JMIR Publications

ABSTRACT

Background:

Alzheimer's disease (AD) and Parkinson's disease (PD) are the two most common neurodegenerative diseases affecting millions of people worldwide. The project Personalized Integrated Care Promoting Quality of Life for Older People (PROCare4Life) proposes an integrated scalable and interactive care ecosystem that can be easily adapted to the needs of several neurodegenerative and chronic diseases, care institutions and end-user requirements.

Objective:

The study protocol developed in the framework of PROCare4Life project aims to iteratively test the integrated platform and its modules, and focuses primarily on assessing the impact of the proposed solution (PC4L platform) on patients’ quality of life, as well as its usability and feasibility on a large scale sample size in 3 different scenarios (home, neurorehabilitation and daycare centers).

Methods:

A prospective multicenter clinical study is conducted in 5 European countries: Germany, Italy, Portugal, Romania, and Spain at 6 different pilot centers, for 3 months, in patients with Parkinson, parkinsonism, Alzheimer’s disease and other dementias. Patients were randomized in a ratio of 1:1 to the intervention (use the PC4L system) and control group (no intervention). The PC4L system consists mainly of a wristband for monitoring parameters such as steps and levels of physical activity, and the PC4L app, which includes different engaging functionalities. Both groups are assessed with baseline and end-of-study clinical evaluations, including assessment of quality of life through EuroQoL-5D scale.

Results:

The study protocol is part of a project approved and funded by the European Commission Horizon 2020 (grant agreement No. 875221). The ethics committees of all involved centers reviewed and approved the study protocol. The study began with the recruitment phase in August 2022, and enrollment was end in February 2023. Recruitment is now closed (April 2023). The results of this study are expected to be published in summer 2023. 558 patients, 279 per study group, were recruited. The results will allow to clarify the impact of PROCare4Life on quality of life, will assess the empowerment of patients and the medical resources use, as well as the usability of the final version of the PC4L system. It will also provide information on the support of the system as a tool to facilitate the decision-making process.

Conclusions:

PROCare4Life project intends to test a technology-based, integrated, scalable, and interactive care platform on patients suffering from neurodegenerative diseases proposing a good coordinated care model between all involved actors. Future developments of PC4L solution may involve caregivers and socio-health professionals in the decision-making process, in order to facilitate efficient communication between all stakeholders, and ensure reliable and protected access to data within Europe. Clinical Trial: ClinicalTrials.gov NCT05538455; https://clinicaltrials.gov/ct2/show/NCT05538455.