An Integrated Solution for Sustainable Care for Multimorbid Elderly Patients With Dementia

NCT05104593 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2023-08-30

No results posted yet for this study

Summary

The CAREPATH will conduct Technical Validation and Usability (TVU) study by involving ≥ 45 target end users (16 patients with MCI or mild dementia with their informal caregivers and 16 healthcare professionals from various disciplines) and Clinical Investigation (CI) study involving ≥ 200 patients (≥ 100 users to pilot the CAREPATH platform and ≥ 100 patients as reference cases). Both of these pilot studies will be coordinated in four European countries (Spain, Romania, Germany and UK) with diverse health and social care systems, ICT landscape/digital maturity of healthcare provision and dementia national programs, which will allow for strengthening the evidence base on health outcomes and efficiency gains.

The CAREPATH outcomes can be summarized as:

1. An Integrated Care Platform that jointly addresses multimorbidity, dementia and diminished intrinsic capacity and optimally manages healthcare interventions for its users (patients, informal caregiver, healthcare providers, etc).
2. Technical Validation and Usability (TVU) study involving over 45 users and Clinical Investigation (CI) involving over 200 patients that will be conducted in four European countries (Spain, Romania, Germany and UK) during two years and mobilizing the other necessary actors, such as caregivers and healthcare professionals, for the validation of healthcare interventions.
3. Dementia / Multimorbidity Guidelines that will be conceived for best healthcare delivery.
4. Health Economics Impact Assessment for healthcare cost effectiveness and care provision equalities. The incremental cost-effectiveness and the incremental cost-utility ratio would allow revealing the incremental cost (or the potential savings) per unit of benefit of switching from usual care to CAREPATH-an integrated patient-centred approach- in multimorbid elderly patients with dementia, and therefore, to determinate whether the CAREPATH approach would be considered as a cost-effective alternative.

Conditions

Interventions

OTHER

Intervention tested (CAREPATH)

The intervention tested will be the CAREPATH system. CAREPATH consists of an integrated, patient-centred, flexible and modular system that will provide a viable solution for the improvement of the management of multimorbid elderly patients with Mild Cognitive Impairment or mild dementia, with the help of clinicians. CAREPATH will act on patients and their informal caregivers, and its main objective is to empower multimorbid patients with MCI or mild dementia to manage their health condition together with their informal caregiver by providing assistance and reinforcement to follow their individual care plans, so independence and quality of life will increase for both of them. The intervention will provide a personalized care plan and activities proposal (treatment, activities proposal, lifestyle changes, referrals etc.) to patients and caregivers, considering the various sources of patient data available through the CAREPATH platform, and with the help of clinicians.

Sponsors & Collaborators

  • ECLEXYS SAGL

    collaborator UNKNOWN
  • The Fraunhofer-Gesellschaft

    collaborator OTHER
  • Klinikum Bielefeld

    collaborator OTHER
  • University of Warwick

    collaborator OTHER
  • University Hospitals Coventry and Warwickshire NHS Trust

    collaborator OTHER
  • University of Castilla-La Mancha

    collaborator OTHER
  • CENTRUL IT PENTRU STIINTA SI TEHNOLOGIE

    collaborator UNKNOWN
  • SRDC YAZILIM ARASTIRMA VE GELISTIRME VE DANISMANLIK TICARET ANONIM SIRKETI

    collaborator UNKNOWN
  • OCTILIUM SAGL

    collaborator UNKNOWN
  • Complejo Hospitalario Universitario de Albacete

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2024-01-01
Completion
2025-12-31

Countries

  • Spain

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 NCT05104593 on ClinicalTrials.gov