Clinical trial NCT06916052: Study to Analyse the Use of a Digital Platform for the Preparation and Follow-up of Patients With Scheduled Outpatients Colonoscopy
Official title: An Observational Study of the Digital Platform Use for the Preparation and Monitoring of Patients With Scheduled Outpatient Colonoscopy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Outpatient Colonoscopy
Keywords: Colonoscopy preparation
Digital Platform
Caaring
Outpatient colonoscopy
DTx
Patient-reported Data
Real World Data
RWD
PROMs
Digital Health
Lead sponsor: Persei Vivarium
Sponsor class: OTHER
Collaborators: name: Effice Servicios Para la Investigacion S.L.
First posted: 2025-04-08
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients from the Hospital Clínic in Barcelona diagnosed with a scheduled colonoscopy who meet the selection criteria and sign the informed consent will be included.

Brief summary: The goal of this clinical trial investigation with device is to to analyze the use of the Caaring® digital platform for the preparation and follow-up of scheduled colonoscopy.

Colonoscopy is a difficult procedure, and it is estimated that bowel preparation is inadequate in about 25% of patients. The main question it aims to answer is if the use of a digital platform (Caaring®) could be an effective tool for reducing the percentage of inadequate bowel preparations in patients with a scheduled colonoscopy. To this end, the application will provide precise instructions to patients.

A prospective, single-center, observational study with software device: The recruitment phase is expected to last two months. Patients will be followed for one month after the colonoscopy and 14 days prior to it.

Additionally, measuring patient experience and monitoring adverse effects after a colonoscopy are crucial to improving the safety of colonoscopies and the quality of healthcare, promoting higher quality colonoscopy services.

For that to happen, participants must have sufficient technological skills to use a smartphone.

Detailed description: A prospective, single-center, observational study with software device. The protocol and informed consent documents have been reviewed and approved by the hospital human subjects reviewboard and the study will be performed in accordance with the Declaration of Helsinki.

Eligibility criteria: Inclusion Criteria:

* Age 18 or older.
* Signed informed consent.
* Patients scheduled for outpatient colonoscopy.
* Patients able to complete the study questionnaires.
* Patients who regularly use a smartphone

Exclusion Criteria:

* Patients enrolled in the population-based colorectal cancer screening program with a positive fecal occult blood test.
* Minors or elderly patients (over 80 years of age).
* Patients with prior colorectal surgery.
* Patients who, in the opinion of the researcher, will not be able to commit to follow-up or lack adequate technological skills.
* Inability to provide adequate informed consent.

Primary outcomes:
measure: Percentage of patients scheduled colonoscopy who have an adequate bowel preparation.
timeFrame: Day 0, (Colonoscopy Day)
Secondary outcomes:
measure: Active Patient Rate
timeFrame: Day -14 (14 days before the colonoscopy)
measure: Patients with section completed: Treatments
timeFrame: Day -14 (14 days before the colonoscopy)
measure: Patients with section completed: Pick up the bowel preparation
timeFrame: Day -10 (10 days before colonoscopy)
measure: Patients with section completed: Colonoscopy Preparation Solution (laxative).
timeFrame: Day 2 (2 days after colonoscopy)
measure: Patients with section completed: Procedure satisfaction questionnaire
timeFrame: Day 3 (3 days after colonoscopy)
measure: Patients with section completed: Adverse Events
timeFrame: Day 1, Day 14 and Day 30
measure: Percentage of patients with 100% of data completed
timeFrame: Day 31 (31days after the colonoscopy)
measure: Patients who view educational materials: Pick up the laxative
timeFrame: Day -10 (10 days before colonoscopy)
measure: Patients who view educational materials: Diet
timeFrame: Day -4 (4 days before colonoscopy)
measure: Patients who view educational materials: Adequate preparation for a colonoscopy
timeFrame: Day -4 (4 days before colonoscopy)
measure: Patients who view educational materials: Bring someone
timeFrame: Day -4 (4 days before colonoscopy)
measure: Patients who view educational materials: Instructions for your colonoscopy
timeFrame: Day -3 (3 days before colonoscopy)
measure: Percentage of patients with 100% of education materials viewed.
timeFrame: Day 31 (31days after the colonoscopy)
measure: Percentage of patients who take the laxative
timeFrame: Day -3 (3 days before the colonoscopy)
measure: Patient satisfaction with the bowel preparation (laxative)
timeFrame: Day 2 (2 days after colonoscopy)
measure: Patient satisfaction with the colonoscopy experience
timeFrame: Day 3 (3 days after colonoscopy)
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
Study officials:
References: