Explore Successful Method to Quit SmokingNCT03108651
Mobile Motivational Messages for Change (3M4Chan) Intervention in TMU
A study testing Case in people with Explore Successful Method to Quit Smoking, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
About 100 (50 from TMU Hospital and 50 from Wellcome Clinic) current smokers will be recruited who contact smoke cession clinics in teaching hospitals of Taipei Medical University (TMU) and Wellcome Clinic. They will be randomly assigned either to Usual Care (UC) or Usual Care plus 3M4Chan Intervention group (IG). Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Explore Successful Method to Quit Smoking
- What is being tested?
- Case
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2017to 15 Mar 2019
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 20 years or older and approach smoke cessation clinic at TMU hospital
- Have an Android mobile phone
- Able to read Traditional Chinese
- Willing to participate in all study components
- Willing to be followed-up for 6 months
- Smoked at least once every month in the last two years
- Current smoker
Who cannot join
- • Below 20 years on the day of enrolment
- Not willing to participate in the study
- Those who do not have Android mobile phone or unable to read Mandarin
- Not willing to share medical information from EHR
- Subjects who develop adverse effects related to the pharmacological treatment included in the study
Trial locations and contacts
1 site in 1 country.
About this study
About 100 (50 from TMU Hospital and 50 from Wellcome Clinic) current smokers will be recruited who contact smoke cession clinics in teaching hospitals of Taipei Medical University (TMU) and Wellcome Clinic. They will be randomly assigned either to Usual Care (UC) or Usual Care plus 3M4Chan Intervention group (IG). A randomized comparative effectiveness trial will be conducted. Patient will enroll from September 2017 to May 2018. In UC group, the physician provides a brief advice to quit during first consultation, a quit plan template, and medication prescription (Varenicline, Bupropion, Champix, Nicotinell TTS20) as decided by the physician. IG group includes UC plus a mobile App that is programmed to push tailored messages for health concern and readiness to quit, tips for sustaining abstinence, use of interactive self-assessments, helpful cessation information. This group of smokers will benefit from tailored cessation interventions with integrated body weight management elements that take into consideration the prevailing local and cultural influences on diet and levels of physical activity. IG will be continued even after stopping of the UC.
- Being tested
- Case
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaseOther
Motivational message will be administrated.
| Study group | Role | What they receive |
|---|---|---|
| Case | Active comparator | Motivational message will be administrated. Receives: Other: Case |
| Control | No intervention | Motivational message will not be administrated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking cessation rate at two months
Smoking cessation rate will be measured as the ratio of the total number of patients who relapsed with total number of patients in their group. Patients will be considered to have relapsed if they fail at least one of their urine cotinine and carbon monoxide tests.
Measured: Up to 2 months
Smoking cessation rate at four months
Smoking cessation rate will be measured as the ratio of the total number of patients who relapsed with total number of patients in their group. Patients will be considered to have relapsed if they fail at least one of their urine cotinine and carbon monoxide tests.
Measured: Up to 4 months
Smoking cessation rate at six months
Smoking cessation rate will be measured as the ratio of the total number of patients who relapsed with total number of patients in their group. Patients will be considered to have relapsed if they fail at least one of their urine cotinine and carbon monoxide tests.
Measured: Up to 6 months
Secondary outcomes (14)
User engagement at an individual level
Engagement at individual level will be assessed based on the rate of read messages by the patients. This is calculated as the quotient between the messages the patients have read, and the total number of messages the system has sent to the patients. This metric will be assessed throughout the observation until its end.
Measured: Up to 6 months
Engagement at aggregated level - Mobile application rolling retention
The percentage of users still active N days after installation. This is a ratio of the number of users whose last day of activity is past day N to the number of users who could have been active on day N. This metric will be assessed throughout the observation until its end.
Measured: Up to 6 months
Engagement at aggregated level - Mobile application session length distribution
The session length is defined as the length of time between the start of the application event and the end of the application event. The session length determines the engagement as it is relevant to know how much time patients spend in the app per session. This metric will be assessed throughout the observation until its end.
Measured: Up to 6 months
Engagement at aggregated level - Mobile application session frequency
The session frequency is a measure of how often each unique patient used the app within a given time interval. This metric will be assessed throughout the observation until its end.
Measured: Up to 6 months
Engagement at aggregated level - Mobile application sessions per user
A session is one use of the mobile application by a patient. This begins when the application is launched and ends when the application is terminated. This metric will be assessed throughout the observation until its end.
Measured: Up to 6 months
Engagement at aggregated level - Mobile application return rate
Return rate measures the percentage of patients who return to the app on a specific time after installation. It is measured by cohort group - that is, based on when patients first opened the app. It is calculated as the ratio of the number of users active on a given period to the size of the cohort. This metric will be assessed throughout the observation until its end.
Measured: Up to 6 months
User quitting attempts
Number of quitting attempts per patient, including the frequency of the quitting attempts.
Measured: Up to 6 months
User app behavior
It will be measured as the time spent per app section.
Measured: Up to 6 months
User satisfaction with messages
Patients' answers to a satisfaction questionnaire that will be handed to them at the end of the study.
Measured: At 6 months after enrolment.
User message ratings
User's votes for each message in a 5 star scale.
Measured: Up to 6 months
User lifestyle feedback
Comparison of changes in user lifestyle (at baseline and after 6 months) through the combined questionnaire EQ-5D-5L.
Measured: At enrollment and at 6 months after enrollment
User lifestyle feedback
Comparison of changes in user lifestyle (at baseline and after 6 months) through the combined questionnaire IPAQ for physical activity.
