Smartphone App and CO Self-monitoring for Smoking Cessation (SMART-CO)

Support by Smartphone App and Carbon Monoxide Self-monitoring for Smoking Cessation: a Randomised Controlled Trial Nested Into the Swiss HIV Cohort Study

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.

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Study Overview

• Status: Terminated
• Conditions: Smoking; HIV
• Intervention / Treatment: Other: Smartphone app/CO self-monitoring

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Phase 4

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • University Hospital of Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Other: Smartphone app/CO self-monitoring; Smartphone app and carbon monoxide self-monitoring (personal device)
NO_INTERVENTION: Control; Participants in the control group will be managed according to usual care as regularly provided by their SHCS physicians. Physicians will motivate patients to quit, emphasise the advantage of quitting, and provide patients with an information card that contains short advices how to quit and addresses of stop smoking clinics. The Swiss HIV Cohort Study study nurse will enter past or current use as well as of nicotine replacement therapy or use of other pharmaceutical support to quit smoking in the online study form

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Self-reported abstinence biochemically verified by a carbon monoxide test in-person	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Alain Nordmann

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2017
• Primary Completion (ACTUAL): June 24, 2019
• Study Completion (ACTUAL): June 24, 2019

Study Registration Dates

• First Submitted: July 19, 2016
• First Submitted That Met QC Criteria: July 20, 2016
• First Posted (ESTIMATE): July 21, 2016

Study Record Updates

• Last Update Posted (ACTUAL): July 10, 2020
• Last Update Submitted That Met QC Criteria: July 8, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Smartphone app; CO self-monitoring
• Other Study ID Numbers: AN1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No