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

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ClinicalTrials.gov Identifier: NCT03108651
Recruitment Status : Completed
First Posted : April 11, 2017
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
Shabbir Syed Abdul, Taipei Medical University

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.

Condition or disease Intervention/treatment Phase
Explore Successful Method to Quit Smoking Other: Case Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Intervention study with two parallel arms.
Masking: Single (Participant)
Masking Description: Researchers do not disclose about App and messages to control group
Primary Purpose: Supportive Care
Official Title: Mobile Motivational Messages for Change (3M4Chan) Intervention in TMU
Actual Study Start Date : September 1, 2017
Actual Primary Completion Date : March 2, 2019
Actual Study Completion Date : March 15, 2019

Arm Intervention/treatment
Active Comparator: Case
Motivational message will be administrated.
Other: Case
Motivational message will be administrated.

No Intervention: Control
Motivational message will not be administrated.



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. User engagement at an individual level [ Time Frame: Up to 6 months ]
    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.

  2. Engagement at aggregated level - Mobile application rolling retention [ Time Frame: Up to 6 months ]
    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.

  3. Engagement at aggregated level - Mobile application session length distribution [ Time Frame: Up to 6 months ]
    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.

  4. Engagement at aggregated level - Mobile application session frequency [ Time Frame: Up to 6 months ]
    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.

  5. Engagement at aggregated level - Mobile application sessions per user [ Time Frame: Up to 6 months ]
    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.

  6. Engagement at aggregated level - Mobile application return rate [ Time Frame: Up to 6 months ]
    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.

  7. User quitting attempts [ Time Frame: Up to 6 months ]
    Number of quitting attempts per patient, including the frequency of the quitting attempts.

  8. User app behavior [ Time Frame: Up to 6 months ]
    It will be measured as the time spent per app section.

  9. User satisfaction with messages [ Time Frame: At 6 months after enrolment. ]
    Patients' answers to a satisfaction questionnaire that will be handed to them at the end of the study.

  10. User message ratings [ Time Frame: Up to 6 months ]
    User's votes for each message in a 5 star scale.

  11. User lifestyle feedback [ Time Frame: At enrollment and at 6 months after enrollment ]
    Comparison of changes in user lifestyle (at baseline and after 6 months) through the combined questionnaire EQ-5D-5L.

  12. User lifestyle feedback [ Time Frame: At enrollment and at 6 months after enrollment ]
    Comparison of changes in user lifestyle (at baseline and after 6 months) through the combined questionnaire IPAQ for physical activity.

  13. User lifestyle feedback [ Time Frame: At enrollment and at 6 months after enrollment ]
    Comparison of changes in user lifestyle (at baseline and after 6 months) through the combined questionnaires SF-36.

  14. Physical activity [ Time Frame: Up to 6 months ]
    The physical activity would be measured as the total time (minutes) of activity per user, retrieved by GoogleFit in the app.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03108651


Locations
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Taiwan
Syed Abdul Shabbir
Taipei, Taiwan, 11031
Sponsors and Collaborators
Taipei Medical University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Shabbir Syed Abdul, Assistant Professor & Health IT Consultant, Taipei Medical University
ClinicalTrials.gov Identifier: NCT03108651    
Other Study ID Numbers: N201702069
First Posted: April 11, 2017    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No