## Protocol Section
### Identification Module
**NCT ID:** NCT03715179

**Acronym:** OSO

**Brief Title:** Observational Study of Ostomy Consumers

**Official Title:** Observational Study of Ostomy Consumers

#### Organization Study ID Info
**ID:** 5878-O
#### Organization
**Class:** INDUSTRY
**Full Name:** Hollister Incorporated
### Status Module
#### Completion Date
**Date:** 2025-02

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-07

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-03

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-02

**Type:** ESTIMATED

#### Start Date
**Date:** 2018-10-04

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2018-10-23
**Type:** ACTUAL
**Study First Submit Date:** 2018-10-19
**Study First Submit QC Date:** 2018-10-19
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Hollister Incorporated

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** True

**Oversight Has DMC:** False

### Description Module

**Brief 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.

**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.

### Conditions Module

**Conditions:**

- Ostomy

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 600

**Type:** ESTIMATED

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 5 Years

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Device: Ostomy Pouching System

**Label:** Standard of Care

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Standard of Care

**Description:** 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.

**Name:** Ostomy Pouching System

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

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

**Measure:** To create a patient reported outcomes registry of ostomy consumers

**Time Frame:** 5 years

#### Secondary Outcomes

**Description:** To identify and characterize ostomy specific outcomes for the purposes of hypothesis generation.

**Measure:** Ostomy specific outcomes

**Time Frame:** 5-years

**Description:** To identify and characterize product specific outcomes related to the ostomy specific outcomes.

**Measure:** Product specific outcomes

**Time Frame:** 5 years

### Eligibility Module

**Eligibility 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

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**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.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** mackenzie.juckett@hollister.com

**Name:** Manager Global Clinical Affairs

**Phone:** +18479321845

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Libertyville

**Contacts:**

***Contact 1:***

- **Email:** renee.malandrino@hollister.com

- **Name:** Renee Malandrino, MSN RN CWOCN

- **Phone:** 847-996-3061

- **Role:** CONTACT

**Country:** United States

**Facility:** Hollister Incorporated

**State:** Illinois

**Status:** RECRUITING

**Zip:** 60048

#### Overall Officials

**Official 1:**

**Affiliation:** Hollister Incorporated

**Name:** Renee Malandrino, MSN RN CWOCN

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** 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

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

**Citation:** 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

**Citation:** 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 Section

### Intervention Browse Module - Browse Branches

- Abbrev: HB

- Name: Herbal and Botanical

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: T120

- Name: Cola

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
