Clinical trial NCT03715179: Observational Study of Ostomy Consumers
Official title: Observational Study of Ostomy Consumers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ostomy
Lead sponsor: Hollister Incorporated
Sponsor class: INDUSTRY
First posted: 2018-10-23
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

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

Primary outcomes:
measure: To create a patient reported outcomes registry of ostomy consumers
timeFrame: 7 years
Secondary outcomes:
measure: Ostomy specific outcomes
timeFrame: 7 years
measure: Product specific outcomes
timeFrame: 7 years
Other outcomes:
Locations:
city: Libertyville
country: United States
facility: Hollister Incorporated
state: Illinois
Study officials:
affiliation: Hollister Incorporated
name: Renee Malandrino, MSN RN CWOCN
role: PRINCIPAL_INVESTIGATOR
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.
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.
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.