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

8. april 2019 oppdatert av: Shabbir Syed Abdul, Taipei Medical University
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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

92

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Taiwan
      • Taipei, Taiwan, 11031
        • Syed Abdul Shabbir

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

20 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Case
Motivational message will be administrated.
Annen: Case
Motivational message will be administrated.
Ingen inngripen: Control
Motivational message will not be administrated.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Smoking cessation rate at two months
Tidsramme: 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.
Up to 2 months
Smoking cessation rate at four months
Tidsramme: 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.
Up to 4 months
Smoking cessation rate at six months
Tidsramme: 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.
Up to 6 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
User engagement at an individual level
Tidsramme: 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.
Up to 6 months
Engagement at aggregated level - Mobile application rolling retention
Tidsramme: 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.
Up to 6 months
Engagement at aggregated level - Mobile application session length distribution
Tidsramme: 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.
Up to 6 months
Engagement at aggregated level - Mobile application session frequency
Tidsramme: 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.
Up to 6 months
Engagement at aggregated level - Mobile application sessions per user
Tidsramme: 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.
Up to 6 months
Engagement at aggregated level - Mobile application return rate
Tidsramme: 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.
Up to 6 months
User quitting attempts
Tidsramme: Up to 6 months
Number of quitting attempts per patient, including the frequency of the quitting attempts.
Up to 6 months
User app behavior
Tidsramme: Up to 6 months
It will be measured as the time spent per app section.
Up to 6 months
User satisfaction with messages
Tidsramme: At 6 months after enrolment.
Patients' answers to a satisfaction questionnaire that will be handed to them at the end of the study.
At 6 months after enrolment.
User message ratings
Tidsramme: Up to 6 months
User's votes for each message in a 5 star scale.
Up to 6 months
User lifestyle feedback
Tidsramme: 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.
At enrollment and at 6 months after enrollment
User lifestyle feedback
Tidsramme: 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.
At enrollment and at 6 months after enrollment
User lifestyle feedback
Tidsramme: 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.
At enrollment and at 6 months after enrollment
Physical activity
Tidsramme: 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.
Up to 6 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Taipei Medical University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. september 2017

Primær fullføring (Faktiske)

2. mars 2019

Studiet fullført (Faktiske)

15. mars 2019

Datoer for studieregistrering

Først innsendt

24. mars 2017

Først innsendt som oppfylte QC-kriteriene

5. april 2017

Først lagt ut (Faktiske)

11. april 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. april 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. april 2019

Sist bekreftet

1. april 2019

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • N201702069

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Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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