Clinical Trial

I-WEAR: Evaluating Wearables and Health Summaries in ICU Survivors

Study acronym: I-WEAR
Recruiting
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Record status
This record was last updated September 9, 2025 (before its estimated February 28, 2026 completion). Its status may not reflect the trial's current state.
Summary
This pilot study investigates the use of wearable health technology and bi-weekly digital health summaries in patients recovering from intensive care. Many patients experience physical, psychological, and cognitive challenges after an ICU stay, a condition known as Post-Intensive Care Syndrome (PICS). The study aims to evaluate the feasibility and usability of wearable devices-such as smartwatches, blood pressure monitors, and smart scales-for tracking recovery in real-world settings. Participants will be randomly assigned to one of three groups: standard ICU follow-up care, wearable use only, or wearable use combined with bi-weekly health reports and optional lifestyle consultations. The study will assess participants' quality of life, experience using the technology, and adherence over a 6-month period. Results will inform the future use of digital tools in post-ICU care.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-06-16.
Status change: Not Yet Recruiting → Recruiting 2025-09-02
Trial Details
NCT Number NCT07035106
Lead Sponsor Ludwig Boltzmann Gesellschaft
Conditions Post-Intensive Care Syndrome (PICS), Critical Illness Recovery, Coronary Artery Disease
Enrollment 60 participants
Start Date 2025-07-01
Primary Completion 2026-02-28 (estimated)
Study Completion 2026-05-30 (estimated)
Updated on ClinicalTrials.gov 2025-09-09