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Effectiveness and cost-effectiveness of a smart urinary incontinence management solution for people with a profound intellectual disablity: an innovative client-centered care approach.

Effectiveness and cost-effectiveness of a smart urinary incontinence management solution for people with a profound intellectual disablity: an innovative client-centered care approach. - Incontinence care product with a sensor for intellectual disabled people

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON49668
Enrollment
208
Registered
2021-08-09
Start date
2021-07-28
Completion date
Unknown
Last updated
2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

loss of bladder control urinary incontinence

Interventions

The Abena Nova makes client-oriented incontinence care possible. Thanks to MediSens Wireless's sensor technology, the moisture content in the incontinence care product can be accurately measured to

Sponsors

Academy Het Dorp
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Clients with a severe multiple disability Clients who cannot feel themselves and / or indicate that change of incontinence care product is necessary. The care provider (in consultation with the client's legal representative) indicates that the use of the Abena Nova meets the care needs of the client. Healthcare providers Healthcare provider who provides care for a client who participates in this study and is willing to collect data: number of leaks, quality of life of the client through observation, and anwering questions on work-related well-being Informal caregiver An informal caregiver of a participating client who is willing to evaluate the quality of life of the client through observation.

Exclusion criteria

Exclusion criteria: not applicable, ref. inclusion criteria

Design outcomes

Primary

MeasureTime frame
The number of leaks (subdivided into leaks with change of clothing and / or bedding) per client per week is the primary outcome measure. Leaks with associated changing activities are very disruptive for clients. Moreover, this has the most impact on the workload (changing clothes and bedding is time-intensive and physically demanding) of caregivers.

Secondary

MeasureTime frame
Quality of life of the client Quality of life (Mood Interest and Pleasure Questionnaire (MIPQ) recommended in the "Basic Minimum Data Set for intellectual disability of ZonMw") is an important secondary outcome measure. The MIPQ has been developed to validate and evaluate the state of mind of adults with profound multiple disabilities in a valid and reliable way through observation. The MIPQ will be completed by both the caregiver and an informal caregiver. Work-related well-being Work-related well-being will be assessed by means of an interview with the care providers (qualitative data). Topics include experienced work pace and work quantity, involvement, job satisfaction, interactions with colleagues, mental and physical strain. Parameters incontinence care During the study, data on incontinence care will be collected at all measurement moments during one week in both the intervention condition (use of the Nova) and in the waiting list control condition (standard care): number of changes per 24 hours; number of unnecessary changes; time investment of a change; skin health and any skin problems / care for skin problems; material and washing costs. This data are also important for the cost-effectiveness and utility analysis. Cost-effectiveness analysis The economic evaluation concerns a combination of a cost-effectiveness analysis (KEA) and a cost-utility analysis (KUA). In the KEA, the incremental cost-effectiveness ratio (IKER) is expressed as the incremental cost per improvement on number of leaks per week.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jul 23, 2026