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- Ensaio Clínico NCT04979559
Mobile Health Application of Screening and Early Intervention for Prediabetic Patient at Primary Health Cares Setting
Development Mobile Health Application of Screening and Early Intervention for Prediabetic Patient at Primary Health Cares Setting: Protocol of a Pilot Study
Background: Preventing type-2 diabetes mellitus begins with early screening and intervention of prediabetic participants. Until now, prediabetes screening and early intervention have not been optimal. The rapid advancement of technology, as well as its increased use, may provide an opportunity to improve the quality and cost of healthcare services. It is quite practicable to investigate and implement a valid, practical and easy-to-use mobile health application for participants and health staffs in screening and early intervention of prediabetes participants at primary health cares setting. This protocol aimed to identify and develop a valid, practical, and easy-to-use mobile health application for screening and early intervention of prediabetes participants at primary health cares.
Methods: This protocol was prepared in accordance with the Standard Protocol Items: Recommendations for Interventional Trials 2013 statement. This is a mixed-methods study with sequential exploratory approach. This project will begin with in-depth interview to gather qualitative information regarding mobile health application necessity for prediabetes participants at the primary health cares. The impact of the usage will be studied quantitatively using randomized controlled trial. Prediabetic participants and primary health cares staffs at Yogyakarta province will be the research subjects. The collected findings will be examined based on the type of the data.
Discussion: The proposed research aimed to obtain information and trial results regarding mobile health application usage for prediabetes participants screening and early intervention at primary health cares setting.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
The goal of this study is to create a mobile health application for prediabetes patients that included screening and early intervention in Primary Health Cares (PHCs) setting. More specifically, the objectives are as follows:
- To portray regular prediabetes screening and early intervention practice in PHCs.
- To assess prediabetes screening and early intervention data necessity for mobile health application model at PHCs.
- To assess the feasibility of mobile health application usage for screening and early intervention of prediabetes patients at PHCs.
- To assess internal and external factors that influence the intention-to-use, easiness, and usefulness of mobile health applications for prediabetes patients and health staff.
- To assess the impact of early intervention using mobile health applications on prediabetes patients.
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Yaltafit A Jeem
- Número de telefone: +62 856-4366-1294
- E-mail: yaltafit.abror.j@ugm.ac.id
Estude backup de contato
- Nome: Russy N Andriani
- Número de telefone: +6287821562151
- E-mail: russy.novita@gmail.com
Locais de estudo
-
-
Yogyakarta
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Sleman, Yogyakarta, Indonésia, 55571
- Recrutamento
- Kalasan PHC
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Contato:
- Yaltafit A Jeem
- Número de telefone: +62 856-4366-1294
- E-mail: yaltafit.abror.j@ugm.ac.id
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- diagnosed as the prediabetic state using American Diabetes Association (ADA) criteria
- have no previous diagnosis of type 2 diabetes or history of taking anti-hyperglycemic drugs
- have access to and able to use a personal smartphone
- willing to undertake study activities and written informed consent
Exclusion Criteria:
- severe medical condition
- disability to perform physical activity
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Triagem
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: mHealth apps
The participants in this arm will receive information regarding mobile health applications used for screening and early intervention of the prediabetic states.
|
Mobile health application intervention including screening and early intervention such as diet and physical activity suggestion
|
Comparador Ativo: Standard care
The participant in this arm will receive regular practice or standard care of screening and early intervention of prediabetic state.
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Regular practice for screening and early intervention for prediabetes patient in primary health cares setting
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Body weight mean change from baseline
Prazo: at baseline and after intervention at 12-weeks
|
Participants' body weight measured by scales using kilograms (kg) measurement unit
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at baseline and after intervention at 12-weeks
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Waist circumference mean change from baseline
Prazo: at baseline and after intervention at 12-weeks
|
Participants' waist circumference measured using measuring tape in centimeter (cm) measurement unit
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at baseline and after intervention at 12-weeks
|
Fasting blood glucose mean change from baseline
Prazo: at baseline and after intervention at 12-weeks
|
Participants' fasting blood glucose measured from vein blood in milligram per deciliter (mg/dL) measurement unit
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at baseline and after intervention at 12-weeks
|
Hemoglobin A1c mean change from baseline
Prazo: at baseline and after intervention at 12-weeks
|
Participants' Hemoglobin A1c measured from vein blood in percent
|
at baseline and after intervention at 12-weeks
|
Oral glucose tolerance test mean change from baseline
Prazo: at baseline and after intervention at 12-weeks
|
Participants' oral glucose tolerance test measured from vein blood in milligram per deciliter (mg/dL) measurement unit
|
at baseline and after intervention at 12-weeks
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Area under the curve of screening instrument compared to American Diabetes Association criteria
Prazo: immediately after the intervention begin
|
screening accuracy of the instrument reported using graph
|
immediately after the intervention begin
|
Sensitivity value of screening instrument compared to American Diabetes Association criteria
Prazo: immediately after the intervention begin
|
Sensitivity value of the instrument calculated using formula derived from 2x2 tables of diagnostic test
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immediately after the intervention begin
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Specificity value of screening instrument compared to American Diabetes Association criteria
Prazo: immediately after the intervention begin
|
Specificity value of the instrument calculated using formula derived from 2x2 tables of diagnostic test
|
immediately after the intervention begin
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Positive predictive value of screening instrument compared to American Diabetes Association criteria
Prazo: immediately after the intervention begin
|
Positive predictive value of the instrument calculated using formula derived from 2x2 tables of diagnostic test
|
immediately after the intervention begin
|
Negative predictive value of screening instrument compared to American Diabetes Association criteria
Prazo: immediately after the intervention begin
|
Negative predictive value of the instrument calculated using formula derived from 2x2 tables of diagnostic test
|
immediately after the intervention begin
|
Accuracy value of screening instrument compared to American Diabetes Association criteria
Prazo: immediately after the intervention begin
|
Accuracy predictive value of the instrument calculated using formula derived from 2x2 tables of diagnostic test
|
immediately after the intervention begin
|
Likelihood ratio of screening instrument compared to American Diabetes Association criteria
Prazo: immediately after the intervention begin
|
Likelihood ratio of the instrument calculated using formula derived from 2x2 tables of diagnostic test
|
immediately after the intervention begin
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Participant's acceptance of mobile health application
Prazo: after intervention at 12-weeks
|
evaluation of participant's acceptance to the device using Mobile Health Application Acceptance Questioner adapted from previous study
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after intervention at 12-weeks
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Yaltafit A Jeem, Gadjah Mada University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- KE/FK/1375/EC/2020
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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