Smoking Cessation Program for the Elderly

Smoking Cessation Clinical Trial

Official title:

A Randomized 2 by 2 Factorial Trial on mHealth Support and Financial Incentives to Promote Smoking Cessation in Deprived Older Smokers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06234475
• Other study ID #: SCFE
• Status: Recruiting
• Phase: N/A
• Start date: February 20, 2024
• Est. completion date: November 2026

Study information

• Verified date: January 2024
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: November 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aged
• Motivation
• Smoking Cessation
• Telemedicine

Intervention

Behavioral:
• Mobile health support
Brief smoking cessation advice Health warning leaflet Smoking cessation information booklet Referral card E-messages on SC-related information and details on community SC services for 3 months Acceptance and Commitment Therapy based real-time Chat-based support for 3 months
• Financial incentive
Brief smoking cessation advice Health warning leaflet Smoking cessation information booklet Referral card 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.
• Combine intervention
Brief smoking cessation advice Health warning leaflet Smoking cessation information booklet Referral card E-messages on SC-related information and details on community SC services for 3 months Acceptance and Commitment Therapy based real-time Chat-based support for 3 months 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.
• Control group
Brief smoking cessation advice Health warning leaflet Smoking cessation information booklet Referral card E-messages on SC-related information and details on community SC services for 3 months for those without abstinence at 12-month follow-up after follow-ups ending Acceptance and Commitment Therapy based rear-time Chat-based support for 3 months for those without abstinence at 12-month follow-up after follow-ups ending

Locations

Country	Name	City	State
Hong Kong	School of Nursing, The University of Hong Kong	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The University of Hong Kong	University Grants Committee, Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The biochemically validated smoking abstinence	Smoking abstinence is defined by exhaled CO < 4 ppm and salivary cotinine <30 ng/ml	the 6-month follow-ups
Secondary	The biochemically validated smoking abstinence	Smoking abstinence is defined by exhaled CO < 4 ppm and salivary cotinine <30 ng/ml	the 3- and 12-month follow-ups
Secondary	Self-reported 7-day point-prevalence abstinence	Smokers who did not smoke even a puff in the 7 days preceding the follow-up	3-, 6-, and 12-month follow-ups
Secondary	Self-reported smoking change	Self-reported change in number of cigarettes smoked daily of at least less 50% of the baseline number	3-, 6-, and 12-month follow-ups
Secondary	Self-reported self-efficacy of quitting	Self-reported self-efficacy of quitting includes the perception of quitting importance, difficulty and confidence, assessing by an item scaled with 0-10, respectively. The score of zero refers to very unimportant, very easy, or very unconfident. The score of 10 refers to very important, very difficult or very confident, respectively. Higher score refers to higher perception of quitting importance, difficulty and confidence.	3-, 6-, and 12-month follow-ups
Secondary	Self-reported quit attempts	Self-reported quit attempt	3-, 6-, and 12-month follow-ups
Secondary	Nicotine dependence level	Fagerstrom Test for Nicotine Dependence (FTND)	3-, 6-, and 12-month follow-ups
Secondary	Smoking cessation services use	Using the smoking cessation service from hospitals or government in Hong Kong	3-, 6-, and 12-month follow-ups
Secondary	Self-reported intention to quit	self-reported intention to quit in next days	3-, 6-, and 12-month follow-ups