The Integration of Sensor Technology Into Incontinence Materials: a Single-group Pretest-posttest Study in a Nursing Home Environment (Smart Diapers)

June 21, 2023 updated by: University Ghent
The smart diaper aims to (1) detect humidity, (2) be capable of sending real-time indication of the saturation to the healthcare workers when urine loss occurs and (3) generate alerts when the diaper requires changing. Potential benefits of the smart diaper compared to incontinence management products without sensor technology include: workload reduction, increased comfort for residents and staff, more person-centred care, increased quality of care, less skin damage and economic (e.g. less costs due to less excessive diaper changes), and/or environmental (e.g. less waste) gains.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Oudenaarde, Belgium, 9700
        • WZC Heilig Hart vzw

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Resident of nursing home
  • Urinary incontinence or double incontinence (Katz score incontinence ≥ 3) by day and night. (Score assessed in one week interval before start study period 1 and 2 "D1")
  • Wearing adult diapers as incontinence material, size M.
  • Unable to change diaper independently when saturated or leaking (Katz score toileting ≥ 3). (Score assessed in one week interval before start study period 1 and 2 "D1")
  • Written informed consent from resident or resident's legal representative.
  • Dutch speaking

Exclusion Criteria:

  • Residents who are receiving end-of-life care
  • Residents with a Mini-Mental State Examination (MMSE)-score of < 24
  • Residents with a dominant belly sleeping position

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Residents

5 residents - fase 1 Intervention device: smart diaper (diaper, sensor and strips, without alerting system).

15 residents -fase 2, of which 5 residents of study phase 1 Intervention device: smart diaper (diaper, sensor and strips, with alerting system)
Device: Smart diapers

Residents receive standard continence care while using the smart diaper (without the alerting system) - fase 1

Diapers are changed as usual, e.g., after morning care, visual soiling, unpleasant odor, saturation, leakage.

Residents receive continence care while using the smart diaper with the alerting system - fase 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean percentage saturation
Time Frame: 10 days
The difference between the percentage saturation determined by the smart diaper and the percentage saturation based on the data registered in the frequency volume urine charts (FVUCs) (during each study period* for each diaper change)
10 days
The % of correct warnings
Time Frame: 10 days

= warning on saturation of the incontinence material) generated by the sensor.

a. Each warning generated by the sensor will be assessed by the nurse (correct/incorrect warning)
10 days
Frequency of skin irritations
Time Frame: 10 days
3. The frequency of skin irritations related to incontinence (Incontinence-Associated Dermatitis or IAD) in the gluteal/sacral area (assessed daily during each study period*).
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Ghent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2022

Primary Completion (Actual)

October 27, 2022

Study Completion (Actual)

November 27, 2022

Study Registration Dates

First Submitted

February 22, 2022

First Submitted That Met QC Criteria

March 29, 2022

First Posted (Actual)

April 7, 2022

Study Record Updates

Last Update Posted (Actual)

June 23, 2023

Last Update Submitted That Met QC Criteria

June 21, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • BC-09902

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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