Observational Study of Ostomy Consumers (NCT03715179) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Observational Study of Ostomy Consumers
United States5,000 participantsStarted 2018-10-04
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
✓. 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
What they're measuring
1
To create a patient reported outcomes registry of ostomy consumers