Observational Study of Ostomy Consumers

Launched by HOLLISTER INCORPORATED · Oct 19, 2018

Keywords

ClinConnect Summary

This clinical trial is called the "Observational Study of Ostomy Consumers," and its main goal is to gather information directly from people who have an ostomy, as well as their caregivers, over a five-year period. An ostomy is a surgical procedure that creates an opening (stoma) in the body for waste to leave. Participants will fill out an online questionnaire once a month to share their experiences, including the types of pouching systems they use and other aspects of daily life with an ostomy. This information will help researchers understand how living with an ostomy affects individuals and their caregivers.

To participate, you need to be at least 18 years old and have a single ostomy (like an ileostomy, colostomy, or urostomy). You should be able to give informed consent, meaning you understand the study and agree to take part, and you can complete the monthly surveys yourself or have someone help you. Caregivers can also join the study if they support someone with an ostomy regularly. This research aims to improve the quality of life for ostomy patients and their caregivers, so your experiences and insights will be very valuable.

Gender

ALL

Eligibility criteria

• 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