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Home-based management of hypoxemic patients with acute respiratory tract infections. A complex intervention study with a randomized controlled trial embedded in a regional collaborative healthcare network.

Home-based management of hypoxemic patients with acute respiratory tract infections. A complex intervention study with a randomized controlled trial embedded in a regional collaborative healthcare network. - HOME-ART

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON57335
Enrollment
252
Registered
2024-12-03
Start date
2025-02-01
Completion date
Unknown
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lung infection pneumonia RTI lung infection

Interventions

For this HOME-ART intervention, we aim to align the medical treatment as closely as possible with regular hospital care. This means that patients who are randomized in the intervention group will re

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a patient must meet the following criteria: - Mentally competent adult (>=18 years) - Clinical diagnosis of community acquired respiratory tract infection in which hospital admission is considered required - Availability of informal caregiver who is willing to provide support at home and agrees to participate in the study program and understands its implications after being informed by the research staff - A good command of the Dutch language

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Patients who lack adequate digital proficiency to properly conduct digital aspects of the study - Respiratory distress requiring more than 5 litres of oxygen therapy to achieve comfort and a saturation of >= 94% at discharge from ER and/or a patient with clinical signs of respiratory exhaustion - Absence of haemodynamic stability at discharge from the ER, in which patient required > 2 500cc fluid challenges during ER admission and/or maintenance i.v. fluid suppletion is required - Patients requiring follow-up diagnostics in clinical setting - Serious risk of decompensation of pre-existent chronic illness, such as COPD, heart failure, immune deficiency, kidney- or liver failure, warranting hospital observation as judged by the responsible physician. - Hospital admission 30 days prior to ED presentation.

Design outcomes

Primary

MeasureTime frame
The main study endpoint will be the clinical effectiveness of the intervention, defined as the difference in mean number of days alive out of hospital (DOAH) within 30 days after randomization.

Secondary

MeasureTime frame
Secondary study outcomes are feasibility of the intervention in a regional network, safety (in terms of ICU admissions, delirium, all-cause mortality, patient's experienced safety during the intervention, disability-free survival within 30 days after randomization), health resources use, patient autonomy, strain on informal carers, user satisfaction and cost-effectiveness of the intervention.

Countries

Netherlands

Contacts

Public Contacta ahmad

Universitair Medisch Centrum Utrecht

a.ahmad-2@umcutrecht.nl0624593855

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: May 1, 2026