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

NCT05575336 | Completed

• 1 other identifier: 875209
• Study Type: interventional
• Target: 185
• Locations: 5 countries
• Sites: 7

Brief 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

Keywords

Advanced chronic conditions; NYHA III-IV; >2 GOLD Scale; Multimorbidity; Personalized care; Integrated care; Early detection; Clinical decision support services; Patient and informal caregiver empowerment; Shared decision making; Patient Reported Outcome Measures (PROMs); Outcome-based care; Quality of life

Outcome Measures

Primary Outcomes (1)

• Change from baseline patient visits to the emergency (ER) department at the follow-up period (3-12 months)

  Change from Baseline in the number of patient visits to the emergency (ER) department during the follow-up month-period. Data collected from EHR.

  The primary outcome will be observed for the follow-up period, 3-12 months after the baseline.

Secondary Outcomes (21)

• Change from baseline Patient-Reported Outcome Measurements (PROMs) on health-related quality of life at the follow-up period (3-12 months)

  The change in the health related quality of life of the patient measured by means of EQ-5D-5L will be observed for the follow-up period (3-12 months), starting from the baseline

• Change from baseline PPatient-Reported Outcome Measurements (PROMs) on mood/emotional health at the follow-up period (3-12 months)

  The change in the mood/emotional health of patient measured by means of HADS-Hospital Anxiety and Depression Scale will be observed for the follow-up period (3-12 months), starting from the baseline.

• Change from baseline Patient-Reported Outcome Measurements (PROMs) on the ability of patients to perform tasks that are required to live independently in the community measured by Lawton scale at the follow-up period (3-12 months)

  The change on the ability of patients to perform tasks that are required to live independently in the community measured by means of Lawton scale will be observed for the follow-up period (3-12 months), starting from the baseline

• Change from baseline capability of the patient to perform basic activities in daily life at the follow-up period (3-12 months)

  The change on the capability of the patient to perform basic activities in daily reflecting the ability to function independently life measured by means of Barthel index will be observed for the follow-up period (3-12 months), starting from the baseline

• Change from baseline Patient-Reported Outcome Measurements (PROMs) on health status in patients with heart failure at the follow-up period (3-12 months)

  The change on health status in patients measured by means Kansas City Cardiomyopathy Questionnaire score questionnaire will be observed for the follow-up period (3-12 months), starting from the baseline

Study Arms (2)

Intervention group

EXPERIMENTAL

Use of the ADLIFE system

Other: ADLIFE intervention

Control group

NO INTERVENTION

Patients will receive the Standard of Care

Interventions

ADLIFE intervention OTHER

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.

Intervention group

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• The informal caregiver will be a person who provides occasional or regular support to the patient's needs. Caregivers are eligible if:
• They give consent to participate
• 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.

You may not qualify if:

• Patients are not eligible for recruitment if:
• Presence of active malignant neoplastic disease.
• 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.

Sponsors & Collaborators

• Biosistemak Institute for Health Systems Research: lead
• NHS Lanarkshire: collaborator
• Odense University Hospital: collaborator
• Assuta Ashdod Hospital: collaborator
• University Hospitals Coventry and Warwickshire NHS Trust: collaborator
• Gesunder Werra-Meißner-Kreis GmbH: collaborator
• Maccabi Healthcare Services, Israel: collaborator
• Osakidetza: collaborator

Study Sites (7)

Odense University Hospital

Odense, Region Syddanmark, 5000, Denmark

Location

Gesunder Werra-Meißner-Kreis GmbH

Eschwege, Hesse, 37269, Germany

Location

Maccabi Healthcare Services Southern Region

Ashdod, 7744142, Israel

Location

Assuta Ashdod Hospital

Ashdod, 7747629, Israel

Location

Osakidetza

Vitoria-Gasteiz, Araba, 01006, Spain

Location

UNIVERSITY HOSPITALS COVENTRY AND WARWICKSHIRE NHS Trust

Coventry, Warwickshire, CV2 2DX, United Kingdom

Location

NHS Lanarkshire

Glasgow, United Kingdom

Location

Study Officials

• Esteban de Manuel

  Instituto de Investigación en Servicios de Salud KRONIKGUNE

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A quasi-experimental trial following a multicentre, non-randomized, non-concurrent, unblinded and controlled design. Patients belonging to the intervention group will be under the ADLIFE intervention, while patients on the control group will follow the standard of care (SoC). The mixed-method approach will provide scientific evidence based on the effectiveness, socio-economic, implementation and technology acceptance assessment of ADLIFE intervention compared to the SoC when applied in real-life settings. The quantitative outcomes will be analysed not only at the individual level but also at the health organisation level.

Study Record Dates

• First Submitted: September 22, 2022
• First Posted: October 12, 2022
• Study Start: February 1, 2023
• Primary Completion: July 31, 2024
• Study Completion: September 15, 2024
• Last Updated: March 10, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); DK (1); IL (2); ES (1); GB (2)