NCT02511314

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 30, 2015

Completed
2.4 years until next milestone

Study Start

First participant enrolled

January 2, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
Last Updated

January 25, 2021

Status Verified

January 1, 2021

Enrollment Period

1.8 years

First QC Date

May 12, 2015

Last Update Submit

January 22, 2021

Conditions

Urinary Incontinence

Keywords

Nursing homesquasi-experimentalmixed methodsparallel studyurinary incontinence

Outcome Measures

Primary Outcomes (1)

  • Between group change in the proportion of residents with a one category change in continence products usage

    8 weeks

Secondary Outcomes (10)

  • 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

  • +5 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control Intervention

NO 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.

Interventions

TENA IdentifiDEVICE

TENA Identifi

Intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Edmonton, Alberta, T6G 2P4, Canada

Location

Related Publications (5)

  • 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.

    PMID: 24479697BACKGROUND

  • 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.

    PMID: 15867743BACKGROUND

  • 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.

    PMID: 19191259BACKGROUND

  • 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.

    PMID: 22182302BACKGROUND

  • 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.

    PMID: 36640164DERIVED

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Adrian S Wagg, MD

    University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Chair in Healthy Aging

Study Record Dates

First Submitted

May 12, 2015

First Posted

July 30, 2015

Study Start

January 2, 2018

Primary Completion

October 30, 2019

Study Completion

March 30, 2020

Last Updated

January 25, 2021

Record last verified: 2021-01

Locations

CA(1)