A Trial of effectIveness of a Smart Sensor for Continence Care: the ARCTICC Study (ARCTICC)

January 22, 2021 updated by: Adrian Wagg, University of Alberta

A Randomised, Controlled Trial of effectIveness of a Smart Sensor for Continence Care: the ARCTICC Study

The purpose of this study is to compare the use of an electronic incontinence identification system with nursing home support (Tena Identifi) versus usual care on the quality, resource use and outcomes of continence care for older residents of nursing care homes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, quasi-experimental, controlled study with a mixed methods design with qualitative and quantitative components.

Study Type

Interventional

Enrollment (Actual)

89

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2P4
        • Division of Geriatric Medicine, Clinical Sciences Building, University of Alberta Hosp

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Nursing homes: A facility which:

    • provides care for residents over the age of 65 years
    • has an existing policy for continence care
    • is registered with the appropriate Provincial authorities
    • engages in recording of the RAI- MDS v2.0
  • Residents: Nursing home residents over the age of 65 requiring a continence assessment upon entry to the nursing home or requiring a reassessment because of either a change in clinical status or provincial requirement shall be eligible for entry

Exclusion Criteria:

  • Residents

    • at the end of life,
    • with profound behavioural disturbances likely to render the use of the Tena Identifi system impractical
    • an identifiable, potentially reversible cause for their urinary incontinence (e.g.: acute urinary tract infection)
    • with double incontinence dominated by faecal incontinence
  • Staff and Managers - Staff who did not take the training on the Identifi system or managers whose units that did not participate in the study will be ineligible for the focus group.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention

Tena Identifi is an integrated electronic monitoring system based upon a wearable continence pad which allows registration of resident's micturition patterns over a 72 hour period, allowing caregivers to construct an individualised continence care plan, including use of appropriate products.

To create a voiding report, a resident wears the Identifi Sensor Wear with an attached Identifi Logger for three consecutive days (72 hours). The logger continuously logs the moisture status of the brief. The resulting data is sent to a server via 3 G signal where it is mapped onto a graph indicating voiding times and volumes.
Device: TENA Identifi
TENA Identifi
No Intervention: Control Intervention
The control portion of the study is "usual care", defined as the routine practices and procedures, including continence assessment approach, prescribed in the nursing home unit or facility.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Between group change in the proportion of residents with a one category change in continence products usage
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Between group change in time for construction of continence care plan following assessment
Time Frame: 8 weeks
8 weeks
Between group change in number of pads used
Time Frame: 8 weeks
8 weeks
Between group change in proportion of residents with pad leakage episodes
Time Frame: 8 weeks
8 weeks
Between group change in change in cost of continence products
Time Frame: 8 weeks
8 weeks
Between group change in change in healthcare aide / personal support worker time spent in continence care
Time Frame: 8 weeks
8 weeks
Between group change in Quality of life, measured by QoL AD
Time Frame: 8 weeks
8 weeks
Between group change in Activities of daily living as measured by Barthel index
Time Frame: 8 weeks
8 weeks
Between group change in number of wet checks at night
Time Frame: 8 weeks
8 weeks
Between group change in reduction in number of residents on "timed toileting schedules"
Time Frame: 8 weeks
8 weeks
Utility and acceptability of the Tena Identifi system by the end-user through a Focus Group
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Collaborators

SCA Hygiene Products, AB

Investigators

  • Principal Investigator: Adrian S Wagg, MD, University of Alberta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2018

Primary Completion (Actual)

October 30, 2019

Study Completion (Actual)

March 30, 2020

Study Registration Dates

First Submitted

May 12, 2015

First Submitted That Met QC Criteria

July 27, 2015

First Posted (Estimate)

July 30, 2015

Study Record Updates

Last Update Posted (Actual)

January 25, 2021

Last Update Submitted That Met QC Criteria

January 22, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARC-NH-1205

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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