Observational Study of Ostomy Consumers

NCT03715179 | Active Not Recruiting

• 1 other identifier: 5878-O
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ostomy

Outcome Measures

Primary Outcomes (1)

• To create a patient reported outcomes registry of ostomy consumers

  To collect prospective observational data through a patient reported outcome (PRO) registry that will serve as a platform to conduct multiple analyses.

  7 years

Secondary Outcomes (2)

• Ostomy specific outcomes

  7 years

• Product specific outcomes

  7 years

Study Arms (1)

Ostomates

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Sponsor-curated customer databases and printed EC/IRB approved advertisements targeted to ostomy product consumers in the United States, Canada, and United Kingdom that may be distributed by clinicians, mail, website, conferences and other consumer contacts.

You may qualify if:

• 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
• Caregivers will be entered into this study only if they meet all of the following criteria:
• 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

You may not qualify if:

• Has more than one stoma
• Has a single stoma that has been reversed or closed

Sponsors & Collaborators

• Hollister Incorporated: lead

Study Sites (1)

Hollister Incorporated

Libertyville, Illinois, 60048, United States

Location

Related Publications (4)

• Colwell JC, Pittman J, Raizman R, Salvadalena G. A Randomized Controlled Trial Determining Variances in Ostomy Skin Conditions and the Economic Impact (ADVOCATE Trial). J Wound Ostomy Continence Nurs. 2018 Jan/Feb;45(1):37-42. doi: 10.1097/WON.0000000000000389.

  PMID: 29300287 BACKGROUND

• International Organization for Standardization. ISO 14155:2011: Clinical investigation of medical devices for human subjects - Good clinical practice.

  BACKGROUND

• ISPE. Guidelines for good pharmacoepidemiology practices (GPP). Pharmacoepidemiol Drug Saf. 2008 Feb;17(2):200-8. doi: 10.1002/pds.1471. No abstract available.

  PMID: 17868186 BACKGROUND

• Scientific and Clinical Abstracts From WOCNext(R) 2022: Fort Worth, Texas diamond June 5-8, 2022. J Wound Ostomy Continence Nurs. 2022 May-Jun 01;49(3 Suppl 1):S1-S99. doi: 10.1097/WON.0000000000000882. No abstract available.

  PMID: 35639023 DERIVED

Study Officials

• Renee Malandrino, MSN RN CWOCN

  Hollister Incorporated

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2018
• First Posted: October 23, 2018
• Study Start: October 4, 2018
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)