NCT07386275

Brief Summary

The objective of the study is to evaluate the impact caused by the use of the e-Salut Metro Nord App on the home hospitalization care process compared to the conventional model of care. A randomized clinical trial will be conducted with two groups: control group (patients using the conventional care model) and experimental group (patients using the app). The study population includes patients admitted to the Home Hospitalization Unit (HAD) of the Hospital Universitari Germans Trias i Pujol who agree to participate between January 2024 and April 2025. The independent variable is the use of the App. The dependent/outcome variables include: generated alerts, number of patient-initiated phone calls to professionals, App users who complete questionnaires, detected complications, unplanned in-person visits in HAD, unplanned phone visits in HAD, scheduled in-person nursing visits, scheduled medical visits, time elapsed between an alert and the professional's response, time for management and resolution of complications, unplanned visits generated by alerts, number of readmissions, patient/caregiver satisfaction, sex, age, functional assessment (Barthel Index), cognitive impairment assessment (Pfeiffer Test), anxiety and depression scales (HADS), patient activation measure (PAM-13), empowerment measure (CEPEC-47), therapeutic adherence test (ARMS-e), and health literacy (HLS-EU-Q16).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
202

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 4, 2026

Completed
Last Updated

February 5, 2026

Status Verified

February 1, 2026

Enrollment Period

1.3 years

First QC Date

January 19, 2026

Last Update Submit

February 3, 2026

Conditions

Keywords

Home Care Services, Hospital-BasedMobile Applicationstelemedicine

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Hospital Readmission Within 30 Days After Discharge From Hospital-at-Home

    Number of participants who experience at least one unplanned hospital readmission within 30 days after discharge from the Hospital-at-Home program.

    30 days post discharge

Secondary Outcomes (10)

  • Length of Stay in Hospital-at-Home (Days)

    From admission (day 0) to discharge (up to 30 days)

  • Source of Clinical Alerts During Hospital-at-Home

    Up to 30 days after Hospital-at-Home admission

  • Number of Participants With Unplanned Return to Hospital During Hospital-at-Home

    Up to 30 days after Hospital-at-Home admission

  • Number of Healthcare Visits by Modality During Hospital-at-Home

    Up to 30 days after Hospital-at-Home admission

  • Patient Empowerment Score Assessed by the 47-item Patient Empowerment in Chronic Conditions Questionnaire (CEPEC-47)

    Baseline and at discharge from Hospital-at-Home (mean 15 days)

  • +5 more secondary outcomes

Study Arms (2)

eSalut Program arm

EXPERIMENTAL

Patients admitted to home hospitalization who will use the eSalut digital platform with symptoms monitoring, alerts and communication with the care team.

Other: eSalut program arm

Control arm

OTHER

Patients admitted to home hospitalization receiving conventional care without the eSalut digital platform.

Other: Control arm

Interventions

Patients admitted to home hospitalization care with the eSalut digital platform.

Also known as: eSalut
eSalut Program arm

Patients admitted to home hospitalization receiving conventional care without the eSalut digital platform.

Also known as: Standard care
Control arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥18 years old
  • Admitted to HAD
  • Ability to read Spanish/Catalan
  • Minimum digital literacy
  • Smartphone/tablet with Android or iOS
  • Ability to answer calls and handle the App
  • Patient or caregiver can manage the device

You may not qualify if:

  • Patients living in nursing homes
  • Voluntary withdrawal
  • Complications requiring admission unrelated to study
  • Loss of patient or caregiver
  • No mobile device available

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospitalització a Domicili. Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Meritxell Davins Riu, RN, PhD

    Germans Trias i Pujol Hospital

    STUDY DIRECTOR
  • Sandra Cabrera Jaime, RN, PhD

    Institut Català d'Oncologia

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
The statistical analysis service anonymized the patients involved.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Randomized clinical trial with two parallel groups.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2026

First Posted

February 4, 2026

Study Start

January 1, 2024

Primary Completion

April 30, 2025

Study Completion

August 15, 2025

Last Updated

February 5, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations