Clinical trial NCT03108651: Mobile Motivational Messages for Change (3M4Chan) Intervention in TMU
Official title: Mobile Motivational Messages for Change (3M4Chan) Intervention in TMU
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Explore Successful Method to Quit Smoking
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2017-04-11
Enrollment: 92
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention study with two parallel arms.
Primary purpose: SUPPORTIVE_CARE

Brief 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). 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* • 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

Primary outcomes:
measure: Smoking cessation rate at two months
timeFrame: Up to 2 months
measure: Smoking cessation rate at four months
timeFrame: Up to 4 months
measure: Smoking cessation rate at six months
timeFrame: Up to 6 months
Secondary outcomes:
measure: User engagement at an individual level
timeFrame: Up to 6 months
measure: Engagement at aggregated level - Mobile application rolling retention
timeFrame: Up to 6 months
measure: Engagement at aggregated level - Mobile application session length distribution
timeFrame: Up to 6 months
measure: Engagement at aggregated level - Mobile application session frequency
timeFrame: Up to 6 months
measure: Engagement at aggregated level - Mobile application sessions per user
timeFrame: Up to 6 months
measure: Engagement at aggregated level - Mobile application return rate
timeFrame: Up to 6 months
measure: User quitting attempts
timeFrame: Up to 6 months
measure: User app behavior
timeFrame: Up to 6 months
measure: User satisfaction with messages
timeFrame: At 6 months after enrolment.
measure: User message ratings
timeFrame: Up to 6 months
measure: User lifestyle feedback
timeFrame: At enrollment and at 6 months after enrollment
measure: User lifestyle feedback
timeFrame: At enrollment and at 6 months after enrollment
measure: User lifestyle feedback
timeFrame: At enrollment and at 6 months after enrollment
measure: Physical activity
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Syed Abdul Shabbir
Study officials:
References:
citation: 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.