Observational Study of Ostomy Consumers

Study Overview
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Brief Summary
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The purpose of this longitudinal prospective observational study is to collect electronic Patient Reported Outcome (ePRO) data over a 5-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). 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
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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.

Official Title
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Observational Study of Ostomy Consumers

Conditions
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Ostomy

Intervention / Treatment
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* Device: Ostomy Pouching System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is at least 18 years of age; any self-reported gender Has a single Ileostomy, Colostomy, or Urostomy 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 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 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: Is at least 18 years of age; any self-reported gender Is an informal supporter (such as a relative, friend, or neighbor) of the care recipient 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: Has more than one stoma Has a single stoma that has been reversed or closed

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Standard of Care<br>Individuals living with an ostomy and their caregivers. Participants use their own ostomy pouching systems per their clinician's standard of care | Device: Ostomy Pouching System<br>* An ostomy pouching system is a medical device that provides a means for the collection of effluent from a surgically diverted biological system (colon, ileum, bladder), specifically from a stoma. No intervention is administered during the course of this study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To create a patient reported outcomes registry of ostomy consumers | To collect prospective observational data through a patient reported outcome (PRO) registry that will serve as a platform to conduct multiple analyses. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ostomy specific outcomes | To identify and characterize ostomy specific outcomes for the purposes of hypothesis generation. | 5-years | 
| Product specific outcomes | To identify and characterize product specific outcomes related to the ostomy specific outcomes. | 5 years |