People with a stoma Digestive System
Conditions
Interventions
The investigation is a cross-sectional, multi-centred study, evaluating the burden of disease by an interview and online questionnaire with an expected duration of 1 week. All visits will be planned t
2) collecting demographic information, healthcare utilisation and peristomal skin condition information
3) training the subjects on the online survey system and 4) subjects completing baseline questions in the online survey system.
Further surveys will be accessed by the patient in the online system a
Sponsors
Coloplast UK & Ireland Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Have given written informed consent 2. Be at least 18 years of age and have full legal capacity 3. Have had their stoma for less than 12 months 4. Ileo- or colostomists with liquid and/or mushy output (Bristol scale type 5-7) 5. Have intact skin on the peristomal area (assessed by investigator) 6. Have been self-managing stoma appliance for at least 14 days. 7. Must be able to complete the online survey via the EDC system
Exclusion criteria
Exclusion criteria: 1. Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tab-let/injection) treatment. 2. Have previously participated in this investiga-tion. 3. Patients with a complicated stoma at baseline (dehiscence/prolapse/hernia) 4. Having more than one abdominal stoma simul-taneously present. 5. Ongoing non-healed abdominal wounds 6. Reoperation / stoma reversal planned prior to completion of first study visit or questionnaire assessments. 7. Limited life expectancy / palliative care patients 8. Stage 4 cancer patients 9. Enrolment into an interventional stoma/stoma device trial within the last 12 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient-reported number of times with stoma effluent leakage outside the baseplate (e.g. onto clothes or bed sheets) within the last 2 weeks, collected using an online survey completed by subjects within 48 hours of nurse-led interview visit (Visit 1). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Leakage-related quality of life & Impact, measured using Ostomy Lead Impact (OLI) questionnaire within 48 hours of nurse-led interview visit (Visit 1) 2. Patient self-management, measured using Patient Activation Measurement (PAM) questionnaire within 48 hours of nurse-led interview visit (Visit 1) 3. Health-related quality of life, measured using EQ-5D-5L questionnaire within 48 hours of nurse-led interview visit (Visit 1) 4. Peristomal skin condition measured using Decision Tree Score based on Ostomy Skin Tool 2.0 at nurse-led interview visit (Visit 1) and online survey within 48 hours of nurse-led interview visit (Visit 1) 5. Mental wellbeing measured using WHO-5 Well-Being Index within 48 hours of nurse-led interview visit (Visit 1) 6. Worry about leakage and actions taken when worrying using online survey within 48 hours of nurse-led interview visit (Visit 1) 7. Odor assessed using online survey within 48 hours of nurse-led interview visit (Visit 1) 8. Changing routine (wear time,reason for change and accessories use) assessed using online survey within 48 hours of nurse-led interview visit (Visit 1) 9. Unplanned changes due to leakage worry assessed using online survey within 48 hours of nurse-led interview visit (Visit 1) 10. Self-management (feeling of security, confidence in knowing when to change appliance and confidence at night) assessed using online survey within 48 hours of nurse-led interview visit (Visit 1) 11. Impact of leakage on work (sick days), sleep and social activities (2 week recall) assessed using online survey within 48 hours of nurse-led interview visit (Visit 1) 12. Healthcare resource utilisation (2 week recall) assessed at nurse-led interview visit (Visit 1) | — |
Countries
England, United Kingdom
Contacts
Public ContactRebecca Mather
Outcome results
None listed