- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03108651
Mobile Motivational Messages for Change (3M4Chan) Intervention in TMU
8 aprile 2019 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
92
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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-
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Taipei, Taiwan, 11031
- Syed Abdul Shabbir
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
20 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Comparatore attivo: Case
Motivational message will be administrated.
|
Motivational message will be administrated.
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Nessun intervento: Control
Motivational message will not be administrated.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Smoking cessation rate at two months
Lasso di tempo: 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.
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Up to 2 months
|
Smoking cessation rate at four months
Lasso di tempo: 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.
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Up to 4 months
|
Smoking cessation rate at six months
Lasso di tempo: 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.
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Up to 6 months
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
User engagement at an individual level
Lasso di tempo: 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.
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Up to 6 months
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Engagement at aggregated level - Mobile application rolling retention
Lasso di tempo: 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
Lasso di tempo: 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.
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Up to 6 months
|
Engagement at aggregated level - Mobile application session frequency
Lasso di tempo: 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.
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Up to 6 months
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Engagement at aggregated level - Mobile application sessions per user
Lasso di tempo: 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.
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Up to 6 months
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Engagement at aggregated level - Mobile application return rate
Lasso di tempo: Up to 6 months
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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.
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Up to 6 months
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User quitting attempts
Lasso di tempo: Up to 6 months
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Number of quitting attempts per patient, including the frequency of the quitting attempts.
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Up to 6 months
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User app behavior
Lasso di tempo: Up to 6 months
|
It will be measured as the time spent per app section.
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Up to 6 months
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User satisfaction with messages
Lasso di tempo: At 6 months after enrolment.
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Patients' answers to a satisfaction questionnaire that will be handed to them at the end of the study.
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At 6 months after enrolment.
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User message ratings
Lasso di tempo: Up to 6 months
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User's votes for each message in a 5 star scale.
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Up to 6 months
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User lifestyle feedback
Lasso di tempo: At enrollment and at 6 months after enrollment
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Comparison of changes in user lifestyle (at baseline and after 6 months) through the combined questionnaire EQ-5D-5L.
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At enrollment and at 6 months after enrollment
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User lifestyle feedback
Lasso di tempo: 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.
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At enrollment and at 6 months after enrollment
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User lifestyle feedback
Lasso di tempo: At enrollment and at 6 months after enrollment
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Comparison of changes in user lifestyle (at baseline and after 6 months) through the combined questionnaires SF-36.
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At enrollment and at 6 months after enrollment
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Physical activity
Lasso di tempo: Up to 6 months
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The physical activity would be measured as the total time (minutes) of activity per user, retrieved by GoogleFit in the app.
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Up to 6 months
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 settembre 2017
Completamento primario (Effettivo)
2 marzo 2019
Completamento dello studio (Effettivo)
15 marzo 2019
Date di iscrizione allo studio
Primo inviato
24 marzo 2017
Primo inviato che soddisfa i criteri di controllo qualità
5 aprile 2017
Primo Inserito (Effettivo)
11 aprile 2017
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
10 aprile 2019
Ultimo aggiornamento inviato che soddisfa i criteri QC
8 aprile 2019
Ultimo verificato
1 aprile 2019
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- N201702069
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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