SmokingPhase 4SMART-CONCT02840513
Smartphone App and CO Self-monitoring for Smoking Cessation
A Phase 4 study testing Smartphone app/CO self-monitoring in people with Smoking and HIV, run by Alain Nordmann at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older
- What is being tested?
- Smartphone app/CO self-monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jun 2017to 24 Jun 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
.
- Being tested
- Smartphone app/CO self-monitoring
- Keywords
- Smartphone app, CO self-monitoring
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone app/CO self-monitoringOther
Smartphone app and carbon monoxide self-monitoring (personal device)
| Study group | Role | What they receive |
|---|---|---|
| Smartphone app/CO self-monitoring | Experimental | 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. Receives: Other: Smartphone app/CO self-monitoring |
| Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Self-reported abstinence biochemically verified by a carbon monoxide test in-person
Measured: 6 months
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study start1 Jun 2017
- Primary completion24 Jun 2019
- Study completion24 Jun 2019
Why it stopped: Due to insufficient patient recruitment and lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alain Nordmann
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alain Nordmann, Basel Institute for Clinical Epidemiology and Biostatistics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02840513
- Sponsor's protocol ID
- AN1
- Acronym
- SMART-CO
- Status last verified
- Jul 2020
- First submitted
- 19 Jul 2016
- Last updated
- 10 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mdege ND, Shah S, Dogar O, Pool ER, Weatherburn P, Siddiqi K, Zyambo C, Livingstone-Banks J. Interventions for tobacco use cessation in people living with HIV. Cochrane Database Syst Rev. 2024 Aug 5;8(8):CD011120. doi: 10.1002/14651858.CD011120.pub3.
PubMed 39101506
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Support by Smartphone App and Carbon Monoxide Self-monitoring for Smoking Cessation: a Randomised Controlled Trial Nested Into the Swiss HIV Cohort Study
- ClinicalTrials.gov ID
- NCT02840513
- Acronym / sponsor ID
- SMART-CO / AN1
- Keywords
- Smartphone app, CO self-monitoring
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to insufficient patient recruitment and lack of funding
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Alain NordmannUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 24 Jun 2019 (actual)
- Study completion
- 24 Jun 2019 (actual)
- First posted
- 21 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smartphone app/CO self-monitoring | Experimental | Other: Smartphone app/CO self-monitoringThe 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. |
| Control | No intervention | –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 |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartphone app/CO self-monitoringSmartphone app and carbon monoxide self-monitoring (personal device) | Other | Smartphone app/CO self-monitoring |
Primary outcome
Self-reported abstinence biochemically verified by a carbon monoxide test in-person
Time frame: 6 months
1 secondary outcome
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.
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Due to insufficient patient recruitment and lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2020.
- Derived from this study: PubMed 39101506Mdege ND, Shah S, Dogar O, Pool ER, Weatherburn P, Siddiqi K, Zyambo C, Livingstone-Banks J. Interventions for tobacco use cessation in people living with HIV. Cochrane Database Syst Rev. 2024 Aug 5;8(8):CD011120. doi: 10.1002/14651858.CD011120.pub3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Smartphone app/CO self-monitoring in people with Smoking and HIV, run by Alain Nordmann at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Due to insufficient patient recruitment and lack of funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported abstinence biochemically verified by a carbon monoxide test in-person (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02840513, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2020.