Smartphone App and CO Self-monitoring for Smoking Cessation

Phase 4

Terminated

• Conditions: Smoking; HIV
• Interventions: Other: Smartphone app/CO self-monitoring

• Registration Number: NCT02840513
• Lead Sponsor: Alain Nordmann

Brief Summary

This randomized controlled trial is going to evaluate whether an intervention consisting of a smartphone application to assist smokers living with HIV to quit in combination with CO self-monitoring compared to stop smoking counselling by physicians during usual care results in higher self-reported and biochemically verified smoking cessation rates at 6 months.

.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-19
• Study First Submitted QC: 2016-07-20
• Study First Posted: 2016-07-21
• Study Start: 2017-06-01
• Primary Completion: 2019-06-24
• Study Completion: 2019-06-24
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-08
• Last Update Posted: 2020-07-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

HIV-infected smokers ≥ 16 years and smoking ≥ 3 cigarettes /day enrolled into the Swiss HIV Cohort Study Willingness to quit smoking Speaking one or more of offical Swiss national languages or English Users of smartphone (specifically iPhone 5, 5c, 5s, 6, 6+ running iOS Version 8.0+; smartphones with resolution of at least 800x400 pixels running, Android Version 5.0+, and Android smartwatches) Informed consent

Exclusion Criteria

Limitations in hearing, comprehension or vision problems that preclude full study participation Participants with a life expectancy of less than 12 months due to any serious medical condition

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Smartphone app/CO self-monitoring	Smartphone app/CO self-monitoring	The app offers a coaching function where users receive personalized messages to encourage smoking cessation and advice for behavioural changes. For the first 4 weeks of the intervention, individuals will also be asked to blow daily into a breath carbon monoxide monitor before going to sleep. Depending on the results of the breath test, individualized messages will be delivered by the Smokelyzer feedback app to either enhance maintenance of abstinence or increase the motivation to quit. After the first 4 weeks, participants will use the breath carbon monoxide monitor at least twice a week until the end of the 6-month study. The app will react with positive feedback in individuals doing well with smoking cessation and messages to encourage individuals with difficulties quitting to smoke.

Primary Outcome Measures

Name	Time	Method
Self-reported abstinence biochemically verified by a carbon monoxide test in-person	6 months

Secondary Outcome Measures

Name	Time	Method
Differences in the number of daily cigarettes smoked from baseline to 6-month follow-up and point prevalence of abstinence (ie, no smoking in the past 7 days) at 6-month follow-up.	6 months

Trial Locations

Locations (1)

University Hospital of Basel; 🇨🇭 Basel, Switzerland