Observational Study of Ostomy Consumers (OSO)

Hollister

Status: Active, not recruiting

Conditions: Ostomy

Treatments: Device: Ostomy Pouching System

Study type: Observational

Funder types: Industry

Identifiers

NCT03715179

5878-O

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

5,000 participants in 1 patient group

Ostomates

Description:

Individuals living with an ostomy and their caregivers. Participants use their own ostomy pouching systems per their clinician's standard of care