Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06314022
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-18
First Post:
2024-03-05
Brief Title:
A Mobile Application to Improve the Quality of Colonoscopy in Colorectal Cancer Screening Program PrepColon APP
Sponsor:
Hospital del Río Hortega
Organization:
Hospital del Río Hortega
Study Overview
Official Title:
Design of a Mobile Application to Improve the Quality of Colonoscopy and Its Implementation in Colorectal Cancer Screening Program a Randomized Multicenter Study PrepColon APP Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PREPCOLON
Brief Summary:
Colonoscopy is the gold standard for the diagnosis and resection of preneoplastic lesions allowing the prevention of colon cancer A colonoscopy is more efficient with proper preparation of the colon as it allows for a higher rate of adenoma detection and cecal intubation In routine practice up to 30 of colonoscopies are poorly prepared and 11 of patients do not show up for their appointment Adenomas not visualized in the initial colonoscopy due to poor preparation reached 68 and the rate of undetected cancers was 667 A proper colon cleanse is conditioned by different factors among them failure to comply with the diet and take laxatives poses 5 times the risk of having a deficient colon preparation The purpose of our study is the design and implementation of an app that facilitates the preparation of colonoscopy and evaluates its impact on compliance with diet and laxative intake
Detailed Description:
STUDY DESIGN AND METHODS
Study Design
Phase 1 Design of the mobile application APP The APP will be designed in a participatory manner by the research team of the project formed by doctors nurses statisticians and telecommunications engineers The application should be usable with both Android and iOS devices so we will use the Flutter framework to build apps for different platforms with a single code base
When arranging a colonoscopy the patient will install the APP on their mobile phone and indicate the date and time of the test The APP will be responsible for supporting the preparation of the colon cleansing for which in addition to being able to visualize the corresponding information it will make use of notifications to show diet reminders and laxative intakes
More specifically these could be some notifications
3 days before the appointment - Notification of start of preparation with a low fibre diet
24 hours before the appointment - Notification of laxative intake
The APP will also consider the comorbidities and drugs of each participant It can be adapted to the different types of laxative 4 2 or 1 litre and notify the need to discontinue anticoagulant andor antiplatelet treatments by contacting with the primary care physician Additionally the application may ask short questions to control the laxative intake instruction The user must confirm the appointment 48 hours in advance The design of the APP aims to be intuitive and easy to use by the target population 50-69 years allowing to adapt the font size and zoom in on the images to facilitate the visualization of the information
The APP will be multilingual for English and Spanish and others may be incorporated if deemed necessary An agile and iterative methodology of software development will be followed as SCRUM in the realization of the APP Thus sprints of about 3 weeks will be planned with delivery of functional software that will progressively incorporate the different functionalities planned for the APP
Phase 2 Re-evaluation of the APP after the inclusion of 30 patients the APP will be re-evaluated through a usability questionnaire and adjustments and changes will be made if necessary
Phase 3 Prospective multicentre and randomized study in asymptomatic patients between 50 and 69 years who attend screening colonoscopy after a positive FIT 100 ng ml
The study will be carried out in the Digestive Service of 3 hospitals in Castilla y León Virgen de la Concha Hospital in Zamora Medina del Campo Hospital and Río Hortega University Hospital in Valladolid Participants will be randomized into two groups according to the instructions given to perform the preparation of the colon prior to colonoscopy group A perform the preparation with the written instructions delivered in the consultation and group B the investigators will give the instructions in writing and will also indicate how to install the APP to the participants
Study Design
Phase 1 Design of the mobile application APP The APP will be designed in a participatory manner by the research team of the project formed by doctors nurses statisticians and telecommunications engineers The application should be usable with both Android and iOS devices so we will use the Flutter framework to build apps for different platforms with a single code base
When arranging a colonoscopy the patient will install the APP on their mobile phone and indicate the date and time of the test The APP will be responsible for supporting the preparation of the colon cleansing for which in addition to being able to visualize the corresponding information it will make use of notifications to show diet reminders and laxative intakes
More specifically these could be some notifications
3 days before the appointment - Notification of start of preparation with a low fibre diet
24 hours before the appointment - Notification of laxative intake
The APP will also consider the comorbidities and drugs of each participant It can be adapted to the different types of laxative 4 2 or 1 litre and notify the need to discontinue anticoagulant andor antiplatelet treatments by contacting with the primary care physician Additionally the application may ask short questions to control the laxative intake instruction The user must confirm the appointment 48 hours in advance The design of the APP aims to be intuitive and easy to use by the target population 50-69 years allowing to adapt the font size and zoom in on the images to facilitate the visualization of the information
The APP will be multilingual for English and Spanish and others may be incorporated if deemed necessary An agile and iterative methodology of software development will be followed as SCRUM in the realization of the APP Thus sprints of about 3 weeks will be planned with delivery of functional software that will progressively incorporate the different functionalities planned for the APP
Phase 2 Re-evaluation of the APP after the inclusion of 30 patients the APP will be re-evaluated through a usability questionnaire and adjustments and changes will be made if necessary
Phase 3 Prospective multicentre and randomized study in asymptomatic patients between 50 and 69 years who attend screening colonoscopy after a positive FIT 100 ng ml
The study will be carried out in the Digestive Service of 3 hospitals in Castilla y León Virgen de la Concha Hospital in Zamora Medina del Campo Hospital and Río Hortega University Hospital in Valladolid Participants will be randomized into two groups according to the instructions given to perform the preparation of the colon prior to colonoscopy group A perform the preparation with the written instructions delivered in the consultation and group B the investigators will give the instructions in writing and will also indicate how to install the APP to the participants
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None