An interventional study of PC4L solutions in Neurodegenerative Diseases, Parkinson Disease and Alzheimer Disease, sponsored by Casa di Cura Privata del Policlinico SpA. Completed at 1 site in Italy. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2023-08-30.
Sponsored by Casa di Cura Privata del Policlinico SpA · Not applicable, Interventional, and Supportive care
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Among 67 studies in Neurodegenerative Diseases with a site in Italy — 15 open to participants now, 22 under way, 2 of them phase 3. Neurodegenerative Diseases · Italy.
Among the 67 studies in Neurodegenerative Diseases with a site in Italy, this one is the 8th largest by enrollment of the 45 interventional ones that give a count, is one of 5 that started in 2022, is one of 16 with no phase, and was the 35th registered.
436 studies on the registry are indexed under Neurodegenerative Diseases; 143 are open to participants now.
Browse Neurodegenerative Diseases studies →15 of the 67 studies in Neurodegenerative Diseases with a site in Italy are open now. Recruiting first, the newest first:
Istituti Clinici Scientifici Maugeri SpA · Sites in Italy
Ages 40–90 · Healthy volunteers
Azienda Sanitaria Universitaria Integrata del Trentino · Sites in Italy
Ages 18+
Istituti Clinici Scientifici Maugeri SpA · Sites in Italy
Ages 40–85 · Healthy volunteers
MapLight Therapeutics · Sites in Italy, United States, Argentina and 12 more countries
Ages 55–90
IRCCS Eugenio Medea · Sites in Italy
Ages 8–60
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 101 Neurodegenerative Diseases studies recruiting now, 52 (51%) set no upper age limit and 11 (11%) stop at 75 or younger; 20 take children under 18; 49 take healthy volunteers.
This study: 65 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
67 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 14 · Phase 3 16
First in 2005; this study’s year is marked. 5 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 558 is above the median of 54 across 265 interventional studies indexed under Neurodegenerative Diseases.
Median enrollment 139 across the 45 interventional studies, 256 across the 21 observational. Of the 36 that completed or were terminated, 12 (33%) have results posted.
This tab as a report to print or save as PDF → With an account.
28 of 67 have an industry lead sponsor. The 10 most frequent:
Casa di Cura Privata del Policlinico SpA is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Casa di Cura Privata del Policlinico SpA has 1 study filed under Neurodegenerative Diseases — fewer than ten, so there is no comparison to draw.
6 of the studies in Neurodegenerative Diseases with a site in Italy that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07870070Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoFunctionalized Point of Care and 3D Printed Dental Aligners as Devices for Early Detection of Neurodegenerative Diseases | 2027-01-31 |
| NCT06185764Vertex Pharmaceuticals IncorporatedA Phase 1/2 Study of VX-670 in Adult Participants With Myotonic Dystrophy 1 (DM1) | 2027-02-02 |
| NCT07567664IRCCS San RaffaeleTracking and Predicting How Brain Damage Spreads in Neurodegenerative Diseases | 2027-02-15 |
| NCT06739967Istituti Clinici Scientifici Maugeri SpASpeech and Language Interventions for Italian People With PPA | 2027-02-28 |
| NCT06869135Fondazione Don Carlo Gnocchi ETSSaliva and Extracellular Vesicles for Neurodegenerative Diseases | 2027-03 |
Add all 6 to your calendar (.ics) → With an account.
Among the 67 studies in Neurodegenerative Diseases with a site in Italy, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
There is an urgent need to increase the efficiency and sustainability of health and social care systems across Europe, as there is a growing trend in public spending, which is expected to reach 14% of GDP by 2030. The main causes are the aging of the population, and the increase of chronic diseases, including cardiovascular diseases, diabetes, asthma, mental and physical disorders and neurodegenerative conditions. Comorbidities and the confluence of various chronic diseases is increasingly common in the elderly, which increases the need to develop models and tools to improve integrated health systems.
Population aging has also led to major reforms in long-term care policies and systems in many European countries, increasing the need for alternatives. This implies the need for help with housework or other practical errands, transportation by doctors or social visits, social companionship, emotional guidance, or help in organizing professional care. In most European countries, much of the care people over 60 receive is informal care.
Among the most common chronic diseases in the elderly population, neurocognitive deterioration in the stages of dementia associated with Alzheimer's and Parkinson's are the most disabling. Today, more than 10 million Europeans live with neurocognitive disorders in stages of dementia.
This situation can be improved through the creation of an integrated care platform, able to establish correlations between co-morbidities, investigate the use of the intake of different drugs, mitigate potential health risks, study the social variables involved and promote unified therapeutic procedures or social services. This solution could help patients, health professionals and social health workers to monitor various diseases, also considering the social context. In addition, people with chronic diseases face difficulties in their daily life and need specialized care services and care. This situation imposes high burdens on the public budget, which require particular attention to adequately address the sustainability of the social and health system in Europe.
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 (e.g. patients, caregivers and health experts). 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.This study is part of the European multicenter project Horizon 2020, called Personalized Integrated Care Promoting Quality of Life for Elderly People (ProCare4Life, PC4L), which involves several European partners and was created with the aim of finalizing a digital platform with integrated sensors, aimed at home monitoring of health status and treatment of the elderly patient with Parkinson's disease or Alzheimer's disease and other dementias.The PC4L Project was funded by the European Community Horizon 2020 innovation and research program (grant agreement No 875221), for the development of an international research project aimed at exploring the potential of assistive technologies in monitoring the behavior of elderly subjects. The project involves in fact the elderly population suffering from chronic neurological diseases and other comorbidities such as diabetes mellitus and arthritis. This project also aims to provide home support to the caregivers of subjects affected by these diseases.
PC4L-Pilot3 represents the third and last large-scale pilot study within the project, where the first one was aimed to explore feasibility and usability of the solution, and the second one investigated the characteristics of the metrics generated by the PC4L platform in real-life conditions.
In this pilot study, six clinical centers are involved, in five different European countries (Italy, Spain, Portugal, Romania, Germany), operating in the neurological context both at hospital and home care, as well as daycare centers.
An interventional, multicenter, randomized controlled trial will be conducted. The duration of the study per patient at home will be 3 months. Participants admitted to rehabilitation and daycare centers will use the PC4L platform for the entire duration of their stay in the center (not exceeding the 3 months).
Patients will be randomized into two groups: experimental group, which will use the PC4L platform for the duration envisaged by the study and will receive notifications and recommendations from the system; and the control group, which will follow the recommendations in paper form for the period envisaged by the study. Caregivers and health professionals will also be involved.
In-person assessments will take place at baseline and at the end of the study (3-month follow-up or at discharge from the rehabilitation/daycare program).
Demographic and clinical data (age, gender, level of education, professional activity, social support, previous use of technology) will be assesed at baseline. In-person assessments thorugh clinical evaluation will take place at baseline and at the end of the study (3-month follow-up or at discharge from the rehabilitation/daycare program). Clinical assessments are the following:
MDS Unified Parkinson's Disease Rating Scale (MDS-UPDRS) and Clinical Dementia Rating Scale (CDRS); Falls Self-Efficacy Scale (FES-I); Berg Balance test; Pittsburgh Sleep quality index score: State-Trait-Anxiety-Inventory (STAI); presence of festination, dysphasia, wandering episodes (last month); EuroQol5D3L; Barthel Index; patient satisfaction and empowerment (PACIC, SAPS); non-programmed medical resources used (last month); Cumulative Illness Rating Scale-Geriatric (CIRS-G) ; adverse events reporting; System Usability Scale (SUS) ; end-of-study survey (Global satisfaction with a 5-point Likert scale; What do you like most/least? Suggestions); end-of-study open questions (Which type of recommendations have you been using? How did you find the recommendations? how it helped in improving your wellbeing? What did you like the most/least?).
The PROCare4Life ecosystem consists of:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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.
Time frame: up to three months
MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Change in the score of MDS-UPDRS measured at baseline and at the end of the study. Higher scores mean worse outcome.
Time frame: up to three months
CLINICAL DEMENTIA RATING SCALE (CDRS)
Change in the score of CDRS measured at baseline and at the end of the study. It yields a single score on a scale of 0-5, where higher scores mean worse outcome.
Time frame: up to three months
Falls Efficacy Scale International (FES-I)
Change in the score of FES-I measured at baseline and at the end of the study. It yields a single score on a scale of 16-64, where higher scores mean worse outcome.
Time frame: up to three months
Pittsburgh Sleep quality index (PSQI)
Change in the score of PSQI measured at baseline and at the end of the study. It yields a single score on a scale of 0-21, where higher scores mean worse outcome.
Time frame: up to three months
State-Trait-Anxiety-Inventory (STAI)
Change in the score of STAI measured at baseline and at the end of the study. It yields a single score on a scale of 20-80, where higher scores mean worse outcome.
Time frame: up to three months
Barthel Index (BI)
Change in the score of BI measured at baseline and at the end of the study. It yields a single score on a scale of 0-100, where higher scores mean better outcome.
Time frame: up to three months
Patient assessment of chronic illness care (PACIC)
Change in the score of PACIC measured at baseline and at the end of the study. It yields a single score on a scale of 0-5, where higher scores mean better outcome.
Time frame: up to three months
Short Assessment of Patient Satisfaction (SAPS)
Change in the score of SAPS measured at baseline and at the end of the study. It yields a single score on a scale of 0-28, where higher scores mean better outcome.
Time frame: up to three months
Cumulative Illness Rating Scale-Geriatric (CIRS-G)
Change in the score of CIRS-G measured at baseline and at the end of the study . It yields a single score on a scale of 0-56, where higher scores mean worse outcome.
Time frame: up to three months
System Usability Scale (SUS)
SUS is used to measure how easy or difficult the proposed system is to use. We will compare the usability of two different versions of the PC4L system (fully equipped and cloud-based solution). It yields a single score on a scale of 0-100, where higher scores mean better outcome.
Time frame: up to three months
Plan to share: No
Ran from Sep 2022 to primary completion in Apr 2023, 7 months.
Of 75 non-industry interventional studies with no phase under Neurodegenerative Diseases, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 57. This study's 7 months is below that.
Counting every sponsor, half of 82 studies reached it within 35 months; a quarter within 11 and three quarters within 67.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Casa di Cura Privata del Policlinico SpA