Measured: At enrollment and at 6 months after enrollment
User lifestyle feedback
Comparison of changes in user lifestyle (at baseline and after 6 months) through the combined questionnaires SF-36.
Measured: At enrollment and at 6 months after enrollment
Physical activity
The physical activity would be measured as the total time (minutes) of activity per user, retrieved by GoogleFit in the app.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start1 Sep 2017
- Primary completion2 Mar 2019
- Study completion15 Mar 2019
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 Explore Successful Method to Quit SmokingStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention study with two parallel arms.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shabbir Syed Abdul, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03108651
- Sponsor's protocol ID
- N201702069
- Status last verified
- Apr 2019
- First submitted
- 24 Mar 2017
- Last updated
- 10 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hors-Fraile S, Malwade S, Spachos D, Fernandez-Luque L, Su CT, Jeng WL, Syed-Abdul S, Bamidis P, Li YJ. A recommender system to quit smoking with mobile motivational messages: study protocol for a randomized controlled trial. Trials. 2018 Nov 9;19(1):618. doi: 10.1186/s13063-018-3000-1.
PubMed 30413176
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Motivational Messages for Change (3M4Chan) Intervention in TMU
- ClinicalTrials.gov ID
- NCT03108651
- Acronym / sponsor ID
- N201702069
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 2 Mar 2019 (actual)
- Study completion
- 15 Mar 2019 (actual)
- First posted
- 11 Apr 2017 (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.
About 100 (50 from TMU Hospital and 50 from Wellcome Clinic) current smokers will be recruited who contact smoke cession clinics in teaching hospitals of Taipei Medical University (TMU) and Wellcome Clinic. They will be randomly assigned either to Usual Care (UC) or Usual Care plus 3M4Chan Intervention group (IG). A randomized comparative effectiveness trial will be conducted. Patient will enroll from September 2017 to May 2018. In UC group, the physician provides a brief advice to quit during first consultation, a quit plan template, and medication prescription (Varenicline, Bupropion, Champix, Nicotinell TTS20) as decided by the physician. IG group includes UC plus a mobile App that is programmed to push tailored messages for health concern and readiness to quit, tips for sustaining abstinence, use of interactive self-assessments, helpful cessation information. This group of smokers will benefit from tailored cessation interventions with integrated body weight management elements that take into consideration the prevailing local and cultural influences on diet and levels of physical activity. IG will be continued even after stopping of the UC.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Intervention study with two parallel arms.
| Arm | Type | Receives |
|---|---|---|
| Case | Active comparator | Other: CaseMotivational message will be administrated. |
| Control | No intervention | –Motivational message will not be administrated. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 20 years or older and approach smoke cessation clinic at TMU hospital
- Have an Android mobile phone
- Able to read Traditional Chinese
- Willing to participate in all study components
- Willing to be followed-up for 6 months
Key exclusion criteria (5 listed)
- • Below 20 years on the day of enrolment
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 |
|---|---|---|
| CaseMotivational message will be administrated. | Other | Case |
Primary outcome
Smoking cessation rate at two months
Time frame: Up to 2 months
Smoking cessation rate will be measured as the ratio of the total number of patients who relapsed with total number of patients in their group. Patients will be considered to have relapsed if they fail at least one of their urine cotinine and carbon monoxide tests.
Smoking cessation rate at four months
Time frame: Up to 4 months
Smoking cessation rate will be measured as the ratio of the total number of patients who relapsed with total number of patients in their group. Patients will be considered to have relapsed if they fail at least one of their urine cotinine and carbon monoxide tests.
Smoking cessation rate at six months
Time frame: Up to 6 months
Smoking cessation rate will be measured as the ratio of the total number of patients who relapsed with total number of patients in their group. Patients will be considered to have relapsed if they fail at least one of their urine cotinine and carbon monoxide tests.
14 secondary outcomes
User engagement at an individual level
Time frame: Up to 6 months
Engagement at aggregated level - Mobile application rolling retention
Time frame: Up to 6 months
Engagement at aggregated level - Mobile application session length distribution
Time frame: Up to 6 months
Engagement at aggregated level - Mobile application session frequency
Time frame: Up to 6 months
Engagement at aggregated level - Mobile application sessions per user
Time frame: Up to 6 months
Engagement at aggregated level - Mobile application return rate
Time frame: Up to 6 months
User quitting attempts
Time frame: Up to 6 months
User app behavior
Time frame: Up to 6 months
User satisfaction with messages
Time frame: At 6 months after enrolment.
User message ratings
Time frame: Up to 6 months
User lifestyle feedback
Time frame: At enrollment and at 6 months after enrollment
User lifestyle feedback
Time frame: At enrollment and at 6 months after enrollment
User lifestyle feedback
Time frame: At enrollment and at 6 months after enrollment
Physical activity
Time frame: Up to 6 months
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 10 Apr 2019.
- Derived from this study: PubMed 30413176Hors-Fraile S, Malwade S, Spachos D, Fernandez-Luque L, Su CT, Jeng WL, Syed-Abdul S, Bamidis P, Li YJ. A recommender system to quit smoking with mobile motivational messages: study protocol for a randomized controlled trial. Trials. 2018 Nov 9;19(1):618. doi: 10.1186/s13063-018-3000-1.
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 Case in people with Explore Successful Method to Quit Smoking, run by Taipei Medical University at 1 site in Taiwan.
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 7 inclusion and 5 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 10 Apr 2019. 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 Taiwan. 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?
Smoking cessation rate at two months (time frame: Up to 2 months). The study lists 3 primary outcomes in all. 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 NCT03108651, 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 Apr 2019.