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

NCT ID: NCT05316012

Last Updated: 2023-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-20
• Study Completion Date: 2022-11-27

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Residents

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)

Group Type: EXPERIMENTAL

Smart diapers

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

WZC Heilig Hart vzw

Oudenaarde, , Belgium

Countries

Belgium

Other Identifiers

BC-09902

Identifier Type: -

Identifier Source: org_study_id