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Completed

NCT Number: NCT02511314

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

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.

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Key information

Conditions

Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Edmonton, Alberta, T6G 2P4, Canada

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TENA Identifi

Device

TENA Identifi

Primary outcomes

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

    Time frame: 8 weeks

Secondary outcomes

  1. Between group change in time for construction of continence care plan following assessment

    Time frame: 8 weeks

  2. Between group change in number of pads used

    Time frame: 8 weeks

  3. Between group change in proportion of residents with pad leakage episodes

    Time frame: 8 weeks

  4. Between group change in change in cost of continence products

    Time frame: 8 weeks

  5. Between group change in change in healthcare aide / personal support worker time spent in continence care

    Time frame: 8 weeks

  6. Between group change in Quality of life, measured by QoL AD

    Time frame: 8 weeks

  7. Between group change in Activities of daily living as measured by Barthel index

    Time frame: 8 weeks

  8. Between group change in number of wet checks at night

    Time frame: 8 weeks

  9. Between group change in reduction in number of residents on "timed toileting schedules"

    Time frame: 8 weeks

  10. Utility and acceptability of the Tena Identifi system by the end-user through a Focus Group

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • SCA Hygiene Products, AB

Registry information

Official study title

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

Acronym: ARCTICC

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jul 30, 2015
Registry last updated
Jan 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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