Observational Study of Ostomy Consumers

Ostomy Clinical Trial

— OSO  

Official title:

Observational Study of Ostomy Consumers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03715179
• Other study ID #: 5878-O
• Status: Recruiting
• Start date: October 4, 2018
• Est. completion date: February 2025

Study information

• Verified date: May 2024
• Source: Hollister Incorporated
• Contact: Manager Global Clinical Affairs
• Phone: +18479321845
• Email: mackenzie.juckett[@]hollister.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ostomy

Intervention

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.

Locations

Country	Name	City	State
United States	Hollister Incorporated	Libertyville	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Hollister Incorporated

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Ostomy specific outcomes	To identify and characterize ostomy specific outcomes for the purposes of hypothesis generation.	5-years
Secondary	Product specific outcomes	To identify and characterize product specific outcomes related to the ostomy specific outcomes.	5 years