Ostomy
Conditions
Brief summary
The purpose of this longitudinal prospective observational study is to collect electronic Patient Reported Outcome (ePRO) data over a 7-year period directly from people living with an ostomy and their caregivers (participants were re-consented with version 3 of the Protocol in 2020 which indicated a study duration of 5 years, and version 6 of the Protocol in 2025 extending for an additional 2 years). Research participants will be asked to self-report on the ostomy pouching systems they typically use and other various aspects of living with an ostomy and/or caring for an individual living with an ostomy.
Detailed description
This longitudinal prospective observational study is designed as an ePRO registry to collect data from consumers with an ostomy (ileostomy, colostomy, or urostomy) in the United States, Canada, and United Kingdom. An ePRO registry provides a relevant data source founded on the patient's voice. As such, an ePRO registry will be invaluable for prospective observational research aiming to investigate associations of ostomy pouching systems (inclusive of accessories) with peristomal skin health, participant QoL, caregiver burden, product satisfaction, and Healthcare Resource Utilization (HRU). Information from this registry will inform and guide industry healthcare providers and payers in decision-making and subsequent research that factors in the patient and caregiver perspectives. The current study does not test any specific a priori hypotheses.
Interventions
None listed
Sponsors
Hollister Incorporated
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Is at least 18 years of age; any self-reported gender 2. Has a single Ileostomy, Colostomy, or Urostomy 3. Is able to provide an informed consent for study participation with no cognitive impairment that would hinder the ability to provide informed consent or provide self-reported data 4. Is willing and able to complete a once per month online questionnaire about life with an ostomy, or has a proxy who can enter data on their behalf 5. Are able to respond themselves or appoint a caregiver as a proxy to respond to online computer questionnaires in English, French Canadian, or Spanish Caregivers will be entered into this study only if they meet all of the following criteria: 1. Is at least 18 years of age; any self-reported gender 2. Is an informal supporter (such as a relative, friend, or neighbor) of the care recipient 3. Provides support to the care recipient in some capacity (such as ordering supplies or pouch changes) on average at least once per week
Exclusion criteria
1. Has more than one stoma 2. Has a single stoma that has been reversed or closed
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To create a patient reported outcomes registry of ostomy consumers | 7 years | To collect prospective observational data through a patient reported outcome (PRO) registry that will serve as a platform to conduct multiple analyses. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ostomy specific outcomes | 7 years | To identify and characterize ostomy specific outcomes for the purposes of hypothesis generation. |
| Product specific outcomes | 7 years | To identify and characterize product specific outcomes related to the ostomy specific outcomes. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRenee Malandrino, MSN RN CWOCN
Hollister Incorporated
Outcome results
None listed