The Impact of a Smartphone App on the Quality of Pediatric Colonoscopy Preparations
10 octobre 2020 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
42
Phase
- N'est pas applicable
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
5 ans à 18 ans (Enfant, Adulte)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Comparateur actif: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Smartphone application use was associated with increased number of "excellent" colonoscopy preps.
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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The difference in the number of calls to the gastroenterology service between app users and controls.
Délai: 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.
Délai: 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.
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Directeur d'études: Jeffrey Morganstern, MD, Stony Brook University Hospital
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
15 novembre 2014
Achèvement primaire (Réel)
1 mai 2015
Achèvement de l'étude (Réel)
1 mai 2015
Dates d'inscription aux études
Première soumission
28 septembre 2020
Première soumission répondant aux critères de contrôle qualité
10 octobre 2020
Première publication (Réel)
19 octobre 2020
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
19 octobre 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
10 octobre 2020
Dernière vérification
1 octobre 2020
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 1132702
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Oui
Description du régime IPD
I am happy to share all data in whatever way is easiest for everyone
Délai de partage IPD
Immediately
Critères d'accès au partage IPD
Email request
Type d'informations de prise en charge du partage d'IPD
- Protocole d'étude
- Plan d'analyse statistique (PAS)
- Formulaire de consentement éclairé (ICF)
- Rapport d'étude clinique (CSR)
- Code analytique
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .