NCT05575336Completed
Assessment of the Effectiveness, Socio-economic Impact and Implementation of a Digital Solution for Severe Patients
Integrated Personalized Care for Patients with Advanced Chronic Diseases to Improve Health and Quality of Life
Source: ClinicalTrials.gov · Last updated 10 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 185 (actual)
- First submitted
- 22 Sept 2022
- Start date
- 1 Feb 2023
- Primary completion date
- 31 Jul 2024
- Lead sponsor
- Biosistemak Institute for Health Systems Research
- Diseases
- Heart failure, COPD
- NCT number
- NCT05575336
What you commit to
- Study type: Interventional
- Participants enrolled: 185
- From 1 Feb 2023 to the primary completion date, 31 Jul 2024
- 7 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Inclusion in the active list of any kind of transplantation.
Other illness
- Presence of active malignant neoplastic disease.
Other
- PATIENTS-Exclusion criteria
- Patients are not eligible for recruitment if:
- No signature of Informed consent by a legally capable patient.
- Patients who have participated in ADLIFE and later have withdrawn from their participation in the study the intervention formally are not eligible for recruitment again.
- INFORMAL CAREGIVERS-Exclusion criteria
- -Caregivers are not eligible if the patients they care for meet the exclusion criteria.
- HEALTHCARE PROFESSIONALS-Exclusion criteria
- Healthcare professionals are not eligible if they do not care for patients who meet the inclusion criteria or only care for patients who meet the exclusion criteria.
Who the study is looking for
- PATIENTS-Inclusion criteria
- Senior (over 55)
- Heart failure (NYHA III-IV) in functional stage III/IV according to the NYHA scale and stages C and D of the ACCF/AHA classification. Stable phase (at least two months without decompensation requiring hospital care)
- And/or COPD (FEV1\<50), \>2 GOLD scale, and/or mMRC ≥ 2 and/or CAT ≥ 10 and/or use of oxygen at home
- With or without comorbidities
- They are able to provide informed consent
- They still live and generally plan on living in their home for the intervention duration
- They or their informal caregivers are able to use digital technology, communication tools, and/or networks and have access to a computer, laptop, tablet or smartphone and wifi/internet connection.
- They or their informal caregivers understand, read and talk the native language.
- INFORMAL CAREGIVERS- Inclusion criteria
- The informal caregiver will be a person who provides occasional or regular support to the patient's needs. Caregivers are eligible if:
- The patients they care for meet the inclusion criteria
- They give consent to participate
- HEALTHCARE PROFESSIONALS-Inclusion criteria
- Healthcare professionals are eligible if they care for patients who meet the inclusion criteria and consent to participate. Healthcare professionals taking part in ADLIFE should be:
- involved in the selected patients' care.
- open to new ways of working, specifically as part of coordinative and collaborative teams.
- open to the use of new technology. They should be willing to learn how to use technology to support their work.
Age in the registry: 55 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Gesunder Werra-Meißner-Kreis GmbH Coordinator of this site? Confirm its status | Eschwege | Germany | Unknown status |
| Odense University Hospital Coordinator of this site? Confirm its status | Odense | Denmark | Unknown status |
| Osakidetza Coordinator of this site? Confirm its status | Vitoria-Gasteiz | Spain | Unknown status |
| University Hospitals Coventry and Warwickshire NHS Trust Coordinator of this site? Confirm its status | Coventry | United Kingdom | Unknown status |
| NHS Lanarkshire Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Unknown status |
| Assuta Ashdod Hospital Coordinator of this site? Confirm its status | Ashdod | Israel | Unknown status |
| Maccabi Healthcare Services Southern Region Coordinator of this site? Confirm its status | Ashdod | Israel | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.