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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ostomates | Individuals living with an ostomy and their caregivers. Participants use their own ostomy pouching systems per their clinician's standard of care |
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| 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. | 7 years |
| Measure | Description | Time Frame |
|---|---|---|
| Ostomy specific outcomes | To identify and characterize ostomy specific outcomes for the purposes of hypothesis generation. | 7 years |
| Product specific outcomes | To identify and characterize product specific outcomes related to the ostomy specific outcomes. |
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Inclusion Criteria:
Caregivers will be entered into this study only if they meet all of the following criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Renee Malandrino, MSN RN CWOCN | Hollister Incorporated | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hollister Incorporated | Libertyville | Illinois | 60048 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29300287 | Background | 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. | |
| Background | International Organization for Standardization. ISO 14155:2011: Clinical investigation of medical devices for human subjects - Good clinical practice. | ||
| 17868186 |
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| 7 years |
| 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. |
| 35639023 | Derived | 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. |