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

Not Applicable

Completed

• Conditions: Urinary Incontinence
• Interventions: Device: TENA Identifi

• Registration Number: NCT02511314
• Lead Sponsor: University of Alberta

Brief Summary

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.

Detailed Description

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-05-12
• Study First Submitted QC: 2015-07-27
• Study First Posted: 2015-07-30
• Study Start: 2018-01-02
• Primary Completion: 2019-10-30
• Study Completion: 2020-03-30
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-22
• Last Update Posted: 2021-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	TENA Identifi	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.

Primary Outcome Measures

Name	Time	Method
Between group change in the proportion of residents with a one category change in continence products usage	8 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Division of Geriatric Medicine, Clinical Sciences Building, University of Alberta Hosp; 🇨🇦 Edmonton, Alberta, Canada