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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02511314
Acronym
ARCTICC
Enrollment
89
Registered
2015-07-30
Start date
2018-01-02
Completion date
2020-03-30
Last updated
2021-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Incontinence

Keywords

Nursing homes, quasi-experimental, mixed methods, parallel study, urinary incontinence

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.

Interventions

DEVICETENA Identifi

TENA Identifi

Sponsors

SCA Hygiene Products, AB
CollaboratorUNKNOWN
University of Alberta
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Between group change in the proportion of residents with a one category change in continence products usage8 weeks

Secondary

MeasureTime frame
Between group change in number of pads used8 weeks
Between group change in proportion of residents with pad leakage episodes8 weeks
Between group change in change in cost of continence products8 weeks
Between group change in change in healthcare aide / personal support worker time spent in continence care8 weeks
Between group change in time for construction of continence care plan following assessment8 weeks
Between group change in Activities of daily living as measured by Barthel index8 weeks
Between group change in number of wet checks at night8 weeks
Between group change in reduction in number of residents on timed toileting schedules8 weeks
Utility and acceptability of the Tena Identifi system by the end-user through a Focus Group8 weeks
Between group change in Quality of life, measured by QoL AD8 weeks

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026