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

University Ghent

Status: Completed

Conditions: Incontinence

Treatments: Device: Smart diapers

Study type: Interventional

Funder types: Other

Identifiers

NCT05316012

BC-09902

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

Residents

Experimental group

Description:

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)

Treatment:

Device: Smart diapers