Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases

NCT05538455 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 558

Last updated 2023-08-30

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

PC4L solutions

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.

Sponsors & Collaborators

  • Asociación Parkinson Madrid

    collaborator OTHER
  • Universität Münster

    collaborator OTHER
  • Wohlfahrtswerk für Baden-Württemberg

    collaborator UNKNOWN
  • Campus Neurológico Sénior

    collaborator OTHER
  • Carol Davila University of Medicine and Pharmacy

    collaborator OTHER
  • Spitalul Universitar de Urgență București

    collaborator UNKNOWN
  • International Foundation for Integrated Care

    collaborator UNKNOWN
  • Kineticos

    collaborator UNKNOWN
  • Casa di Cura Privata del Policlinico SpA

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-30
Primary Completion
2023-04-30
Completion
2023-04-30

Countries

  • Italy

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05538455 on ClinicalTrials.gov