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

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.

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 Overview

• Status: Enrolling by invitation
• Conditions: Incontinence
• Intervention / Treatment: Device: Continence material with sensor

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Amersfoort, Netherlands
    • 's Heeren Loo
  • Arnhem, Netherlands
    • Siza
  • Eindhoven, Netherlands
    • Lunet
  • Heerhugowaard, Netherlands
    • Esdégé-Reigersdaal
  • Wilp, Netherlands
    • Zozijn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Receiving smart continence care by the use of continence material with sensor, in which their care professionals receive a notification when change is needed.	Device: Continence material with sensor; 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.; Other Names: Abena Nova with Medisens, Abena Nova, Nova
No Intervention: Waiting list group; Will continue regular continence care as received by their care professionals. After data collection is finalized, they will receive smart continence care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in baseline of number of leakages of continence pads per week at 12 weeks	Measured by using a week long continence diary	Baseline (week 0) and at 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in number of changes of continence pads per week	Measured using a week long continence diary	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.	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).	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).	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.	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.	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.	Baseline (week 0) and week 12

Collaborators and Investigators

• Sponsor: Academy Het Dorp
• Collaborators: Maastricht University; Tilburg University; Trimbos-instituut; s Heeren Loo Zorggroep; Esdégé-Reigersdaal; Lunet; Siza; Zozijn
• Investigators: Principal Investigator: Brigitte Boon, Prof. Dr., Academy Het Dorp, Arnhem, The Netherlands

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2021
• Primary Completion (Anticipated): February 28, 2023
• Study Completion (Anticipated): February 28, 2023

Study Registration Dates

• First Submitted: July 26, 2022
• First Submitted That Met QC Criteria: July 28, 2022
• First Posted (Actual): August 1, 2022

Study Record Updates

• Last Update Posted (Actual): August 1, 2022
• Last Update Submitted That Met QC Criteria: July 28, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: quality of life; Incontinence; cost-effectiveness; healthcare technology; smart diaper; profound and intellectual disabilities; leakages
• Other Study ID Numbers: AHD19.022; 80-85300-98-19110 (Other Grant/Funding Number: ZonMw); NL72751.091.20 (Other Identifier: CCMO)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No