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

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.

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Key information

Conditions

Incontinence

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

WZC Heilig Hart vzw

Oudenaarde, 9700, Belgium

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Smart diapers

Device

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

Primary outcomes

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)
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)
Frequency of skin irritations

Time frame: 10 days
- The frequency of skin irritations related to incontinence (Incontinence-Associated Dermatitis or IAD) in the gluteal/sacral area (assessed daily during each study period*).

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Registry information

Acronym: Smart Diapers

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2022
First posted: Apr 7, 2022
Registry last updated: Jun 23, 2023

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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Completed