Clinical trial NCT06314022: A Mobile Application to Improve the Quality of Colonoscopy in Colorectal Cancer Screening Program (PrepColon APP)
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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Colorectal Cancer
Premalignant Colon Lesions
Keywords: quality colonoscopy
colorrectal cancer screening
mobile application
Lead sponsor: Hospital del Rio Hortega
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 470
Sex: ALL
Minimum age (years): 50
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Each subject 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: they will be given the instructions in writing and will also be indicated how to install the APP.
Primary purpose: SUPPORTIVE_CARE

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 66.7%. 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 and/or 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.

Eligibility criteria: Inclusion Criteria:

* -Subjects between 50-69 years old from the CRC screening program with FIT (\>100ng/ml).
* Informed consent granted in writing

Exclusion Criteria:

* Refusal to give informed consent.
* Those who do not have a smartphone with a minimum version of the operating system (Android 4.4 or iOS 14, which cover more than 99% of the terminals in use)
* Symptomatic patients
* Subjects at elevated risk of CRC due to family history or inherited polyposis diseases or inflammatory bowel disease

Primary outcomes:
measure: Compliance with the diet and intake of laxatives with the use of a mobile application
timeFrame: at the moment of the procedure
measure: Evaluate the quality of colon cleansing with mobile application as an experimental factor
timeFrame: at the moment of the procedure
measure: Assessment of the usability of the APP
timeFrame: at the moment of the procedure
measure: Compliance with the laxative intake with the use of the mobile application
timeFrame: At the moment of the procedure
Secondary outcomes:
measure: Assessment of the difficulty of the preparation instructions
timeFrame: at the moment of the procedure
measure: Evaluate colonoscopy quality indicators:
timeFrame: at the moment of the procedure and after one month with the histological results
measure: Evaluate attendance at the scheduled colonoscopy appointment
timeFrame: at the moment of the colonoscopy
measure: Evaluate colonoscopy quality indicators
timeFrame: at the moment of the colonoscopy
Other outcomes:
Locations:
city: Valladolid
country: Spain
facility: Hospital Universitario Rio Hortega
Study officials:
affiliation: Hospital Universitario Rio Hortega
name: Henar Nuñez Rodriguez, MDPhD
role: PRINCIPAL_INVESTIGATOR
References: