Clinical trial NCT05481840: The (Cost)Effect of Smart Diaper Continence Care for People With Profound Intellectual and Multiple Disabilities
Official title: The (Cost)Effect of Continence Material With Sensor for People With Profound Intellectual and Multiple Disabilities: Client-based Continence Care by Innovation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Incontinence
Keywords: Incontinence
healthcare technology
smart diaper
profound and intellectual disabilities
leakages
quality of life
cost-effectiveness
Lead sponsor: Academy Het Dorp
Sponsor class: OTHER
Collaborators: name: Tilburg University
name: Stichting Trimbos-Instituut
name: Maastricht University
name: s Heeren Loo Zorggroep
name: Esdégé-Reigersdaal
name: Lunet
name: Siza
name: Zozijn
First posted: 2022-08-01
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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


Eligibility criteria: Inclusion:

* 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

Exclusion:

* No informed consent of legal representative
* Risk of harmful behavior such as pica disorder

Primary outcomes:
measure: Change in baseline of number of leakages of continence pads per week at 12 weeks
timeFrame: Baseline (week 0) and at 12 weeks
Secondary outcomes:
measure: Change in number of changes of continence pads per week
timeFrame: Baseline (week 0), week 6, week 12 and 9 months
measure: Health status measured by EuroQoL (Quality of Life)-5 Dimensions (EQ-5D-5L proxy 1) of people with PIMD
timeFrame: Baseline (week 0), week 12 and 9 months
measure: Subjective wellbeing scores assessed by MIPQ of people with PIMD
timeFrame: Baseline (week 0), and week 12
measure: Objective quality of life scores assessed by QOL-PMD of people with PIMD
timeFrame: Baseline (week 0), and week 12
measure: Cost effectiveness of providing smart continence care
timeFrame: at week 6, week 12 and 9 months
measure: Cost utility of providing smart continence care
timeFrame: at week 12 and 9 months
measure: Effect on work engagement for caregivers when using smart continence care
timeFrame: Baseline (week 0) and week 12
Other outcomes:
Locations:
city: Amersfoort
country: Netherlands
facility: 's Heeren Loo
city: Arnhem
country: Netherlands
facility: Siza
city: Eindhoven
country: Netherlands
facility: Lunet
city: Heerhugowaard
country: Netherlands
facility: Esdégé-Reigersdaal
city: Wilp
country: Netherlands
facility: Zozijn
Study officials:
affiliation: Academy Het Dorp, Arnhem, The Netherlands
name: Brigitte Boon, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: