes
Urinary cotinine validated parental smoking cessation rate at week-24
Time frame: Week-24
Parental self-reported smoking reduction rate of cigarette consumption
Time frame: Week-24
Parental self-reported smoking cessation rate of cigarette consumption
Time frame: Week-24
Change in children's urinary cotinine level from baseline to week-24
Time frame: Week-24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2021.
- Derived from this study: PubMed 35498786Dai 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ching Ching Chan, FHKAM principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nicotine patch in people with Smoking, Tobacco, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validated successful smoking reduction rate (time frame: Week-24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03879889, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2021.