Mobile Motivational Messages for Change (3M4Chan) Intervention in TMU

NCT03108651 | Completed

• 1 other identifier: N201702069
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Explore Successful Method to Quit Smoking

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Up to 6 months

Secondary Outcomes (14)

• User engagement at an individual level

  Up to 6 months

• Engagement at aggregated level - Mobile application rolling retention

  Up to 6 months

• Engagement at aggregated level - Mobile application session length distribution

  Up to 6 months

• Engagement at aggregated level - Mobile application session frequency

  Up to 6 months

• Engagement at aggregated level - Mobile application sessions per user

  Up to 6 months

Study Arms (2)

Case

ACTIVE COMPARATOR

Motivational message will be administrated.

Other: Case

Control

NO INTERVENTION

Motivational message will not be administrated.

Interventions

Case OTHER

Motivational message will be administrated.

Case

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (1)

Syed Abdul Shabbir

Taipei, 11031, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 30413176 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Researchers do not disclose about App and messages to control group
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor & Health IT Consultant

Model Details: Intervention study with two parallel arms.

Study Record Dates

• First Submitted: March 24, 2017
• First Posted: April 11, 2017
• Study Start: September 1, 2017
• Primary Completion: March 2, 2019
• Study Completion: March 15, 2019
• Last Updated: April 10, 2019

Record last verified: 2019-04

Locations

TW (1)