Stoma Ileostomy
Conditions
Brief summary
This study aims to longitudinally evaluate the usage and long-term benefits of the CE-marked device, Heylo™, a digital leakage notification system for people with intestinal stomas. The system, which includes a smartphone application, an adhesive sensor layer, and a Bluetooth transmitter, notifies users of changes in their baseplate status, potentially reducing stoma effluent leakage and improving quality of life. The physical Heylo™ device, is part of the Coloplast Charter telehealth service.
Interventions
None listed
Sponsors
Coloplast A/S
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Are you at least 18 years old? \[Yes/No\] 2. Do you have an ileostomy or a colostomy? \[Yes/No\] 3. Have you used Heylo™ for less than seven days? \[Yes/No\]
Exclusion criteria
1\) Do you have a stoma reversal planned (surgery date within the next 6 months)? Yes/No\]
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary endpoint | one year | Stoma-related QoL measured by the Emotional Leakage Impact score (domain 1 of OLI) at baseline (0 months), 6, 9 and 12 months |
Countries
Denmark
Contacts
Primary ContactThomas Krarup Simonsen
Outcome results
None listed