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A Pilot Clinical Trial of TENA Identifi in the Nursing Home Setting

NCT03209570 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2019-07-26

Study results available
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Summary

The purpose of this study is to prospectively compare a standard of care manual toileting protocol (e.g., "check and change" strategy) to toileting patterns recorded by the TENA Identifi system in identifying incontinence patterns and events, and, whether such data differentially improve a care planning strategy, nursing effort, product use, and wet-time for urinary incontinence.

Conditions

Interventions

OTHER

Care planning using TENA Identifi sensor wear data

All individuals in this arm will receive TENA Identifi sensor wear and will have data available for care planning.

OTHER

Care planning without using TENA Identifi sensor wear data

All individuals in this arm will receive TENA Identifi sensor wear but the sensor wear data will not be used for care planning.

Sponsors & Collaborators

  • Essity Hygiene and Health AB

    collaborator INDUSTRY

  • Insight Therapeutics, LLC

    lead OTHER

Principal Investigators

  • Stefan Gravenstein, MD, MPH · Brown University

  • H Edward Davidson, PharmD, MPH · Insight Therapeutics, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-19
Primary Completion
2018-08-11
Completion
2018-08-11

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03209570 on ClinicalTrials.gov