Observational Study of Ostomy Consumers (OSO)

The purpose of this longitudinal prospective observational study is to collect electronic Patient Reported Outcome (ePRO) data over a 5-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). 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.

Study Overview

• Status: Recruiting
• Conditions: Ostomy
• Intervention / Treatment: Device: Ostomy Pouching System

Detailed Description

This longitudinal prospective observational study is designed as an ePRO registry to collect data from consumers with an ostomy (ileostomy, colostomy, or urostomy) in the United States, Canada, and United Kingdom. An ePRO registry provides a relevant data source founded on the patient's voice. As such, an ePRO registry will be invaluable for prospective observational research aiming to investigate associations of ostomy pouching systems (inclusive of accessories) with peristomal skin health, participant QoL, caregiver burden, product satisfaction, and Healthcare Resource Utilization (HRU). Information from this registry will inform and guide industry healthcare providers and payers in decision-making and subsequent research that factors in the patient and caregiver perspectives. The current study does not test any specific a priori hypotheses.

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Manager Global Clinical Affairs; Phone Number: +18479321845; Email: mackenzie.juckett@hollister.com

Study Locations

• United States
  • Illinois
    • Libertyville, Illinois, United States, 60048
      • Recruiting
      • Hollister Incorporated
      • Contact: Renee Malandrino, MSN RN CWOCN; Phone Number: 847-996-3061; Email: renee.malandrino@hollister.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Standard of Care; Individuals living with an ostomy and their caregivers. Participants use their own ostomy pouching systems per their clinician's standard of care	Device: Ostomy Pouching System; An ostomy pouching system is a medical device that provides a means for the collection of effluent from a surgically diverted biological system (colon, ileum, bladder), specifically from a stoma. No intervention is administered during the course of this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ostomy specific outcomes	To identify and characterize ostomy specific outcomes for the purposes of hypothesis generation.	5-years
Product specific outcomes	To identify and characterize product specific outcomes related to the ostomy specific outcomes.	5 years

Collaborators and Investigators

• Sponsor: Hollister Incorporated
• Investigators: Principal Investigator: Renee Malandrino, MSN RN CWOCN, Hollister Incorporated

Publications and helpful links

General Publications

• 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.
• International Organization for Standardization. ISO 14155:2011: Clinical investigation of medical devices for human subjects - Good clinical practice.
• ISPE. Guidelines for good pharmacoepidemiology practices (GPP). Pharmacoepidemiol Drug Saf. 2008 Feb;17(2):200-8. doi: 10.1002/pds.1471. No abstract available.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2018
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: October 19, 2018
• First Submitted That Met QC Criteria: October 19, 2018
• First Posted (Actual): October 23, 2018

Study Record Updates

• Last Update Posted (Actual): August 28, 2023
• Last Update Submitted That Met QC Criteria: August 24, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 5878-O

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes