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Clinical Trials in Austria / NCT07035106
Recruiting Not applicable

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

NCT07035106 · tracked via the Priya Life Science Austria tracker
Sponsor
Ludwig Boltzmann Gesellschaft
Phase
Not applicable
Started
2025-07-01
Last updated
2025-09-09

Condition(s) studied

Post-Intensive Care Syndrome (PICS)Critical Illness RecoveryCoronary Artery Disease

Investigational drug(s) / intervention(s)

Wearable Health MonitoringDigital Health Summary and Lifestyle Counseling

Wearable Health Monitoring: Participants receive a Garmin Vivosmart 5, Garmin Index S2 Smart Scale, and Garmin Index BPM blood pressure monitor for daily health tracking. Devices sync to the Fitrockr mobile application.

Digital Health Summary and Lifestyle Counseling: Participants receive bi-weekly health summaries via email generated from wearable data and may opt in to monthly video-based lifestyle consultations with trained study staff.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * Age 18-65 years at the time of ICU admission * ICU stay of at least 48 hours * ICU discharge within the last 2 years * Comorbidity of diabetes mellitus and/or chronic heart failure/coronary artery disease * Written informed consent * Access to a home internet connection and smartphone with internet and Bluetooth Exclusion Criteria: * Presence of a legal guardian * No smartphone or internet access * No cardiovascular disease/event and/or diabetes * Implanted pacemaker or defibrillator * Allergies to materials in the wearable devices * Transfer from an ICU outside the Medical University of Vienna * Homelessness * Residence outside of Austria

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Ludwig Boltzmann Institute Digital Health and Patient Safety Vienna Austria Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07035106 on ClinicalTrials.gov ↗ ← All trials in Austria