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

Not Applicable

Completed

• Conditions: Incontinence

• Registration Number: NCT05316012
• Lead Sponsor: University Ghent

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-22
• Study First Submitted QC: 2022-03-29
• Study First Posted: 2022-04-07
• Study Start: 2022-06-20
• Primary Completion: 2022-10-27
• Study Completion: 2022-11-27
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-21
• Last Update Posted: 2023-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Mean percentage saturation	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	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	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\*).

Trial Locations

Locations (1)

WZC Heilig Hart vzw; 🇧🇪 Oudenaarde, Belgium