Telemedicine: Smoking Cessation App OnlyNCT03689140
Mobile Health Intervention for Family Smoking Cessation in Romania
A study testing Smoke Free Together - App-only, Smoke Free Together - Telemedicine counseling only and Smoke Free Together - app + telemedicine in people with Telemedicine: Smoking Cessation App Only and Telemedicine: Smoking Cessation Counseling, run by Michigan State University at 1 site in Romania.
Trial summary
The objectives of this study are to determine in a randomized controlled trial (RCT) whether a mobile health (mHealth) couples intervention shows promise in increasing smoking cessation among pregnant couples who smoke and to build mHealth research capacity in Romania. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Telemedicine: Smoking Cessation App Only, Telemedicine: Smoking Cessation Counseling, Telemedicine: App + Counseling
- What is being tested?
- Smoke Free Together - App-only, Smoke Free Together - Telemedicine counseling only and Smoke Free Together - app + telemedicine
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- 1 siteRomania
- Study dates
- 28 Jan 2019to 24 Aug 2020
- Phase
- Interventional
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- pregnant smokers in the 2nd or 3rd pregnancy trimester and their partners.
- 18 years or older
- married or in a stable relationship
- owns and uses an Android smartphone with broadband internet connection
- willing to have the partner contacted for participation.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
The objectives of this study are to determine in a randomized controlled trial (RCT) whether a mobile health (mHealth) couples intervention shows promise in increasing smoking cessation among pregnant couples who smoke and to build mHealth research capacity in Romania. The intervention will be novel in its use of the unique functionality of smartphones, its emphasis on the dyadic efficacy for smoking cessation, and the focus on pregnant couples. Our aims are to (1) Test the implementation feasibility, acceptability, and initial efficacy of a culturally-adapted mHealth smoking cessation intervention among couples during pregnancy and postpartum in Romania. (2) Develop mHealth research capacity by enhancing individual and institutional research capabilities in Romania and expanding the existing international research network.
- Conditions
- Telemedicine: Smoking Cessation App Only, Telemedicine: Smoking Cessation Counseling, Telemedicine: App + Counseling, Usual Care
- Being tested
- Smoke Free Together - App-only, Smoke Free Together - Telemedicine counseling only, Smoke Free Together - app + telemedicine
- Keywords
- mHealth, Mobile health, Telehealth, Pregnancy, Tobacco, Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoke Free Together - App-onlyBehavioural
Pregnant smokers and their life partners will use a smoking cessation app.
Smoke Free Together - Telemedicine counseling onlyBehavioural
Pregnant smokers and their life partners will use telemedicine, real time video counseling on smoking cessation
Smoke Free Together - app + telemedicineBehavioural
Pregnant smokers and their life partners will use telemedicine and an app for smoking cessation
| Study group | Role | What they receive |
|---|---|---|
| App-only | Experimental | The intervention will consist of participants will only use a smoking cessation app Receives: Behavioral: Smoke Free Together - App-only |
| Telemedicine counseling only | Experimental | The intervention will consist of participants will only use telemedicine counseling Receives: Behavioral: Smoke Free Together - Telemedicine counseling only |
| App + telemedicine counseling | Experimental | The intervention will consist of participants will only use a smoking cessation app + telemedicine counseling Receives: Behavioral: Smoke Free Together - app + telemedicine |
| Usual Care | No intervention | The participants will continue with usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of women in each arm who stopped smoking, and who relapsed smoking postpartum
The primary outcomes are maternal pregnancy smoking cessation and postnatal relapse. Maternal smoking status will be biochemically verified at the final follow-up based on salivary cotinine obtained by mail.
