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

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

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

Conditions
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Urinary Incontinence

Intervention / Treatment
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* Device: TENA Identifi


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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<br>* TENA Identifi<br>|
| No Intervention: Control Intervention<br>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?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 proportion of residents with pad leakage episodes |  | 8 weeks | 
| Between group change in change in cost of continence products |  | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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urinary incontinence, Nursing homes, quasi-experimental, mixed methods, parallel study