NCT05481840

The (Cost)Effect of Smart Diaper Continence Care for People With Profound Intellectual and Multiple Disabilities

Status unknown NA Last updated 1 August 2022

What this trial tests

NA trial testing Continence material with sensor in Incontinence in 160 participants. Status unknown.

Timeline

28 July 2021

Primary endpoint
28 February 2023

28 February 2023

Quick facts

Lead sponsor	Academy Het Dorp
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	160
Start date	28 July 2021
Primary completion	28 February 2023
Estimated completion	28 February 2023
Sites	5 locations across Netherlands

Drugs / interventions tested

• Continence material with sensor

Conditions studied

• Incontinence — all drugs for Incontinence →

Sponsor

Academy Het Dorp

Who can join

18 and older, any sex, with Incontinence. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background and study aims

Most people with profound intellectual and multiple disabilities (PIMD) use diapers. When living in a long-term care facilities, most changes of diapers are scheduled. Leading to leakages, unnecessary changes and burden to people with PIMD and their caregivers.

With the use of continence material with sensor (smart diapers) caregivers give more client-based continence care. The smart diaper (product name: Abena Nova) informs the caregivers about the saturation level of the diaper and gives a notification when change is needed or a leakage might occur. This can result in less leakages compared to regular continence care. And we will research the effect on quality of life and number of pad changes and cost effectiveness. The study also investigates the effect on the care givers.

Who can participate?

People with profound intellectual and multiple disabilities, of 18 years and older, who use diapers and live in one of the participating disability care organizations.

What does the study involve?

To investigate the effect, the disability care organization will be assigned to one of the two groups. In one group we will research the use of the smart diaper, the other group will continue their regular continence care.

Data collection started September 2021 and will continue roughly till February 2023. Research period for each location is 12 weeks, with 3 points for data collection. For the first two organization who are using the smart diaper, there is also data collection after 9 months.

Caregivers will fill out questionnaires about the quality of life, received healthcare of the participant, and keep a one week diary about the diaper changes and leakages.

To use the smart diaper, caregivers will receive training, there are meetings to optimize usage and the disability care organization will receive help from the researchers.

Possible benefits and risk of participating?

The potential benefit of participating lays within the organization itself, optimizing continence care and investigating whether this is cost effective. Any negative effect is the cost of the product and the additional time and effort it takes to start using smart diapers. For the patients the benefit is getting more optimized continence care. Any potential discomfort or risk (such as removing of swallowing the sensor) will be evaluated before the start. Any negative advice will result in not implementing the smart diaper for this person showing risk behavior. However, any of these adverse events cannot be complete diminished.

Where does the study run from?

Study is run by Academy Het Dorp, one of the researcher is also affiliated with Tranzo, Tilburg University

Who is funding the study?

ZonMW is funding the research activities. Disability care organization are themselves paying for the smart diapers.

Who is the main contact?

Vivette van Cooten, MSc [e-mail]

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Smart Continence Care for People With Profound Intellectual and Multiple Disabilities: Protocol for a Cluster Randomized Trial and Trial-Based Economic Evaluation.
   van Cooten VJC, Gielissen MFM, van Mastrigt GAPG, den Hollander W, et al · · 2022 · cited 6× · PMID 36413389 · DOI 10.2196/42555
2. Effectiveness of Smart Continence Care for People With Profound Intellectual and Multiple Disabilities: Cluster Randomized Trial.
   van Cooten VJ, Gielissen MF, den Hollander W, van Mastrigt GA, et al · · 2025 · cited 1× · PMID 40743514 · DOI 10.2196/66389
3. Smart Continence Care for People With Profound Intellectual and Multiple Disabilities Within Dutch Residential Care Facilities: Economic Evaluation Alongside a Cluster Randomized Trial.
   van Cooten VJ, van Mastrigt GA, Gabrio A, Evers SM, et al · · 2025 · PMID 41071602 · DOI 10.2196/72017