Effect of a Digital Multicomponent Delirium Intervention on Intensive Care Unit on Patients and Family Members: A Randomized Controlled Trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

DRKS

Registry ID

DRKS00037092

Enrollment

192

Registered

2025-07-14

Start date

2026-01-01

Completion date

Unknown

Last updated

2025-10-06

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

Conditions

F05.0

Interventions

Group 1: 91 Patients / 91 Relatives – Intervention group (multimodal digital delirium prevention) Group 2: 91 Patients / 91 Relatives – Control group (standard care)latives

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients Admitted to an intensive care unit (ICU) Expected ICU length of stay = 2 days RASS score between -2 and 3 upon admission At least one family member available to participate in the intervention Sufficient German language proficiency 2. Family Members Possession of a digital, internet-enabled device Sufficient German language proficiency

Exclusion criteria

Exclusion criteria: 1. Patients Persistent RASS = -3 over time Relevant auditory or visual impairment Receptive aphasia

Design outcomes

Primary

Measure	Time frame
Delirium incidence in patients	—

Secondary

Measure	Time frame
Psychological distress among relatives (HADS, PICS-F, IES-R) Quality of life in patients and relatives (EQ-5D-5L) Family involvement and satisfaction (B-IPQ, De Jong Gierveld Loneliness Scale)	—

Countries

Germany

Contacts

Public ContactEunkyeong Oh

Universitätsklinikum Hamburg Eppendorf

eunkyeong.oh@outlook.com+49 (0)40-7410-58933

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026