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

NCT05538455 | Completed

• 1 other identifier: PC4L-Pilot3
• Study Type: interventional
• Target: 558
• Locations: 1 country
• Sites: 1

Brief 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

Neurodegenerative Diseases; Parkinson Disease; Alzheimer Disease; Quality of Life

Outcome Measures

Primary Outcomes (1)

• EuroQol5D3L

  Improvement of the quality of life in the 'experimental' group of patients who use the PC4L platform for a period of three months, compared to the control group, equal to 10% according to the scale EuroQol5D3L: the primary outcome of the study will be the difference in quality of life between groups, measured by the EuroQol5D3L scale at the end of the study. Sample size calculation was based on a previous study (Fan X, et al. Assessment of Health-Related Quality of Life between People with Parkinson's Disease and Non-Parkinson's: Using Data Drawn from the '100 for Parkinson's' Smartphone-Based Prospective Study. Int J Environ Res Public Health. 2018) that compared the quality of life of two groups of patients. It was estimated that a total of 558 patients, 279 per study group, will be necessary to achieve an improvement of 10% in EuroQol5D3L, with 95% power.

  up to three months

Secondary Outcomes (10)

• MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

  up to three months

• CLINICAL DEMENTIA RATING SCALE (CDRS)

  up to three months

• Falls Efficacy Scale International (FES-I)

  up to three months

• Pittsburgh Sleep quality index (PSQI)

  up to three months

• State-Trait-Anxiety-Inventory (STAI)

  up to three months

Study Arms (2)

Experimental group, use of PC4L solutions

EXPERIMENTAL

Participants who will use the PC4L solutions for the estabilished period of time, in the selected scenario (home, neurorehabilitation and daycare centers), and will receive recommendations in the PC4L app

Device: PC4L solutions

Control group, no use of PC4L solutions

NO INTERVENTION

Participants who will be monitored for the estabilished period of time, in the selected scenario (home, neurorehabilitation and daycare centers), and will only receive written recommendations

Interventions

PC4L solutions DEVICE

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.

Experimental group, use of PC4L solutions

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients with a clinical diagnosis of Parkinson's (Hoehn and Yahr between II and IV) or another parkinsonian syndrome, Alzheimer's disease, or another dementia
• years of age or more
• Willingness to participate in the study
• Able and willing to provide informed consent or have a legal representative responsible for the signature

You may not qualify if:

• Presence of fever and / or acute infection such as COVID19 / flu

Sponsors & Collaborators

• Casa di Cura Privata del Policlinico SpA: lead
• Asociación Parkinson Madrid: collaborator
• Universität Münster: collaborator
• Wohlfahrtswerk für Baden-Württemberg: collaborator
• Campus Neurológico Sénior: collaborator
• Carol Davila University of Medicine and Pharmacy: collaborator
• Spitalul Universitar de Urgență București: collaborator
• International Foundation for Integrated Care: collaborator
• Kineticos: collaborator

Study Sites (1)

Casa di Cura del Policlinico

Milan, MI, 20144, Italy

Location

Related Publications (21)

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• Judica E, Tropea P, Bouca-Machado R, Marin M, Calarota E, Cozma L, Badea R, Ahmed M, Brach M, Ferreira JJ, Corbo M. Personalized Integrated Care Promoting Quality of Life for Older People: Protocol for a Multicenter Randomized Controlled Trial. JMIR Res Protoc. 2023 Jul 24;12:e47916. doi: 10.2196/47916.

  PMID: 37486732 DERIVED

Related Links

• The future of healthcare in Europe
• ProCare4Life website

MeSH Terms

Conditions

Neurodegenerative Diseases; Parkinson Disease; Alzheimer Disease

Condition Hierarchy (Ancestors)

Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Dementia; Tauopathies; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients will be randomized on a 1: 1 ratio to intervention (use the PC4L system) and control group (no intervention) by an independent non-clinical partner of the consortium. The control group will be assessed at baseline and will receive general written recommendations on the main areas (physical activity, sleep, cognitive, nutrition; social support and stress management for caregivers). At the follow-up, after three months, the same group will be assessed on quality of life using specific scales (EuroQoL53L). The platform will be installed by one of the project's clinical partners in different scenarios. Two different versions of the PC4L system will be tested. A fully equipped version, used in the previous 2 pilots, as well as a cloud-based system that requires only a smartphone and a wearable sensor (Fitbit Versa 2). Of those patients using the PC4L system, 25% will use the full system, the remaining (75%) will use the cloud-based system.

Study Record Dates

• First Submitted: August 26, 2022
• First Posted: September 13, 2022
• Study Start: September 30, 2022
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)