JMIR Publications

ABSTRACT

Background:

People with profound intellectual and multiple disabilities (PIMD) cannot communicate their need for changing their incontinence products. Smart continence care (SCC), product: Abena Nova, signals caregivers when change is needed. This provides the opportunity for more person-centered care, increased quality of life, and decreased number of leakages. Yet, there is a need for evidence of the (cost)-effectiveness of such technology compared to regular continence care (RCC) for people with PIMD. This paper presents the research protocol for a (cost)-effectiveness study with people with PIMD living in long-term care facilities in the Netherlands.

Methods:

A cluster randomized trial will be conducted in three consecutive waves across 6 long-term care providers for disabled people and 160 participants with PIMD. Long-term care providers are randomized at a 1:1 ratio resulting in an intervention group and a group continuing RCC. The intervention group will receive implementation guidance and use SCC for 3 months; the other group will continue their continence care as usual and then switch to SCC. The study consists of three components: (1) effectiveness study, (2) economic evaluation, and (3) process evaluation. The primary outcome will be a change in the number of leakages. Secondary outcomes are quality of life, the difference in the number of changes, work perception of caregivers, and cost-effectiveness and cost-utility. Data collection will occur at T0 (baseline), T1 (6 weeks), T2 (12 weeks), and a 9-month follow-up (T3) for the first two intervention groups. An intention-to-treat analysis will be performed. The economic evaluation will be conducted alongside the trial from the societal and long-term care provider perspective. Qualitative data collection through interviews and field notes will complement these quantitative results and provide input for the process evaluation. Discussion: This study will provide insights into the (cost)-effectiveness of smart continence care for people with PIMD, allowing healthcare organizations to make informed decisions about implementing such a technology. It is the first time such a large-scale (cost)effectiveness study is conducted for people with PIMD.