The Impact of a Smartphone App on the Quality of Pediatric Colonoscopy Preparations
10 października 2020 zaktualizowane przez: 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.
Przegląd badań
Status
Zakończony
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
42
Faza
- Nie dotyczy
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
5 lat do 18 lat (Dziecko, Dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
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 studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Potroić
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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.
|
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.
|
|
Aktywny komparator: 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.
|
Written Instruction
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Smartphone application use was associated with increased number of "excellent" colonoscopy preps.
Ramy czasowe: 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
|
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.
|
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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
The difference in the number of calls to the gastroenterology service between app users and controls.
Ramy czasowe: 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
|
Calls to the GI service were recorded by the GI staff.
|
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
|
|
The difference between app users and controls regarding patient arrival time.
Ramy czasowe: 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
|
Patient arrival time was taken from the patients arrival time in the endoscopy suite.
|
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
|
|
The significant difference between app users and controls regarding patient knowledge about the procedure.
Ramy czasowe: 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
|
A questionnaire with validated questions determined whether subjects improvement their knowledge before and after receiving colonoscopy information.
|
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
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Dyrektor Studium: Jeffrey Morganstern, MD, Stony Brook University Hospital
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
- 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.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
15 listopada 2014
Zakończenie podstawowe (Rzeczywisty)
1 maja 2015
Ukończenie studiów (Rzeczywisty)
1 maja 2015
Daty rejestracji na studia
Pierwszy przesłany
28 września 2020
Pierwszy przesłany, który spełnia kryteria kontroli jakości
10 października 2020
Pierwszy wysłany (Rzeczywisty)
19 października 2020
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
19 października 2020
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
10 października 2020
Ostatnia weryfikacja
1 października 2020
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
- 1132702
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
TAk
Opis planu IPD
I am happy to share all data in whatever way is easiest for everyone
Ramy czasowe udostępniania IPD
Immediately
Kryteria dostępu do udostępniania IPD
Email request
Typ informacji pomocniczych dotyczących udostępniania IPD
- Protokół badania
- Plan analizy statystycznej (SAP)
- Formularz świadomej zgody (ICF)
- Raport z badania klinicznego (CSR)
- Kod analityczny
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .