Observational study of people living with an ostomy
Observational Study of Ostomy Consumers
This study is collecting feedback from people with ostomies and their caregivers over seven years to better understand their experiences and improve ostomy care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hollister Incorporated Industry-sponsored |
| Locations | 1 site (Libertyville, Illinois) |
| Trial ID | NCT03715179 on ClinicalTrials.gov |
What this trial studies
This longitudinal observational study aims to collect electronic Patient Reported Outcome (ePRO) data from individuals living with an ostomy and their caregivers over a 7-year period. Participants will self-report on their experiences with ostomy pouching systems, skin health, quality of life, caregiver burden, and product satisfaction. The study is designed to provide valuable insights into the patient and caregiver perspectives, which will inform healthcare providers and industry decision-making. The research does not test specific hypotheses but focuses on gathering real-world data to enhance understanding of ostomy care.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a single ileostomy, colostomy, or urostomy who can provide informed consent and complete monthly online questionnaires.
Not a fit: Patients who do not have an ostomy or those unable to provide informed consent due to cognitive impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved products and support systems for individuals living with an ostomy.
How similar studies have performed: While observational studies in this area are common, this specific ePRO registry approach is relatively novel and aims to fill gaps in understanding patient experiences.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Libertyville, Illinois
- Hollister Incorporated — Libertyville, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Renee Malandrino, MSN RN CWOCN — Hollister Incorporated
- Study coordinator: Manager Global Clinical Affairs
- Email: mackenzie.juckett@hollister.com
- Phone: +18479321845
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.