Assessment of the Effectiveness, Socio-economic Impact and Implementation of a Digital Solution for Severe Patients

NCT05575336 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 185

Last updated 2025-03-10

No results posted yet for this study

Summary

ADLIFE is a EU-funded project developing innovative digital health solutions to support healthcare planning and care delivery for patients with advanced chronic conditions (chronic obstructive pulmonary disease and/or heart disease failure). ADLIFE's technology innovations will be deployed, used and evaluated in seven healthcare environments in Spain, the UK, Sweden, Germany, Denmark, and Israel.

ADLIFE intends to impact three stakeholders: patients, informal caregivers and health professionals, and consequently across the seven participating international healthcare systems. ADLIFE intervention aims at slowing down the patients' functional deterioration, ensuring their quality of life and promoting shared decision making, reducing the caregiver burden, and improving the health professional working conditions; all this under the scenario of an improvement in the healthcare resource use.

The research aims to prove whether the ADLIFE intervention can deliver appropriate targeted and timely care for patients with severe long-term diseases when applied in real-life settings. Based on a mixed-method approach, the study will provide scientific evidence based on the effectiveness, socio-economic, implementation and technology acceptance assessment of ADLIFE compared to the standard of care (SoC) to provide scientific evidence supporting the funding decision-making of the ADLIFE intervention.

Conditions

  • Heart Failure NYHA Class III
  • Heart Failure NYHA Class IV
  • Chronic Obstructive Pulmonary Disease Severe

Interventions

OTHER

ADLIFE intervention

The ADLIFE toolbox will be deployed, used and evaluated in seven healthcare environments to demonstrate the effectiveness of the ADLIFE intervention in clinical real conditions. Patients participating in ADLIFE will have a personalised care plan, created in the ADLIFE toolbox, developed and managed together with their healthcare professionals. PCPMP will be used within clinical sites´ ICT systems to create patient care plans based on most recent clinical data, following clinical evidence. The main task of patients and informal caregivers will be to use the ADLIFE toolbox as part of their healthcare process together with their healthcare professionals. Patients recruited will use the ADLIFE system during the pilot study for a follow-up period between 3 and 12 months.

Sponsors & Collaborators

  • NHS Lanarkshire

    collaborator OTHER_GOV
  • Odense University Hospital

    collaborator OTHER
  • Assuta Ashdod Hospital

    collaborator OTHER
  • University Hospitals Coventry and Warwickshire NHS Trust

    collaborator OTHER
  • Gesunder Werra-Meißner-Kreis GmbH

    collaborator UNKNOWN
  • Maccabi Healthcare Services, Israel

    collaborator OTHER
  • Osakidetza

    collaborator OTHER
  • Biosistemak Institute for Health Systems Research

    lead OTHER

Principal Investigators

  • Esteban de Manuel · Instituto de Investigación en Servicios de Salud KRONIKGUNE

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-01
Primary Completion
2024-07-31
Completion
2024-09-15

Countries

  • Denmark
  • Germany
  • Israel
  • Spain
  • United Kingdom

Study Locations

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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 NCT05575336 on ClinicalTrials.gov