NCT03628833

Brief Summary

The objective of this Field Evaluation is to assess usage and satisfaction associated with the Hill-Rom Incontinence Management System.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

July 10, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 14, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 3, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2018

Completed
Last Updated

January 11, 2019

Status Verified

August 1, 2018

Enrollment Period

5 months

First QC Date

July 9, 2018

Last Update Submit

January 9, 2019

Conditions

Urinary IncontinenceFecal Incontinence

Outcome Measures

Primary Outcomes (1)

  • Staff satisfaction surveys on product performance

    Following product use, staff can complete an optional, Likert scale survey

    Through study completion, an average of 4 months

Secondary Outcomes (1)

  • Patient exposure time following an incontinence event

    Through study completion, an average of 4 months

Study Arms (1)

Incontinence Management system

EXPERIMENTAL
Device: Incontinence Management System

Interventions

Incontinence Management SystemDEVICE

Incontinence detection device

Incontinence Management system

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with urinary, fecal, or dual incontinence who are ≥ 18 years old
  • The patient, or the patient's legal authorized representative (LAR), is willing and able to provide written informed consent

You may not qualify if:

  • \- Patients that are considered to be near death or require palliative care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Joseph Hospital

Lexington, Kentucky, 40504, United States

Location

MeSH Terms

Conditions

Urinary IncontinenceFecal Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsRectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2018

First Posted

August 14, 2018

Study Start

July 10, 2018

Primary Completion

December 3, 2018

Study Completion

December 3, 2018

Last Updated

January 11, 2019

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)