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Trial Title:
A Mobile Application to Improve the Quality of Colonoscopy in Colorectal Cancer Screening Program (PrepColon APP)
NCT ID:
NCT06314022
Condition:
Colorectal Cancer
Premalignant Colon Lesions
Conditions: Official terms:
Colorectal Neoplasms
Precancerous Conditions
Conditions: Keywords:
quality colonoscopy
colorrectal cancer screening
mobile application
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
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
Masking:
Single (Investigator)
Masking description:
Patients who agree to participate in the study are randomized by a 1:1 block computer
program (an attempt will be made to balance the groups according to the type of laxative)
into two groups: group A: control group, which receives the standard information given in
writing, and group B: APP group, which receives the standard information together with
the mobile application individually adapted to the scheduled colonoscopy appointment and
the type of laxative.
Patients scheduled for a screening colonoscopy will be contacted by telephone, those who
agree to participate will be scheduled with the nurse, after giving their consent they
are randomized. Group B will indicate how to download the APP and its management. The
endoscopist performing the examination is blind for randomization and will assess colon
cleansing according to the Boston Bowel Scale (Lai EJ. et al Gastroinest Endosc 2009).
Intervention:
Intervention type:
Other
Intervention name:
Mobile application for colonoscopy preparation instructions
Description:
The APP will also consider the comorbidities and drugs of each patient. 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 the patient to
control the laxative intake instruction. The user must confirm the appointment 48 hours
in advance.
Arm group label:
APP group
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.
Criteria for 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
Gender:
All
Minimum age:
50 Years
Maximum age:
69 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Hospital Universitario Rio Hortega
Address:
City:
Valladolid
Zip:
47012
Country:
Spain
Start date:
May 2, 2024
Completion date:
December 30, 2025
Lead sponsor:
Agency:
Hospital del Rio Hortega
Agency class:
Other
Source:
Hospital del Rio Hortega
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06314022