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

Study Overview
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Brief Summary
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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.

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

Conditions
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Incontinence

Intervention / Treatment
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* Device: Smart diapers


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Residents<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean percentage saturation | 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 | = 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sensor technology, incontinence