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

Incontinence Clinical Trial

— Smart Diapers  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05316012
• Other study ID #: BC-09902
• Status: Completed
• Phase: N/A
• Start date: June 20, 2022
• Est. completion date: November 27, 2022

Study information

• Verified date: June 2023
• Source: University Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: November 27, 2022
• Est. primary completion date: October 27, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Incontinence

Intervention

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

Locations

Country	Name	City	State
Belgium	WZC Heilig Hart vzw	Oudenaarde

Sponsors (1)

Lead Sponsor	Collaborator
University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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