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

NCT05316012 | Completed DMC

• 1 other identifier: BC-09902
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Incontinence

Keywords

incontinence; sensor technology

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Residents

EXPERIMENTAL

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

Interventions

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

Residents

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Ghent: lead

Study Sites (1)

WZC Heilig Hart vzw

Oudenaarde, 9700, Belgium

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2022
• First Posted: April 7, 2022
• Study Start: June 20, 2022
• Primary Completion: October 27, 2022
• Study Completion: November 27, 2022
• Last Updated: June 23, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)