The Impact of a Smartphone App on the Quality of Pediatric Colonoscopy Preparations
10 de outubro de 2020 atualizado por: James Brief, Stony Brook University
The investigators developed a smartphone app that guides pediatric patients and their families through colonoscopy prep in an attempt to see if an app could improve the colonoscopy process.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
The investigators created a smartphone app designed for pediatric patients and their families that informs patients about their colonoscopy procedure, alerts them when to take their medications throughout the hours-long colonoscopy prep process and tells them when to arrive to the endoscopy suite.
The investigators designed a study to determine if this app will yield improved colonoscopy cleanouts, better patient understanding of the procedure, fewer calls to the GI service and more punctual arrival times to the endoscopy suite compared to patients who receive written instructions that do not actively interact with the patient before, during or after their colonoscopy prep.
Tipo de estudo
Intervencional
Inscrição (Real)
42
Estágio
- Não aplicável
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
5 anos a 18 anos (Filho, Adulto)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Aged 5-18 years scheduled to undergo a diagnostic and/or therapeutic colonoscopy
Exclusion Criteria:
- Patients who had undergone a colonoscopy within the past one year
- Patients admitted for a nasogastric (NG) cleanout
- Patients requiring colonoscopy preparation medication other than Polyethylene Glycol
- Patients with poor understanding of English.
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: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: App Subject
Users who were assigned to use a smartphone app downloaded a free app from the iOS App or Google Play stores titled "SB Colonoscopy Prep."
The app informed subjects about their colonoscopy procedure, alerts them when to take their medications throughout the hours-long colonoscopy prep process and tells them when to arrive to the endoscopy suite.
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We created a smartphone app that informs patients about their colonoscopy procedure, alerts them when to take their medications throughout the hours-long colonoscopy prep process and tells them when to arrive to the endoscopy suite.
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Comparador Ativo: Written Instruction Subjects
Subjects in the control group were given a three-page document that described the procedure and instructed users on how to take the preparation medications.
The written instructions had a list of frequently asked questions about colonoscopies and the URL of a website where users could view the animated video that was included in the app.
The written instructions also contained the time and date of the procedure.
All subjects were instructed to arrive one hour before their scheduled procedure.
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Written Instruction
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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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Smartphone application use was associated with increased number of "excellent" colonoscopy preps.
Prazo: Each subject was assessed from the time they were scheduled for their colonoscopy to the day of their procedure, up to three months for subjects. Subjects were scored on their colonoscopies immediately following the procedure once the patient was stable
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Prep quality was measured with the validated Boston Scoring Scale.
A score of 0, 1, 2 or 3 is given to the right, transverse and left colon based on the amount and consistency of stool visualized as well as the ease or difficulty of guiding endoscopic instrumentation during a colonoscopy.
Higher scores indicate a cleaner colon and as per Lai, a Boston Score of 7 or above indicates an "excellent" prep.
To eliminate bias, the four grading gastroenterologists did not know whether subjects had used written or app instructions.
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Each subject was assessed from the time they were scheduled for their colonoscopy to the day of their procedure, up to three months for subjects. Subjects were scored on their colonoscopies immediately following the procedure once the patient was stable
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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The difference in the number of calls to the gastroenterology service between app users and controls.
Prazo: Each subject was assessed from the time they were scheduled for their colonoscopy to the day of their procedure, up to three months for subjects
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Calls to the GI service were recorded by the GI staff.
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Each subject was assessed from the time they were scheduled for their colonoscopy to the day of their procedure, up to three months for subjects
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The difference between app users and controls regarding patient arrival time.
Prazo: Each subject was assessed from the time they were scheduled for their colonoscopy to the day of their procedure, up to three months for subjects
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Patient arrival time was taken from the patients arrival time in the endoscopy suite.
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Each subject was assessed from the time they were scheduled for their colonoscopy to the day of their procedure, up to three months for subjects
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The significant difference between app users and controls regarding patient knowledge about the procedure.
Prazo: Each subject was assessed from the time they were scheduled for their colonoscopy to the day of their procedure, up to three months for subjects
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A questionnaire with validated questions determined whether subjects improvement their knowledge before and after receiving colonoscopy information.
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Each subject was assessed from the time they were scheduled for their colonoscopy to the day of their procedure, up to three months for subjects
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: Jeffrey Morganstern, MD, Stony Brook University Hospital
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Ting TV, Kudalkar D, Nelson S, Cortina S, Pendl J, Budhani S, Neville J, Taylor J, Huggins J, Drotar D, Brunner HI. Usefulness of cellular text messaging for improving adherence among adolescents and young adults with systemic lupus erythematosus. J Rheumatol. 2012 Jan;39(1):174-9. doi: 10.3899/jrheum.110771. Epub 2011 Nov 15.
- Kang X, Zhao L, Leung F, Luo H, Wang L, Wu J, Guo X, Wang X, Zhang L, Hui N, Tao Q, Jia H, Liu Z, Chen Z, Liu J, Wu K, Fan D, Pan Y, Guo X. Delivery of Instructions via Mobile Social Media App Increases Quality of Bowel Preparation. Clin Gastroenterol Hepatol. 2016 Mar;14(3):429-435.e3. doi: 10.1016/j.cgh.2015.09.038. Epub 2015 Oct 20.
