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The project aims to develop and examine the feasibility, acceptability, and preliminary effectiveness of a proactive intervention model combined brief advice, nicotine replacement therapy sampling and mHealth-based individual counselling in increasing smoking abstinence for fathers of sick children.
Targeted participants are fathers of sick children who smoke daily in the past 7 days and live together with their children. The primary caregiver will be selected if both parents smoke. Participants will be recruited from pediatric wards/outpatient departments of Queen Mary Hospital (QMH), a major acute hospital in Hong Kong. The recruitment will be extended to other public hospitals if needed.
This study will be a two-arm, parallel pilot randomized trial with follow-ups at 1-, 3-, and 6-month since enrolment using standard methodology (CONSORT) to evaluate the effectiveness of the intervention. Surveys will be collected via telephone and children's saliva will be collected face-to-face at 3-months and 6-months after randomisation using Alere iScreen OFD saliva cotinine test device. Semi-structured individual telephone or face-to-face in-depth interviews will be conducted with the participants in the intervention group at 6 months follow-up to explore the participants' perception towards the intervention.
This study's clinical outcome will be biochemically validated abstinence at 3 months after randomisation. Secondary outcomes include validated abstinence at 6 months after randomisation, self-reported 7-day point prevalence abstinence (PPA), 24-hour quit attempts, and smoking reduction by at least 50% at 3 and 6 months. Incentives of HK$200 will be given to participants who report 7-day PPA at 1 month post randomisation. Additionally, incentives of HK$ 500 will be provided for the completion of each biochemical validation (a total $1000 for validation at 3- and 6-month). Such an amount can increase the response rate in our experience. Another incentive of $200 will be given to subjects completing qualitative interviews.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | A 1-week free sample of NRT patch or gum will be provided to encourage quit attempt without the pressure of quitting successfully. mHealth messages will be provided to motivate and support quitting and improve the protection measured of SHS exposure for children throughout the intervention period of 3 months. |
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| Control group | Active Comparator | Participants in the control group will only receive brief advice on SHS protective measures. Self-help materials will also be provided without follow-up interventions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine Replacement Therapy (NRT) Sampling | Behavioral | Participants will be advised to choose the NRT according to their preferences and daily cigarette consumption. Cigarette consumption of ≤20 daily will receive the 14mg patch or 2mg gum and participants consume >20 cigarettes daily will receive the 21mg patch. An NRT use card (Appendix 6 draft) containing the instructions and potential side effects were given with a brief oral explanation. Full course of pharmacological treatment for 12-week are available in smoking cessation services. Participants requesting for additional or full course of NRT will be actively refer to the respective services as part of the Referral step in the AWARD model (Ask, Warn, Advise, Refer, and Do-it-again). |
| Measure | Description | Time Frame |
|---|---|---|
| Biochemically validated abstinence | Face-to-face biochemical validation using Alere iScreen OFD saliva cotinine test device | 3-months follow-ups |
| Measure | Description | Time Frame |
|---|---|---|
| Biochemically validated abstinence | Face-to-face biochemical validation using Alere iScreen OFD saliva cotinine test device | 6-month follow-up |
| Past 7-day point prevalence abstinence (PPA) | Past 7-day PPA will be measured by a self-reported question: Have you ever smoked in the past 7 days? |
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Inclusion criteria for parents：
Exclusion criteria for parents
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shengzhi Zhao, PhD | Contact | +852 6561 4500 | lubabezz@connect.hku.hk | |
| Mengyao Li, MPhil | Contact | +852 6851 8462 | lmy0814@connect.hku.hk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Nursing, The University of Hong Kong | Recruiting | Hong Kong | Pokfulam | 999077 | Hong Kong |
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| ID | Term |
|---|---|
| D000073865 | Cigarette Smoking |
| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
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| ID | Term |
|---|---|
| D000095488 | Nicotine Replacement Therapy |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| mHealth-based motivational counselling | Behavioral | The mHealth intervention will be delivered via the most popular instant messaging app in Hong Kong (WhatsApp). A total of 24 messages with contents including the harms of smoking and smoke exposure for children, encouragement, benefits of quitting for children, methods of quitting, dealing with craving, and measures to reduce cigarette smoke exposure at home will be provided. The messages will be scheduled in a tapering schedule that participants will receive 5 messages in the first week, then cut down to 3 messages/week for the next 4 weeks and 1 message/week for the last 7 weeks. Using a more personalized approach, the messages will be tailored to the participants' motivation, intention to quit and other quitting patterns collected at baseline. Real-time conversations could be initiated by participants themselves, triggered by regular messages, or through prompt inquires (e.g., asking about the quitting progress). |
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| Brief cessation advice and self-help material | Behavioral | At baseline, participants will receive brief face-to-face advice on quitting smoking for the health of the children using the validated AWARD model (Ask, Warn, Advise, Refer, Do-it-again) with a print-based self-help material providing detailed information on health hazards of SHS exposure on children, methods to deal with craving and withdrawal symptoms, and measures on preventing SHS exposure for children at home. |
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| 3-month follow-up |
| Past 7-day point prevalence abstinence (PPA) | Past 7-day PPA will be measured by a self-reported question: Have you ever smoked in the past 7 days? | 6-month follow-up |
| Smoking reduction | 50% or above reduction in cigarette consumption compared with baseline | 3-month follow-up |
| Smoking reduction | 50% or above reduction in cigarette consumption compared with baseline | 6-month follow-up |
| Use of smoking cessation services | Use of smoking cessation services will be measured by a self-reported question: Have you ever used smoking cessation services in the past 7 days? | 3-month follow-up |
| Use of smoking cessation services | Use of smoking cessation services will be measured by a self-reported question: Have you ever used smoking cessation services in the past 7 days? | 6-month follow-up |
| Respiratory symptoms | Respiratory symptoms will be measured by a self-reported question: Have you ever experienced respiratory symptoms in the past 7 days? If yes, please list. | 3-month follow-up |
| Respiratory symptoms | Respiratory symptoms will be measured by a self-reported question: Have you ever experienced respiratory symptoms in the past 7 days? If yes, please list. | 6-month follow-up |
| Perceived family well-being | Perceived family well-being will be measured by the Family Apgar Scale. The total scale ranges from 0 to 10, with the higher score indicating a healthier family function. | 3-month follow-up |
| Perceived family well-being | Perceived family well-being will be measured by the Family Apgar Scale. The total scale ranges from 0 to 10, with the higher score indicating a healthier family function. | 6-month follow-up |
| Self-reported life quality | Quality of life will be measured by the WHOQoL scale. The total score ranges 0 to 100, with higher scores indicates better quality of life. | 3-month follow-up |
| Self-reported life quality | Quality of life will be measured by the WHOQoL scale. The total score ranges 0 to 100, with higher scores indicates better quality of life. | 6-month follow-up |
| Self-reported secondhand exposure | Self-reported secondhand exposure by children in the past 7 days (yes/no). If yes, we will ask where you are exposed to secondhand smoke and when you are exposed to secondhand smoke. | 3-month follow-up |
| Self-reported secondhand exposure | Self-reported secondhand exposure by children in the past 7 days (yes/no). If yes, we will ask where you are exposed to secondhand smoke and when you are exposed to secondhand smoke. | 6-month follow-up |
| Self-reported thirdhand exposure | Self-reported thirdhand exposure by children in the past 7 days (yes/no). If yes, we will ask where you are exposed to thirdhand smoke and when you are exposed to thirdhand smoke. | 3-month follow-up |
| Self-reported thirdhand exposure | Self-reported thirdhand exposure by children in the past 7 days (yes/no). If yes, we will ask where you are exposed to thirdhand smoke and when you are exposed to thirdhand smoke. | 6-month follow-up |