I-WEAR: From ICU to Recovery - Evaluating the Feasibility and Usability of Bi-Weekly Health Summaries Using Wearables in Patients After Intensive Care Unit Treatment - A Pilot Study

Status: Recruiting
Location: See location...
Intervention Type: Device, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Austria
Ludwig Boltzmann Institute Digital Health and Patient Safety
RECRUITING
Vienna
Contact Information
Primary
Akos Tiboldi, Dr.med.univ.
akos.tiboldi@lbg.ac.at
+43 660 7432550
Backup
Lisa Lichtenegger, BSc MSc
lisa.lichtenegger@lbg.ac.at
Time Frame
Start Date: 2025-07-01
Estimated Completion Date: 2026-05-30
Participants
Target number of participants: 60
Treatments
No_intervention: Standard care
Participants receive standard ICU follow-up care at the Medical University of Vienna without wearable devices or digital health tools.
Experimental: Wearables Only
Participants receive wearable health monitoring devices (Garmin Vivosmart 5, Garmin Index S2 Smart Scale, Garmin Index BPM blood pressure monitor) and use the Fitrockr application to visualize and track their data. No counseling or bi-weekly summaries are provided.
Experimental: Wearables + Summary + Counseling
Participants receive the same wearable devices and Fitrockr app as the Wearables Only group. In addition, they receive bi-weekly automatically generated health summaries via email and have the option to book lifestyle consultations with a member of the study team via Webex.
Related Therapeutic Areas
Sponsors
Leads: Ludwig Boltzmann Gesellschaft

This content was sourced from clinicaltrials.gov