mHealth-based Motivational Counselling Integrate With a Sample of Nicotine Replacement Therapy for Fathers of Sick Children Who Smoke Cigarettes: A Pilot Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- The University of Hong Kong
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- Biochemically validated abstinence
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •for parents：
- •Parents (mainly fathers) aged ≥18 years and smoke at least one cigarette (including alternative tobacco products) daily in the past seven days
- •Living with a child aged <18 years who attended the clinic or were admitted to the pediatric ward
- •Hong Kong residents able to read and communicate in Cantonese or Putonghua
- •Owned a smartphone and can use an instant messaging app (e.g., WhatsApp, Facebook) Inclusion criteria for children
- •Children aged <18 years who attended the clinic or were admitted to the pediatric ward
- •Lives with at least one or more parents who smoke at least one cigarette (including alternative tobacco products) daily in the past seven days
- •Able to provide biochemical samples (e.g. saliva) for purpose of research
Exclusion Criteria
- •for parents
- •Smokers having a history of psychiatric/psychological disease or currently on regular psychotropic medications
- •Smokers using smoking cessation medications or other smoking cessation services or projects Exclusion criteria for children
- •Children who already have serious health diseases (e.g.chronic disease, genetic disease)
- •Children who are participating in other clinical trials that may affect the results of this study
- •Children who live in certain environments, such as those living in highly contaminated areas or areas with other potential disease-causing factors
Arms & Interventions
Intervention group
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.
Intervention: mHealth-based motivational counselling (Behavioral)
Intervention group
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.
Intervention: Brief cessation advice and self-help material (Behavioral)
Control group
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.
Intervention: Brief cessation advice and self-help material (Behavioral)
Intervention group
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.
Intervention: Nicotine Replacement Therapy (NRT) Sampling (Behavioral)
Outcomes
Primary Outcomes
Biochemically validated abstinence
Time Frame: 3-months follow-ups
Face-to-face biochemical validation using Alere iScreen OFD saliva cotinine test device
Secondary Outcomes
- Biochemically validated abstinence(6-month follow-up)
- Past 7-day point prevalence abstinence (PPA)(6-month follow-up)
- Smoking reduction(6-month follow-up)
- Use of smoking cessation services(6-month follow-up)
- Respiratory symptoms(6-month follow-up)
- Perceived family well-being(6-month follow-up)
- Self-reported life quality(6-month follow-up)
- Self-reported secondhand exposure(6-month follow-up)
- Self-reported thirdhand exposure(6-month follow-up)
- Past 7-day point prevalence abstinence (PPA)(3-month follow-up)
- Smoking reduction(3-month follow-up)
- Use of smoking cessation services(3-month follow-up)
- Respiratory symptoms(3-month follow-up)
- Perceived family well-being(3-month follow-up)
- Self-reported life quality(3-month follow-up)
- Self-reported secondhand exposure(3-month follow-up)
- Self-reported thirdhand exposure(3-month follow-up)