Study to Analyse the Use of a Digital Platform for the Preparation and Follow-up of Patients With Scheduled Outpatients Colonoscopy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Outpatient Colonoscopy. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Observational Study of the Digital Platform Use for the Preparation and Monitoring of Patients With Scheduled Outpatient Colonoscopy
Overview
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.
Primary outcome measures
- Percentage of patients scheduled colonoscopy who have an adequate bowel preparation. [Time frame: Day 0, (Colonoscopy Day)]
Secondary outcome measures (12)
- Active Patient Rate [Time frame: Day -14 (14 days before the colonoscopy)]
- Patients with section completed: Treatments [Time frame: Day -14 (14 days before the colonoscopy)]
- Patients with section completed: Pick up the bowel preparation [Time frame: Day -10 (10 days before colonoscopy)]
- Patients with section completed: Colonoscopy Preparation Solution (laxative). [Time frame: Day 2 (2 days after colonoscopy)]
- Patients with section completed: Procedure satisfaction questionnaire [Time frame: Day 3 (3 days after colonoscopy)]
- Patients with section completed: Adverse Events [Time frame: Day 1, Day 14 and Day 30]
- Percentage of patients with 100% of data completed [Time frame: Day 31 (31days after the colonoscopy)]
- Patients who view educational materials: Pick up the laxative [Time frame: Day -10 (10 days before colonoscopy)]
- Patients who view educational materials: Diet [Time frame: Day -4 (4 days before colonoscopy)]
- Patients who view educational materials: Adequate preparation for a colonoscopy [Time frame: Day -4 (4 days before colonoscopy)]
- Patients who view educational materials: Bring someone [Time frame: Day -4 (4 days before colonoscopy)]
- Patients who view educational materials: Instructions for your colonoscopy [Time frame: Day -3 (3 days before colonoscopy)]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Spain · 1 center
- Hospital Clínic de Barcelona — Barcelona
Identifiers
NCT: NCT06916052 · COLObs