Mobile Motivational Messages for Change (3M4Chan) Intervention in TMU
8 de abril de 2019 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
92
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Taipei, Taiwan, 11031
- Syed Abdul Shabbir
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
20 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Comparador Ativo: Case
Motivational message will be administrated.
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Motivational message will be administrated.
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Sem intervenção: Control
Motivational message will not be administrated.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Smoking cessation rate at two months
Prazo: Up to 2 months
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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
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Smoking cessation rate at four months
Prazo: Up to 4 months
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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
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Smoking cessation rate at six months
Prazo: Up to 6 months
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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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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User engagement at an individual level
Prazo: Up to 6 months
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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
Prazo: Up to 6 months
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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.
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Up to 6 months
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Engagement at aggregated level - Mobile application session length distribution
Prazo: Up to 6 months
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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
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Engagement at aggregated level - Mobile application session frequency
Prazo: Up to 6 months
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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
Prazo: Up to 6 months
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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
Prazo: 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
Prazo: 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
Prazo: Up to 6 months
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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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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 IPAQ for physical activity.
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At enrollment and at 6 months after enrollment
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User lifestyle feedback
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
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Patrocinador
Publicações e links úteis
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de setembro de 2017
Conclusão Primária (Real)
2 de março de 2019
Conclusão do estudo (Real)
15 de março de 2019
Datas de inscrição no estudo
Enviado pela primeira vez
24 de março de 2017
Enviado pela primeira vez que atendeu aos critérios de CQ
5 de abril de 2017
Primeira postagem (Real)
11 de abril de 2017
Atualizações de registro de estudo
Última Atualização Postada (Real)
10 de abril de 2019
Última atualização enviada que atendeu aos critérios de controle de qualidade
8 de abril de 2019
Última verificação
1 de abril de 2019
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- N201702069
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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