CP384 - Ostomy Care (OC) PRO Panel Plan
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorColoplast A/S
About this trial
The aim is to create an electronic patient reported outcome (e-PRO) based registry, specifically for subjects living with a stoma (ileostomy, colostomy or urostomy).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years of age or above
full legal capacity
willing and able to complete online questionnaires
have either an ileostomy, a colostomy, or a urostomy
Disqualifiers
Cannot have a scheduled stoma reversal surgery
Cannot have more than one stoma
Trial population
Ostomy users will be included in this registry. The registry will be conducted across seven countries: United Kingdom, United States, Denmark, France, Italy, Sweden, and Germany, enrolling a minimum of 1,000 OC users.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
1,000 Participants
are grouped into 1 trial groupGroup A: Other: No Intervention: Observational Cohort
Trial outcomes
Primary outcomes
1
Number of OC products used by subjects.
Characterization of a cohort of ostomy care (OC) users at point-of-entry to the registry including e.g., but not limited to OC product consumption, user-patterns, and use of supporting products.
Time frame
5 years2
The number of leakage events
Frequency and consequences of leakages and Peristomal Skin Complications (PSC).
Time frame
5 years3
The Mental well-being index (WHO-5)
Quality-of-life (QoL) using the Mental well-being index (WHO-5). The subject has 5 questions asked, with 6 different responses available: "All of the time", "Most of the time", "More than half the time", "less than half the time", "some of the time", and "at no time". The choice of "all of the time" equates to a better well-being than a response of "at no time".
Time frame
5 yearsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Coloplast A/S
Lead sponsor
IQVIA Pty Ltd
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: