IncontinenceNCT05481840
The (Cost)Effect of Smart Diaper Continence Care for People With Profound Intellectual and Multiple Disabilities
A study testing Continence material with sensor in people with Incontinence, run by Academy Het Dorp at 5 sites in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incontinence
- What is being tested?
- Continence material with sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 5 sitesNetherlands
- Study dates
- 28 Jul 2021to 28 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: ≥18 years
- Gender: male of female
- People with PIMD
- Living in a long-term care facility
- Using continence pads
- Not able to indicate the need for change of continence pads
- Caregivers see added value for use of smart continence pads
Who cannot join
- No informed consent of legal representative
- Risk of harmful behavior such as pica disorder
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Netherlands5 sites
's Heeren Loo
Amersfoort
Siza
Arnhem
Lunet
Eindhoven
Esdégé-Reigersdaal
Heerhugowaard
Zozijn
Wilp
About this study
Official title: The (Cost)Effect of Continence Material With Sensor for People With Profound Intellectual and Multiple Disabilities: Client-based Continence Care by Innovation
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.
Read more
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 Vivette.van.cooten@academyhetdorp.nl
- Conditions
- Incontinence
- Being tested
- Continence material with sensor
- Keywords
- Incontinence, healthcare technology, smart diaper, profound and intellectual disabilities, leakages, quality of life, cost-effectiveness
- Medical subject headings
- Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continence material with sensorDevice
Also called Abena Nova with Medisens, Abena Nova, Nova
Healthcare organizations are prepared for the use of smart continence care (for the intervention condition) using specially developed implementation guideline. They receive training, including how to apply continence material (only provided to intervention condition).
Each participating location will use the product for 12 weeks. Correct size and absorption level will be determined for each participant. The optimize the result, this can change. Evaluation meetings with the caregivers, supplier and researcher will be held. Resulting in suggestions for alterations in continence care provided or products used, or giving indications that a team needs support in any way to foster the implementation.
After 12 weeks, the implementation guidance from the research group will be phased out.
The waiting list group will continue their continence care as usual during data collection period. Thereafter they will receive support for implementing smart continence care.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Receiving smart continence care by the use of continence material with sensor, in which their care professionals receive a notification when change is needed. Receives: Device: Continence material with sensor |
| Waiting list group | No intervention | Will continue regular continence care as received by their care professionals. After data collection is finalized, they will receive smart continence care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in baseline of number of leakages of continence pads per week at 12 weeks
Measured by using a week long continence diary
Measured: Baseline (week 0) and at 12 weeks
Secondary outcomes (7)
Change in number of changes of continence pads per week
Measured using a week long continence diary
Measured: Baseline (week 0), week 6, week 12 and 9 months
Health status measured by EuroQoL (Quality of Life)-5 Dimensions (EQ-5D-5L proxy 1) of people with PIMD
Proxy (healthcare provider and if available relative) of person with PIMD fills out EuroQoL (EQ-5D-5L proxy 1) questionnaire resulting in a health status and VAS score of health of the person with PIMD.
Measured: Baseline (week 0), week 12 and 9 months
Subjective wellbeing scores assessed by MIPQ of people with PIMD
Proxy (healthcare provider and if available relative) of person with PIMD fills out Mood Interest and Pleasure questionnaire about person with PIMD, resulting in an overall score of subjective wellbeing between 0 (lowest subjective wellbeing score) and 100 (highest subjective wellbeing score).
Measured: Baseline (week 0), and week 12
Objective quality of life scores assessed by QOL-PMD of people with PIMD
Proxy (healthcare provider and if available relative) of person with PIMD fills out Quality of Life of people with Profound Multiple Disabilities questionnaire about person with PIMD, resulting in an overall score of objective wellbeing between 0% (lowest objective quality of life score) and 100% (highest objective quality of life score).
Measured: Baseline (week 0), and week 12
Cost effectiveness of providing smart continence care
The cost effectiveness is measured by calculating the costs of the intervention and compare it with the financial benefits (cost reductions) due to the intervention. This includes direct healthcare costs (healthcare resource use) and related costs as laundry costs.
Measured: at week 6, week 12 and 9 months
Cost utility of providing smart continence care
It calculates the financial costs (resulting from cost effectiveness analysis) to the additional QALY's (quality adjusted life years) gained when using smart continence care, compared to not using smart continence care. QALY is the outcome of the EUROQOL, health state. The Dutch tariff will be used to calculate the QALY from these health states.
Measured: at week 12 and 9 months
Effect on work engagement for caregivers when using smart continence care
This questionnaire includes questions about work pressure and satisfaction.
Measured: Baseline (week 0) and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start28 Jul 2021
- Primary completion28 Feb 2023 (estimated)
- Study completion28 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a cluster randomized trial with a intervention group and waiting list group. Six organization will participate. They will be divided into one of the three couples. Within this couple randomization will take place at organization level, resulting in one organization receiving the intervention and a parallel group continuing regular continence care. The couples will start the research consecutively, after the previous couple finished the research (hence stepped). Due to the nature of the intervention (smart continence products) the randomization is not blinded.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Academy Het Dorp
- Sponsor type
- University, hospital or other
- Collaborators
- Tilburg University, Stichting Trimbos-Instituut, Maastricht University, s Heeren Loo Zorggroep, Esdégé-Reigersdaal, Lunet, Siza, Zozijn
- Responsible party
- Principal investigator, Brigitte Boon, Academy Het Dorp
- Investigators
- Brigitte Boon, Prof. Dr., Principal investigator, Academy Het Dorp, Arnhem, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05481840
- Sponsor's protocol ID
- AHD19.022
- Other IDs
- 80-85300-98-19110, NL72751.091.20
- Status last verified
- Jul 2022
- First submitted
- 26 Jul 2022
- Last updated
- 1 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
van Cooten VJ, van Mastrigt GA, Gabrio A, Evers SM, Gielissen MF, Boon B. Smart Continence Care for People With Profound Intellectual and Multiple Disabilities Within Dutch Residential Care Facilities: Economic Evaluation Alongside a Cluster Randomized Trial. J Med Internet Res. 2025 Oct 10;27:e72017. doi: 10.2196/72017.
PubMed 41071602van Cooten VJ, Gielissen MF, den Hollander W, van Mastrigt GA, Smeets O, Bongers IM, Boon B. Effectiveness of Smart Continence Care for People With Profound Intellectual and Multiple Disabilities: Cluster Randomized Trial. J Med Internet Res. 2025 Jul 31;27:e66389. doi: 10.2196/66389.
PubMed 40743514van Cooten VJC, Gielissen MFM, van Mastrigt GAPG, den Hollander W, Evers SMAA, Smeets O, Smit F, Boon B. Smart Continence Care for People With Profound Intellectual and Multiple Disabilities: Protocol for a Cluster Randomized Trial and Trial-Based Economic Evaluation. JMIR Res Protoc. 2022 Nov 22;11(11):e42555. doi: 10.2196/42555.
PubMed 36413389
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The (Cost)Effect of Continence Material With Sensor for People With Profound Intellectual and Multiple Disabilities: Client-based Continence Care by Innovation
- ClinicalTrials.gov ID
- NCT05481840
- Acronym / sponsor ID
- AHD19.022
- Conditions
- Incontinence
- Keywords
- Incontinence, healthcare technology, smart diaper, profound and intellectual disabilities, leakages, quality of life, cost-effectiveness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Academy Het DorpUniversity, hospital or other
- Collaborators
- Tilburg University, Stichting Trimbos-Instituut, Maastricht University, s Heeren Loo Zorggroep, Esdégé-Reigersdaal, Lunet, Siza, Zozijn
- Study start
- 28 Jul 2021 (actual)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- 28 Feb 2023 (estimated)
- First posted
- 1 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 Vivette.van.cooten@academyhetdorp.nl
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a cluster randomized trial with a intervention group and waiting list group. Six organization will participate. They will be divided into one of the three couples. Within this couple randomization will take place at organization level, resulting in one organization receiving the intervention and a parallel group continuing regular continence care. The couples will start the research consecutively, after the previous couple finished the research (hence stepped). Due to the nature of the intervention (smart continence products) the randomization is not blinded.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Continence material with sensorReceiving smart continence care by the use of continence material with sensor, in which their care professionals receive a notification when change is needed. |
| Waiting list group | No intervention | –Will continue regular continence care as received by their care professionals. After data collection is finalized, they will receive smart continence care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age: ≥18 years
- Gender: male of female
- People with PIMD
- Living in a long-term care facility
- Using continence pads
Key exclusion criteria (2 listed)
- No informed consent of legal representative
- Risk of harmful behavior such as pica disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continence material with sensorAlso: Abena Nova with Medisens, Abena Nova, NovaHealthcare organizations are prepared for the use of smart continence care (for the intervention condition) using specially developed implementation guideline. They receive training, including how to apply continence material (only provided to intervention condition). Each participating location will use the product for 12 weeks. Correct size and absorption level will be determined for each participant. The optimize the result, this can change. Evaluation meetings with the caregivers, supplier and researcher will be held. Resulting in suggestions for alterations in continence care provided or products used, or giving indications that a team needs support in any way to foster the implementation. After 12 weeks, the implementation guidance from the research group will be phased out. The waiting list group will continue their continence care as usual during data collection period. Thereafter they will receive support for implementing smart continence care. | Device | Intervention group |
Primary outcome
Change in baseline of number of leakages of continence pads per week at 12 weeks
Time frame: Baseline (week 0) and at 12 weeks
Measured by using a week long continence diary
7 secondary outcomes
Change in number of changes of continence pads per week
Time frame: Baseline (week 0), week 6, week 12 and 9 months
Health status measured by EuroQoL (Quality of Life)-5 Dimensions (EQ-5D-5L proxy 1) of people with PIMD
Time frame: Baseline (week 0), week 12 and 9 months
Subjective wellbeing scores assessed by MIPQ of people with PIMD
Time frame: Baseline (week 0), and week 12
Objective quality of life scores assessed by QOL-PMD of people with PIMD
Time frame: Baseline (week 0), and week 12
Cost effectiveness of providing smart continence care
Time frame: at week 6, week 12 and 9 months
Cost utility of providing smart continence care
Time frame: at week 12 and 9 months
Effect on work engagement for caregivers when using smart continence care
Time frame: Baseline (week 0) and week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2022.
- Derived from this study: PubMed 41071602van Cooten VJ, van Mastrigt GA, Gabrio A, Evers SM, Gielissen MF, Boon B. Smart Continence Care for People With Profound Intellectual and Multiple Disabilities Within Dutch Residential Care Facilities: Economic Evaluation Alongside a Cluster Randomized Trial. J Med Internet Res. 2025 Oct 10;27:e72017. doi: 10.2196/72017.
- Derived from this study: PubMed 40743514van Cooten VJ, Gielissen MF, den Hollander W, van Mastrigt GA, Smeets O, Bongers IM, Boon B. Effectiveness of Smart Continence Care for People With Profound Intellectual and Multiple Disabilities: Cluster Randomized Trial. J Med Internet Res. 2025 Jul 31;27:e66389. doi: 10.2196/66389.
- Derived from this study: PubMed 36413389van Cooten VJC, Gielissen MFM, van Mastrigt GAPG, den Hollander W, Evers SMAA, Smeets O, Smit F, Boon B. Smart Continence Care for People With Profound Intellectual and Multiple Disabilities: Protocol for a Cluster Randomized Trial and Trial-Based Economic Evaluation. JMIR Res Protoc. 2022 Nov 22;11(11):e42555. doi: 10.2196/42555.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brigitte Boon, Prof. Dr. principal investigator
Academy Het Dorp, Arnhem, The Netherlands
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continence material with sensor in people with Incontinence, run by Academy Het Dorp at 5 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in baseline of number of leakages of continence pads per week at 12 weeks (time frame: Baseline (week 0) and at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05481840, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2022.