RecruitingNot ApplicableNCT07035106

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

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

Sponsor

Ludwig Boltzmann Gesellschaft

Enrollment

60 participants

Start Date

Jul 1, 2025

Study Type

INTERVENTIONAL

Conditions

Coronary Artery Disease Critical Illness Recovery Post Intensive Care Syndrome (PICS)

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

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria6

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 Criteria8

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

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Interventions

DEVICEWearable 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.

BEHAVIORALDigital 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.