Clinical trial NCT02511314: A Trial of effectIveness of a Smart Sensor for Continence Care: the ARCTICC Study
Official title: A Randomised, Controlled Trial of effectIveness of a Smart Sensor for Continence Care: the ARCTICC Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Keywords: Nursing homes
quasi-experimental
mixed methods
parallel study
urinary incontinence
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: SCA Hygiene Products, AB
First posted: 2015-07-30
Enrollment: 89
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Between group change in the proportion of residents with a one category change in continence products usage
timeFrame: 8 weeks
Secondary outcomes:
measure: Between group change in time for construction of continence care plan following assessment
timeFrame: 8 weeks
measure: Between group change in number of pads used
timeFrame: 8 weeks
measure: Between group change in proportion of residents with pad leakage episodes
timeFrame: 8 weeks
measure: Between group change in change in cost of continence products
timeFrame: 8 weeks
measure: Between group change in change in healthcare aide / personal support worker time spent in continence care
timeFrame: 8 weeks
measure: Between group change in Quality of life, measured by QoL AD
timeFrame: 8 weeks
measure: Between group change in Activities of daily living as measured by Barthel index
timeFrame: 8 weeks
measure: Between group change in number of wet checks at night
timeFrame: 8 weeks
measure: Between group change in reduction in number of residents on "timed toileting schedules"
timeFrame: 8 weeks
measure: Utility and acceptability of the Tena Identifi system by the end-user through a Focus Group
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Division of Geriatric Medicine, Clinical Sciences Building, University of Alberta Hosp
state: Alberta
Study officials:
affiliation: University of Alberta
name: Adrian S Wagg, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
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.