Measured: Change from smoking at baseline to quitting assessed at 3 months after the intervention is completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study start28 Jan 2019
- Primary completion24 Aug 2020
- Study completion24 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Telemedicine: Smoking Cessation App OnlyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Collaborators
- Babes-Bolyai University, University of Michigan, Wake Forest University Health Sciences
- Responsible party
- Principal investigator, Cristian Meghea, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03689140
- Sponsor's protocol ID
- 1R21TW010896
- Status last verified
- Apr 2022
- First submitted
- 19 Sep 2018
- Last updated
- 21 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Health Intervention for Family Smoking Cessation in Romania
- ClinicalTrials.gov ID
- NCT03689140
- Acronym / sponsor ID
- 1R21TW010896
- Conditions
- Telemedicine: Smoking Cessation App Only, Telemedicine: Smoking Cessation Counseling, Telemedicine: App + Counseling, Usual Care
- Keywords
- mHealth, Mobile health, Telehealth, Pregnancy, Tobacco, Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Collaborators
- Babes-Bolyai University, University of Michigan, Wake Forest University Health Sciences
- Study start
- 28 Jan 2019 (actual)
- Primary completion
- 24 Aug 2020 (actual)
- Study completion
- 24 Aug 2020 (actual)
- First posted
- 28 Sep 2018 (actual)
- 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.
The objectives of this study are to determine in a randomized controlled trial (RCT) whether a mobile health (mHealth) couples intervention shows promise in increasing smoking cessation among pregnant couples who smoke and to build mHealth research capacity in Romania. The intervention will be novel in its use of the unique functionality of smartphones, its emphasis on the dyadic efficacy for smoking cessation, and the focus on pregnant couples. Our aims are to (1) Test the implementation feasibility, acceptability, and initial efficacy of a culturally-adapted mHealth smoking cessation intervention among couples during pregnancy and postpartum in Romania. (2) Develop mHealth research capacity by enhancing individual and institutional research capabilities in Romania and expanding the existing international research network.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| App-only | Experimental | Behavioral: Smoke Free Together - App-onlyThe intervention will consist of participants will only use a smoking cessation app |
| Telemedicine counseling only | Experimental | Behavioral: Smoke Free Together - Telemedicine counseling onlyThe intervention will consist of participants will only use telemedicine counseling |
| App + telemedicine counseling | Experimental | Behavioral: Smoke Free Together - app + telemedicineThe intervention will consist of participants will only use a smoking cessation app + telemedicine counseling |
| Usual Care | No intervention | –The participants will continue with usual care |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- pregnant smokers in the 2nd or 3rd pregnancy trimester and their partners.
- 18 years or older
- married or in a stable relationship
- owns and uses an Android smartphone with broadband internet connection
- willing to have the partner contacted for participation.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Smoke Free Together - App-onlyPregnant smokers and their life partners will use a smoking cessation app. | Behavioural | App-only |
| Smoke Free Together - Telemedicine counseling onlyPregnant smokers and their life partners will use telemedicine, real time video counseling on smoking cessation | Behavioural | Telemedicine counseling only |
| Smoke Free Together - app + telemedicinePregnant smokers and their life partners will use telemedicine and an app for smoking cessation | Behavioural | App + telemedicine counseling |
Primary outcome
Percentage of women in each arm who stopped smoking, and who relapsed smoking postpartum
Time frame: Change from smoking at baseline to quitting assessed at 3 months after the intervention is completed
The primary outcomes are maternal pregnancy smoking cessation and postnatal relapse. Maternal smoking status will be biochemically verified at the final follow-up based on salivary cotinine obtained by mail.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
- Individual participant dataSharing planned: No
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 study testing Smoke Free Together - App-only, Smoke Free Together - Telemedicine counseling only and Smoke Free Together - app + telemedicine in people with Telemedicine: Smoking Cessation App Only and Telemedicine: Smoking Cessation Counseling, run by Michigan State University at 1 site in Romania.
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 5 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: finished, as of the sponsor's last update on 21 Apr 2022. 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 Romania. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of women in each arm who stopped smoking, and who relapsed smoking postpartum (time frame: Change from smoking at baseline to quitting assessed at 3 months after the intervention is completed). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Apr 2022.