Clinical trial NCT06234475: Smoking Cessation Program for the Elderly
Official title: A Randomized 2 by 2 Factorial Trial on mHealth Support and Financial Incentives to Promote Smoking Cessation in Deprived Older Smokers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Smoking Cessation
Aged
Telemedicine
Motivation
Keywords: Smoking Cessation
Low-income older smokers
Mobile health
Incentive
Real-time personalized support
Factorial study
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: University Grants Committee, Hong Kong
First posted: 2024-01-31
Enrollment: 1200
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This study aims to assess the effect of mobile health (mHealth) support or financial incentives and their interactive intervention effect on smoking cessation (SC) in old smokers in Hong Kong (HK).

Detailed description: Low-income older smokers are disproportionally harmed by tobacco use and the evidence of effectiveness of smoking cessation (SC) intervention for this deprived group is scarce. Leveraging evidence of effectiveness of mHealth support and financial incentives in other adults, the investigators propose a scalable mHealth and/or financial incentives model using age-friendly components for the deprived older smokers.

The 2x2 factorial design consists of 2 interventions, including (1) smartphone mHealth support by scheduled age-friendly multimedia e-messages and real-time personalized behavioral supports for 3 months, and (2) an escalating incentive scheme for smoking abstinence: HK$500 for using any SC services within 6 months, and HK$1000, 1500 and 2000 for biochemically validated abstinence at 3-, 6- and 12-month, respectively.

The study aims to assess the effectiveness of two interventions and their interactive intervention effect.

Eligibility criteria: Inclusion Criteria:

1. Smokers aged 60 years or above;
2. Currently smoking cigarettes or alternative tobacco products daily in the past 3 months with an exhaled carbon monoxide (CO) level ≥4ppm or salivary cotinine \>30 ng/ml;
3. Have a mobile phone that can receive short message/messaging Service (SMS) or instant messages (IM);
4. Having a household monthly income lower than the median income of domestic household in Hong Kong

6. Hong Kong residents able to communicate in Chinese.

Exclusion Criteria:

1. Smokers not physically nor mentally fit for communication;
2. Smokers currently using SC services;
3. Hospitalized smokers;
4. Not having a mobile phone or perceived difficulty in using mobile phone or communication Apps

Primary outcomes:
measure: The biochemically validated smoking abstinence
timeFrame: the 6-month follow-ups
Secondary outcomes:
measure: The biochemically validated smoking abstinence
timeFrame: the 3- and 12-month follow-ups
measure: Self-reported 7-day point-prevalence abstinence
timeFrame: 3-, 6-, and 12-month follow-ups
measure: Self-reported smoking change
timeFrame: 3-, 6-, and 12-month follow-ups
measure: Self-reported self-efficacy of quitting
timeFrame: 3-, 6-, and 12-month follow-ups
measure: Self-reported quit attempts
timeFrame: 3-, 6-, and 12-month follow-ups
measure: Nicotine dependence level
timeFrame: 3-, 6-, and 12-month follow-ups
measure: Smoking cessation services use
timeFrame: 3-, 6-, and 12-month follow-ups
measure: Self-reported intention to quit
timeFrame: 3-, 6-, and 12-month follow-ups
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: School of Nursing, The University of Hong Kong
Study officials:
References: