Clinical trial Recruiting at 1 site Interventional Ages 18 to 65

Wearables and digital health summaries to support ICU survivors' recovery

Official title: 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

Run by Ludwig Boltzmann Gesellschaft · NCT07035106 · Data updated 2026-11-12

This pilot will test whether wearable devices plus optional twice-monthly digital health summaries help adults 18–65 recover after an ICU stay, focusing on people with diabetes or coronary artery disease.

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Quick facts

Study typeInterventional
Ages18 Years to 65 Years
SexAll
Enrollment60 (estimated)
SponsorLudwig Boltzmann Gesellschaft
Academic / other
Locations1 site (Vienna)
StatusRecruiting
StartedJuly 1, 2025
Main results expectedFebruary 28, 2026
Study endsMay 30, 2026
Registry record updatedSeptember 9, 2025
Trial IDNCT07035106 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are ICU survivors aged 18–65 who had an ICU stay of at least 48 hours, have diabetes and/or coronary artery disease, live in Austria, and have a smartphone and home internet.

Probably not a fit

Patients without smartphone or internet access, those living outside Austria, those without the specified comorbidities, or those with implanted pacemakers/defibrillators are unlikely to benefit from participation.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center, randomized feasibility pilot in Vienna will enroll 60 ICU survivors and assign them to standard follow-up, wearables only, or wearables plus bi-weekly health summaries and optional lifestyle consultations. Participants use a smartwatch, smart scale, and blood pressure monitor with data aggregated via a secure cloud app, and they are followed for six months. Primary outcomes are feasibility (recruitment, retention, device adherence) and usability (System Usability Scale and interviews), with secondary outcomes including health-related quality of life. Results will inform whether larger trials of remote monitoring and digital summaries are worthwhile for post-ICU care.

Why it matters

Potential benefit: If successful, this approach could enable earlier detection of recovery problems and more personalized follow-up, potentially improving quality of life after ICU discharge.

How similar studies have gone: Remote monitoring and wearable-based programs have shown promise in chronic cardiac and diabetes care, but using wearables specifically for post-ICU recovery is relatively novel with limited prior trial data.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Ludwig Boltzmann Institute Digital Health and Patient Safety
    Vienna, Austria
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.