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

NCT ID: NCT02511314

Last Updated: 2021-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-02

Study Completion Date

2020-03-30

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.

Conditions

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Urinary Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

TENA Identifi

Intervention Type DEVICE

TENA Identifi

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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TENA Identifi

TENA Identifi

Intervention Type DEVICE

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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SCA Hygiene Products, AB

UNKNOWN

Sponsor Role collaborator

University of Alberta

OTHER

Sponsor Role lead

Responsible Party

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Adrian Wagg

Research Chair in Healthy Aging

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Adrian S Wagg, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

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Division of Geriatric Medicine, Clinical Sciences Building, University of Alberta Hosp

Edmonton, Alberta, Canada

Site Status

Countries

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Canada

References

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Yu P, Hailey D, Fleming R, Traynor V. An exploration of the effects of introducing a telemonitoring system for continence assessment in a nursing home. J Clin Nurs. 2014 Nov;23(21-22):3069-76. doi: 10.1111/jocn.12538. Epub 2014 Jan 31.

Reference Type BACKGROUND
PMID: 24479697 (View on PubMed)

Nikoletti S, Young J, King M. Evaluation of an electronic monitoring device for urinary incontinence in elderly patients in an acute care setting. J Wound Ostomy Continence Nurs. 2004 May-Jun;31(3):138-49. doi: 10.1097/00152192-200405000-00008.

Reference Type BACKGROUND
PMID: 15867743 (View on PubMed)

Offermans MP, Du Moulin MF, Hamers JP, Dassen T, Halfens RJ. Prevalence of urinary incontinence and associated risk factors in nursing home residents: a systematic review. Neurourol Urodyn. 2009;28(4):288-94. doi: 10.1002/nau.20668.

Reference Type BACKGROUND
PMID: 19191259 (View on PubMed)

Roe B, Flanagan L, Jack B, Shaw C, Williams K, Chung A, Barrett J. Systematic review of descriptive studies that investigated associated factors with the management of incontinence in older people in care homes. Int J Older People Nurs. 2013 Mar;8(1):29-49. doi: 10.1111/j.1748-3743.2011.00300.x. Epub 2011 Dec 19.

Reference Type BACKGROUND
PMID: 22182302 (View on PubMed)

Rajabali SN, Hunter KF, Asaana P, McCreary ML, Nazari S, Wagg AS. Effectiveness of a Smart Urinary Continence Care Assessment System for Nursing Home Residents: A Quasi-Experimental, Sequential Quantitative-Qualitative Methods Trial. J Wound Ostomy Continence Nurs. 2023 Jan-Feb 01;50(1):48-56. doi: 10.1097/WON.0000000000000937.

Reference Type DERIVED
PMID: 36640164 (View on PubMed)

Other Identifiers

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ARC-NH-1205

Identifier Type: -

Identifier Source: org_study_id

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