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

Primary Purpose

Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
TENA Identifi
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Urinary Incontinence focused on measuring Nursing homes, quasi-experimental, mixed methods, parallel study, urinary incontinence

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control Intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 12, 2015
Last Updated
January 22, 2021
Sponsor
University of Alberta
Collaborators
SCA Hygiene Products, AB
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1. Study Identification

Unique Protocol Identification Number
NCT02511314
Brief Title
A Trial of effectIveness of a Smart Sensor for Continence Care: the ARCTICC Study
Acronym
ARCTICC
Official Title
A Randomised, Controlled Trial of effectIveness of a Smart Sensor for Continence Care: the ARCTICC Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 2, 2018 (Actual)
Primary Completion Date
October 30, 2019 (Actual)
Study Completion Date
March 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alberta
Collaborators
SCA Hygiene Products, AB

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
Keywords
Nursing homes, quasi-experimental, mixed methods, parallel study, urinary incontinence

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Intervention
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
TENA Identifi
Intervention Description
TENA Identifi
Primary Outcome Measure Information:
Title
Between group change in the proportion of residents with a one category change in continence products usage
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Between group change in time for construction of continence care plan following assessment
Time Frame
8 weeks
Title
Between group change in number of pads used
Time Frame
8 weeks
Title
Between group change in proportion of residents with pad leakage episodes
Time Frame
8 weeks
Title
Between group change in change in cost of continence products
Time Frame
8 weeks
Title
Between group change in change in healthcare aide / personal support worker time spent in continence care
Time Frame
8 weeks
Title
Between group change in Quality of life, measured by QoL AD
Time Frame
8 weeks
Title
Between group change in Activities of daily living as measured by Barthel index
Time Frame
8 weeks
Title
Between group change in number of wet checks at night
Time Frame
8 weeks
Title
Between group change in reduction in number of residents on "timed toileting schedules"
Time Frame
8 weeks
Title
Utility and acceptability of the Tena Identifi system by the end-user through a Focus Group
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrian S Wagg, MD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Geriatric Medicine, Clinical Sciences Building, University of Alberta Hosp
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2P4
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
24479697
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.
Results Reference
background
PubMed Identifier
15867743
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.
Results Reference
background
PubMed Identifier
19191259
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.
Results Reference
background
PubMed Identifier
22182302
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.
Results Reference
background

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

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