Observational Study of Ostomy Consumers

Description

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.

Conditions

Ostomy

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Study Overview

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Study Details

Study overview

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.

Observational Study of Ostomy Consumers

Observational Study of Ostomy Consumers

Condition
Ostomy
Intervention / Treatment

-

Contacts and Locations

Libertyville

Hollister Incorporated, Libertyville, Illinois, United States, 60048

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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
  • 1. Has more than one stoma
  • 2. Has a single stoma that has been reversed or closed

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Hollister Incorporated,

Renee Malandrino, MSN RN CWOCN, PRINCIPAL_INVESTIGATOR, Hollister Incorporated

Study Record Dates

2027-02