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

Urinary Incontinence Clinical Trial

— ARCTICC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02511314
• Other study ID #: ARC-NH-1205
• Status: Completed
• Phase: N/A
• Start date: January 2, 2018
• Est. completion date: March 30, 2020

Study information

• Verified date: January 2021
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: March 30, 2020
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence

Intervention

Device:
• TENA Identifi
TENA Identifi

Locations

Country	Name	City	State
Canada	Division of Geriatric Medicine, Clinical Sciences Building, University of Alberta Hosp	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	SCA Hygiene Products, AB

Country where clinical trial is conducted

Canada, 

References & Publications (4)

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

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