- Pall H, Zacur GM, Kramer RE, Lirio RA, Manfredi M, Shah M, Stephen TC, Tucker N, Gibbons TE, Sahn B, McOmber M, Friedlander J, Quiros JA, Fishman DS, Mamula P. Bowel preparation for pediatric colonoscopy: report of the NASPGHAN endoscopy and procedures committee. J Pediatr Gastroenterol Nutr. 2014 Sep;59(3):409-16. doi: 10.1097/MPG.0000000000000447.
- Pillai A, Menon R, Oustecky D, Ahmad A. Educational Colonoscopy Video Enhances Bowel Preparation Quality and Comprehension in an Inner City Population. J Clin Gastroenterol. 2018 Jul;52(6):515-518. doi: 10.1097/MCG.0000000000000893.
- Hayat U, Lee PJ, Lopez R, Vargo JJ, Rizk MK. Online Educational Video Improves Bowel Preparation and Reduces the Need for Repeat Colonoscopy Within Three Years. Am J Med. 2016 Nov;129(11):1219.e1-1219.e9. doi: 10.1016/j.amjmed.2016.06.011. Epub 2016 Jul 6.
- Park JS, Kim MS, Kim H, Kim SI, Shin CH, Lee HJ, Lee WS, Moon S. A randomized controlled trial of an educational video to improve quality of bowel preparation for colonoscopy. BMC Gastroenterol. 2016 Jun 17;16(1):64. doi: 10.1186/s12876-016-0476-6.
- Lorenzo-Zuniga V, Moreno de Vega V, Marin I, Barbera M, Boix J. Improving the quality of colonoscopy bowel preparation using a smart phone application: a randomized trial. Dig Endosc. 2015 Jul;27(5):590-5. doi: 10.1111/den.12467. Epub 2015 Mar 20.
- Cook KA, Modena BD, Simon RA. Improvement in Asthma Control Using a Minimally Burdensome and Proactive Smartphone Application. J Allergy Clin Immunol Pract. 2016 Jul-Aug;4(4):730-737.e1. doi: 10.1016/j.jaip.2016.03.005. Epub 2016 Apr 20.
- Iacoviello BM, Steinerman JR, Klein DB, Silver TL, Berger AG, Luo SX, Schork NJ. Clickotine, A Personalized Smartphone App for Smoking Cessation: Initial Evaluation. JMIR Mhealth Uhealth. 2017 Apr 25;5(4):e56. doi: 10.2196/mhealth.7226.
- Voiosu A, Tantau A, Garbulet C, Tantau M, Mateescu B, Baicus C, Voiosu R, Voiosu T. Factors affecting colonoscopy comfort and compliance: a questionnaire based multicenter study. Rom J Intern Med. 2014;52(3):151-7.
- Sagawa T, Sato K, Tomizawa T, Mizuide M, Yasuoka H, Shimoyama Y, Kuribayashi S, Kakizaki S, Kawamura O, Kusano M, Yamada M. A prospective randomized controlled trial of AJG522 versus standard PEG+E as bowel preparation for colonoscopy. Biomed Res Int. 2015;2015:521756. doi: 10.1155/2015/521756. Epub 2015 Jan 22.
- Perski O, Blandford A, Ubhi HK, West R, Michie S. Smokers' and drinkers' choice of smartphone applications and expectations of engagement: a think aloud and interview study. BMC Med Inform Decis Mak. 2017 Feb 28;17(1):25. doi: 10.1186/s12911-017-0422-8.
- Badawy SM, Kuhns LM. Economic Evaluation of Text-Messaging and Smartphone-Based Interventions to Improve Medication Adherence in Adolescents with Chronic Health Conditions: A Systematic Review. JMIR Mhealth Uhealth. 2016 Oct 25;4(4):e121. doi: 10.2196/mhealth.6425.
- Iribarren SJ, Cato K, Falzon L, Stone PW. What is the economic evidence for mHealth? A systematic review of economic evaluations of mHealth solutions. PLoS One. 2017 Feb 2;12(2):e0170581. doi: 10.1371/journal.pone.0170581. eCollection 2017.
- Brief J, Chawla A, Lerner D, Vitola B, Woroniecki R, Morganstern J. The Impact of a Smartphone App on the Quality of Pediatric Colonoscopy Preparations: Randomized Controlled Trial. JMIR Pediatr Parent. 2020 Nov 10;3(2):e18174. doi: 10.2196/18174.
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)
15 de novembro de 2014
Conclusão Primária (Real)
1 de maio de 2015
Conclusão do estudo (Real)
1 de maio de 2015
Datas de inscrição no estudo
Enviado pela primeira vez
28 de setembro de 2020
Enviado pela primeira vez que atendeu aos critérios de CQ
10 de outubro de 2020
Primeira postagem (Real)
19 de outubro de 2020
Atualizações de registro de estudo
Última Atualização Postada (Real)
19 de outubro de 2020
Última atualização enviada que atendeu aos critérios de controle de qualidade
10 de outubro de 2020
Última verificação
1 de outubro de 2020
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- 1132702
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Sim
Descrição do plano IPD
I am happy to share all data in whatever way is easiest for everyone
Prazo de Compartilhamento de IPD
Immediately
Critérios de acesso de compartilhamento IPD
Email request
Tipo de informação de suporte de compartilhamento de IPD
- Protocolo de estudo
- Plano de Análise Estatística (SAP)
- Termo de Consentimento Livre e Esclarecido (TCLE)
- Relatório de Estudo Clínico (CSR)
- Código Analítico
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Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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