- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT03108651
Mobile Motivational Messages for Change (3M4Chan) Intervention in TMU
8 april 2019 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
92
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
-
Taipei, Taiwan, 11031
- Syed Abdul Shabbir
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
20 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Actieve vergelijker: Case
Motivational message will be administrated.
|
Motivational message will be administrated.
|
Geen tussenkomst: Control
Motivational message will not be administrated.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Smoking cessation rate at two months
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
User engagement at an individual level
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Up to 6 months
|
Number of quitting attempts per patient, including the frequency of the quitting attempts.
|
Up to 6 months
|
User app behavior
Tijdsspanne: Up to 6 months
|
It will be measured as the time spent per app section.
|
Up to 6 months
|
User satisfaction with messages
Tijdsspanne: 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
Tijdsspanne: Up to 6 months
|
User's votes for each message in a 5 star scale.
|
Up to 6 months
|
User lifestyle feedback
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 september 2017
Primaire voltooiing (Werkelijk)
2 maart 2019
Studie voltooiing (Werkelijk)
15 maart 2019
Studieregistratiedata
Eerst ingediend
24 maart 2017
Eerst ingediend dat voldeed aan de QC-criteria
5 april 2017
Eerst geplaatst (Werkelijk)
11 april 2017
Updates van studierecords
Laatste update geplaatst (Werkelijk)
10 april 2019
Laatste update ingediend die voldeed aan QC-criteria
8 april 2019
Laatst geverifieerd
1 april 2019
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- N201702069
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Case
-
University of PittsburghVoltooidStenose van de halsslagaderVerenigde Staten
-
Treatment Research InstituteNational Institute on Drug Abuse (NIDA)VoltooidDwang om deel te nemen aan onderzoekVerenigde Staten
-
Soterix MedicalVoltooid
-
Sichuan Provincial People's HospitalWervingStenose van de halsslagaderChina
-
University of OxfordNHS Health Technology Assessment Programme; BUPA FoundationOnbekendStenose van de halsslagaderDuitsland, Italië, Israël, Verenigd Koninkrijk, Kroatië, Zwitserland, China, Canada, Oostenrijk, Zweden, Spanje, België, Tsjechië, Frankrijk, Verenigde Staten, Brazilië, Bulgarije, Egypte, Estland, Griekenland, Hongarije, Ierland, Japan en meer
-
Xuanwu Hospital, BeijingWervingHalsslagader plaque | Stenting van de halsslagader | Carotis-endarteriëctomieChina
-
Environmental Protection Agency (EPA)VoltooidAdemhalingsdepressieVerenigde Staten
-
Duke UniversityCAS Medical Systems, Inc.BeëindigdHartkatheterisatieVerenigde Staten
-
Thomas G. Brott, M.D.National Institute of Neurological Disorders and Stroke (NINDS)WervingStenose van de halsslagaderVerenigde Staten, Canada, Israël, Spanje, Australië