CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 558 enrolled
Drug / intervention
PC4L solutionsdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05538455
NCT05538455N/ACompleted

ProCare4Life Pilot 3 Clinical Study: Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases

Casa di Cura Privata del Policlinico SpA·interventional·Posted Sep 13, 2022·Updated Aug 30, 2023

In Brief

A clinical study evaluating PC4L solutions for Neurodegenerative Diseases and 3 related conditions. Completed, enrolled 558 participants across 1 site.

Detailed Summary

Personalized Integrated Care Promoting Quality of Life for Elderly People (ProCare4Life, PC4L) project was created to finalize a digital platform with integrated sensors , for monitoring the health status of the elderly subjects with neurodegenerative diseases and comorbidities. In fact, an integrated care platform - able to establish correlations between comorbidities, investigate the intake of different drugs, mitigate potential health risks, study the social variables and promote unified therapeutic procedures or social services - could help patients, caregivers, healthcare professionals and social health workers to monitor various diseases parameters. The main contribution of the PC4L project is to propose an integrated, scalable and interactive care system that can be easily adapted to the reality of various chronic diseases, care institutions and end-user needs, for the benefit of all the actors involved. The main expected results are to improve patients' quality of life, enable an active life and better disease management, support professionals in decision making, facilitate efficient communication between all stakeholders and ensure reliable and secure access to data at the within Europe.

Study Details

Timeline

N/ACompletedFinished
2023202420252026
First PostedSep 13, 2022
Enrollment StartSep 30, 2022
Primary CompletionApr 30, 2023
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 3.8 years ago

Interventions

PC4L solutionsdevice

Two different versions of the PC4L system will be tested. A fully equipped version and a cloud-based system that requires only a smartphone and a wearable sensor (Fitbit Versa 2). 25% of participants will use the full system, the remaining 75% will use the cloud-based system. As part of the decision support system, the PC4L platform includes a recommendation component. This component collects information from different sources available (directly from sensors, cognitive games, questionnaires, and the multimodal fusion engine), and under clinical and professional guidance, after evaluating the potential improvement or worsening of patients' conditions, issues personalized recommendations to address identified problems. The recommendations relate to the following areas: physical activities; sleep; cognitive; nutrition. These recommendations will generally be sent to the PC4L application on the patients' smartphone, where they will appear as pop-up notifications.